Judicial Watch, the US-based public interest group that investigates and prosecutes government corruption, obtained information about Gardasil from the U.S. Food and Drug Administration under the provisions of the Freedom of Information Act. The first 6 pages of the Judicial Watch Special Report Examining the FDA’s HPV Vaccine Records are posted below.
At the end of page 4 and on page 5 is evidence which shows that the HPV vaccine has led to outbreaks in warts in some people, which was denied as occurring by Dr Nikki Turner of the NZ Immunization Advisory Center.
Furthermore, at the end of page 5 and at the top of page 6 is mention that Gardasil was found to enhance disease in recipients who already had “relevant HPV types” by 44.6 percent. In spite of this Helen Petousis-Harris of the NZ Immunisation Advisory Center stated in a letter to The Whangarei Report: “There is no evidence that Gardasil increases the risk of precancerous lesions.” It states on the Gardasil insert in section 14: “Infected women may already have CIN 2/3 or AIS at vaccination onset and some will develop CIN 2/3 or AIS during followup, either related to a vaccine…”
Judicial Watch findings are summarized in an article entitled Controversial HPV Vaccine Causing One Death Per Month: FDA Report by Peter J Smith and the Judicial Watch document cited is in full here. On the 27th of March, when one clicked on this link, a web page appeared which dissuaded people from accessing this information, by claiming the site could damage your computer, which is why I posted these 6 pages on this website. However, since writing this post, the warning page has been removed. If it is up again when you look and you are willing to take a risk, click on “Ignore this warning” at the bottom right-hand-side of the red panel. I did repeatedly and nothing adverse appears to have occurred to my computer.
A Judicial Watch Special Report
Examining the FDA’s
HPV Vaccine Records
Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment
June 30, 2008
Judicial Watch, Inc. 501 School Street, SW Suite 500 Washington, DC 20024
Tel: 202-646-5172 Fax: 202-646-5199 www.JudicialWatch.org
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
Page 1 of 24
This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil.
Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine was approved in May 2006 and was created and marketed by Merck & Company Incorporated.
The records include Merck’s patent and drug information submitted to the FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System (VAERS) documents detailing 8,864 cases of adverse effects experienced by people after receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have died after receiving Gardasil.1 Many health officials believe that adverse reactions to medications are widely underreported, therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be higher.
Judicial Watch obtained these records under the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. § 552. The request, asking for documents concerning Gardasil, was originally submitted to the FDA on May 9, 2007. The FDA produced documents on May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008.
Judicial Watch uncovered thousands of pages of material pertaining to Gardasil, which is designed to prevent cervical cancer. The controversial vaccine was fast-tracked for approval by the FDA despite concerns about Gardasil’s safety and long-term effects. The vaccine is still in the testing stages (final report due September 30, 2009), but it is already being administered to thousands of young girls and women.2 Mandatory vaccination has been opposed by the American College of Pediatrics and The New England Journal of Medicine. Legislators in 41 states and Washington, DC have introduced legislation to require, fund or educate the public about the HPV vaccine and 17 states have enacted legislation. Michigan, Texas and Virginia took steps toward mandatory vaccination for sixth grade girls; however, all three states have postponed that required mandate. 3
Judicial Watch is concerned by the facts detailed in the FDA’s adverse event
reporting associated with Gardasil. Merck has waged an aggressive lobbying campaign with state governments to mandate this HPV vaccine for young girls. Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children.
Christopher J. Farrell Tegan N. Millspaw
Director of Investigations & Research Lead Researcher & Principal Author
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
Page 2 of 24
In May 2007, Judicial Watch submitted a request to the FDA under the Freedom of Information Act for all records concerning Merck’s new anti-HPV vaccine, Gardasil.
After Judicial Watch filed a lawsuit in October 2007 to compel record production, the FDA finally released four sets of documents, the last in June 2008. These records detail the development and expedited approval of Gardasil. The documents include patent and licensing memoranda, test reports for the vaccine, and the final briefing document on Gardasil submitted to the FDA in April 2006, one month before the vaccine was
approved. The FDA also produced 8,864 VAERS reports. Judicial Watch uncovered a transcript of Merck’s May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at which the vaccine received a unanimous vote of approval.
Analysis of the records shows:
• Gardasil is a prophylactic, preventative vaccine and will not treat pre-existing HPV infection. It is not a cancer vaccine or cure.
• Gardasil is marketed as a vaccine that prevents cancer, but it “ . . . has not
been evaluated for the potential to cause carcinogenicity or genotoxicity.”
• Gardasil is not 100% effective against all HPVs. It is designed to protect
against only four strains of HPV, even though there are over thirty strains
including at least fifteen that can cause cancer.
• While Gardasil is the most expensive vaccine ever to be recommended by the FDA, its long-term effectiveness is unknown and could be as brief as only two to three years.
• During testing, an aluminium-containing placebo was used. Aluminium can cause permanent cell damage and is a reactive placebo, unlike most standard saline placebos. This means that tests of Gardasil may not have given an accurate picture of safety levels.
• Although some states are considering making it mandatory for young girls to get the Gardasil vaccine, it has only been tested with one other vaccine
commonly given to children. There are ten commonly administered
• Gardasil is still in the testing stages, and will not be fully evaluated for safety until September 2009. VAERS reports show that as many as eighteen people have died after receiving Gardasil.
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
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Genital Human Papillomavirus (HPV) is the most common sexually transmitted disease in the world, and the American Social Health Association reports that over 75% of people between the ages of fifteen and forty-nine have been infected with HPV. 4
There are over thirty strains of genital HPV. The Centers for Disease Control and Prevention (CDC) estimate that 6.2 million people become infected with HPV every year.5 Many people who are infected with HPV never show any symptoms and are unaware that they even have the disease. In most cases the body’s immune system will fight the virus and it will never become a problem.
Although most of the time HPV infection is not harmful, some strains may
eventually develop into cancer. These are called high-risk, carcinogenic strains. Two strains, HPV-16 and HPV-18, are responsible for approximately 70% of cervical cancer cases worldwide.6 According to the National Cancer Society, there are fifteen high-risk HPV strains. Other strains may cause genital warts. These strains will never develop into cervical cancer. A patient infected with a wart-causing HPV strain will not necessarily be at risk for cervical cancer because they are caused by different strains. The National Cancer Society also notes that “ . . . the great majority of high-risk HPV infections go away on their own and do not cause cancer.”7 Be that as it may, cervical cancer is still a very serious problem. The American Cancer Society predicts that 11,070 women will be diagnosed with cervical cancer in 2008. 8
HPV can be treated, but it cannot be cured.9 Due to the health risks associated with HPV, scientists at Merck developed an HPV vaccine called Gardasil. While scientists had been experimenting with HPV vaccines for decades, Merck was the first company to create and patent a vaccine. Gardasil is designed to guard against four types of HPV: two that can cause genital warts and two that may lead to cervical cancer. The vaccine is created from highly purified L1 proteins taken from actual HPV types. It is a
recombinant vaccine, which means that it is made from genetically engineered material taken from HPV, but it does not contain the live virus. The FDA explains that “because the vaccine only contains a protein, and not the entire virus, the vaccine cannot cause the HPV infection. It is the body’s immune response to the recombinant protein(s) that then protects against infection by the naturally occurring virus.”10 Gardasil works by
assembling itself into virus-like particles similar to actual HPV particles. Because the vaccine does not contain a viral DNA strand from HPV, it should not cause HPV or cancer. Instead, it ought to trigger an antibody reaction to guard the host from being infected with the virus.
Gardasil and the FDA
The FDA approved the marketing of Gardasil on June 8, 2006, after a six-month priority review process reserved for products with the potential to fill an unmet medical need. New cancer treatments or medications are often fast-tracked by the FDA, as well
Page 4 of 24
as treatments for AIDS, HIV, and other serious ailments. Most vaccines take at least ten months to review and process. While the FDA is not required to approve fast-tracked vaccines and medicines, it apparently did so due to support for the vaccine from both Merck representatives and recommendation from FDA advisory panels, as well as the Center for Disease Control’s (CDC) Advisory Committee on Immunization Practices
(ACIP) that recommended Gardasil in June 2006 for females between the ages of 9 and 26.11 The Director for the FDA’s Center for Biologics Evaluation and Research, Dr. Jesse Goodman, called Gardasil a “huge advance,” and added that the vaccine deserved a speedy review process because “ . . . its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible.”12 Now, almost two years later, it looks like the FDA may have approved Gardasil too quickly.
Judicial Watch submitted a Freedom of Information Act request to the FDA in May 2007, asking for information on HPV and Merck’s new vaccine. The FDA produced records, including Merck’s final report before the approval of the vaccine, and the transcript of the meeting in which the vaccine was approved. Judicial Watch has also requested VAERS records for the Gardasil vaccine. These documents raise questions concerning Merck’s testing methods, and the safety of Gardasil for the general public.
Among the documents obtained by Judicial Watch was a June 2006 memorandum to the FDA from Merck, describing the clinical testing and results for Gardasil. Merck conducted four placebo-controlled, double-blind tests for Gardasil, evaluating 20,541 women from the ages of 16 to 26 years. 27% of the test subjects had already been exposed to at least one of the four strains of HPV the vaccine is designed to protect against.13 Gardasil is a prophylactic, preventative drug, and will not treat pre-existing
HPV infection. Since Gardasil does not cure HPV, persons who already had any lesions or symptoms from pre-exposed strains were not counted in the study. This is problematic because many women have HPV without knowing it, and Gardasil does not require prescreening before vaccination. A study in the New England Journal of Medicine found that, “ . . . there was no clear evidence that vaccination altered the course of HPV-16 or HPV-18 infection that was present before administration of the first dose.”14
Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse. Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment. While Gardasil is marketed as a preventative vaccine, Merck still suggests that women who have been exposed to one or more HPV strains get the vaccine in the hope that it will protect them from the remaining strains. However, in VAERS
reports obtained by Judicial Watch there are 78 separate cases where, after receiving the vaccine, patients experienced outbreaks of warts. Below are excerpts from VAERS reports.
Two days after receiving the first dose of Gardasil, the patient developed groin warts. There is no known history of these warts. The patient came back in about a month later and was given the second dose of Gardasil.
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A few days after receiving the second dose, the patient had a huge outbreak of warts.
VAERS ID: 292052-1
* * *
Information has been received from a consumer concerning her 17-year-old daughter with no medical history and an allergy to sulfa, who on 28-SEP-2007 was vaccinated with a first dose of Gardasil . . . Prior to being vaccinated with Gardasil the patient was tested for HPV and genital warts and all her test came back negative. On 15-OCT-2007 the patient experienced a fever, and broke out with white bumps that were diagnosed as genital warts.
VAERS ID: 301339-115
Outbreaks were not limited simply to genital warts. Some patients experienced outbreaks of warts on the face, hands, and feet. All warts are caused by strains of the papilloma virus, but it is surprising that Gardasil, which was modeled to protect only against genital warts, would cause outbreaks of warts caused by other strains of the papilloma virus.
While some of the outbreaks reported were fairly mild, such as a few warts on the hands or feet, others were quite serious and symptoms persisted.
A 16-year-old female . . . was vaccinated with Gardasil. Subsequently, on an unspecified date the patient developed warts on hands after receiving Gardasil. Medical attention was sought. The patient’s warts on hands persisted. VAERS ID: 300862-1
* * *
My daughter began to have facial (flat) warts on her face and chest after the 2nd dose of Gardasil. There are many warts on her face and chest at least 20 or more. She has never had this problem before receiving the vaccine. She
was treated for warts by her Doctor and now has been referred to Dermatology. She has not recovered yet.
VAERS ID: 288998-116
The possibility that Gardasil could make HPV infections worse is very serious, and a matter of concern with both critics of the vaccine and the FDA. A background document produced by the FDA’s VRBPAC in May 2006 states:
There were two important concerns that were identified during the course of the efficacy review of this BLA [biologics license application]. One was the potential for
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Gardasil to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine relevant HPV types at baseline. The other concern was the observations of CIN 2/3 [cervical intraepithelial neoplasia, abnormal cell changes in moderate stage] or worse cases due to HPV types not contained in the vaccine. These cases of disease due to other HPV types have the potential to counter the efficacy results of Gardasil for the HPV types contained in the vaccine . . . The results of exploratory subgroup analyses . . . suggested a concern that
subjects who were . . . positive for the vaccine-relevant HPV types had a greater number of CIN 2/3 or worse cases. 17
A chart in the committee’s report revealed that efficacy in subjects already exposed to “relevant HPV types” had an observed efficacy rate of -44.6%. The disturbing efficacy rate raises questions as to who should be receiving the vaccine, and why the FDA allows Gardasil to be administered without prescreening for HPV. The outcomes that can result from pre-exposure are disconcerting and deserve far more attention.
It is possible that the FDA’s efficacy considerations for subjects already exposed to “relevant HPV types” is manifesting itself in the vaccine application review process. The FDA denied Merck’s application to expand marketing of Gardasil to women ages 27 through 45 on June 25, 2008. The FDA notified Merck by letter that there were “issues” that precluded approval of the company’s plans. 18
The FDA refused Judicial Watch’s June 26, 2008 request for a copy of the letter to Merck, stating that the letter may be made available under the provisions of the FOIA. Judicial Watch immediately filed a FOIA request for the letter. News media reporting on the FDA denial of Merck’s plans stated that the agency had specific questions regarding Gardasil’s effectiveness in this older age group. These outstanding questions appear to
parallel the VRBPAC observations of May 2006 (above).
Merck also failed to win approval from the FDA to expand the Gardasil vaccine to include additional strains of HPV. Merck has reportedly now dropped all plans to expand the vaccine. 19
An additional testing report shows that Merck tested Gardasil against an
aluminium-containing placebo. While most placebos are saline based, the FDA allowed Merck to use a placebo with an undisclosed amount of aluminium in it. Gardasil itself contains 225 mcg of aluminium. Aluminium can cause many serious problems including temporary and permanent nerve damage. Using a reactive aluminium-containing placebo instead of a non-reactive saline base can make vaccines seem safer than they may actually be. While Merck has repeatedly stated that Gardasil is on a comparable safety rate with the placebo, if the placebo itself is responsible for adverse effects then it is more difficult to ascertain the vaccine’s safety. Merck’s testing report shows charts of clinical tests, and compares Gardasil with the aluminum-containing placebo. The table below is the report’s documentation of all-cause common adverse effects 20:
1 See VAERS Report 282747-1 (D); Reporting on June 25, 2007, that a physician attending a conference who mentioned that additional two patients vaccinated with Gardasil subsequently died. Attempts reportedly being made to obtain additional information. VAERS reports available on the Internet at: <http://www.JudicialWatch.org/gardasil>.
2 See Tab E, 003.
3 National Conference of State Legislatures, “HPV Vaccine: State Legislation,” Updated June 4, 2008, <http://www.ncsl.org/programs/health/HPVvaccine.htm>, Accessed June 12, 2008.
4 American Social Health Association, “HPV, Human Papillomavirus: What Women Should Know,” <http://www.ashastd.org/learn/learn_hpv_women.cfm>, Accessed June 18, 2008.
5 The Centers for Disease Control and Prevention, “Genital HPV Infection-CDC Fact Sheet,” < http://www.cdc.gov/std/HPV/STDFact-HPV.htm >, Accessed June 18, 2008.
6 The New England Journal of Medicine, “Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions,” Vol. 356, No. 19, May 10, 2007.
7 National Cancer Institute, “Human Papillomaviruses and Cancer,” <
http://www.cancer.gov/ cancertopics/factsheet/Risk/HPV >, Accessed May 22, 2008.
8 American Cancer Society, “What Are the Key Statistics About Cervical Cancer?”, <http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics
_for_cervical_cancer_8.asp?rnav=cri>, Accessed June 18, 2008.
9 American Social Health Association, “HPV, Human Papillomavirus: What Women Should Know.”
10 Food and Drug Administration, “Product Approval Information-Licensing Action: Gardasil Questions and Answers,” <http://www.fda.gov/CBE /products/
hpvmer060806qa.htm>, accessed June 9, 2008.
11 The New England Journal of Medicine, “Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions.”
12 Dr. Jesse Goodman, quoted in The New York Times, “U.S. Approves Use of Vaccine for Cervical Cancer,” June 9, 2006.
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
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13 See Tab A, Merck & Co., Inc., GARDASIL Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, June 2006, 11.
14 The New England Journal of Medicine, “Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions.”
15 See Tab B, Food and Drug Administration, “VAERS Line List Report—Vaccine Type: HPV, HPV4,” report ran on June 10, 2008.
17 FDA, “VRBPAC Background Document: Gardasil HPV Quadrivalent Vaccine,” May 18, 2006, < http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf >, Accessed June 26, 2008.
18 Reuters, “Merck’s Gardasil Not Cleared for Older Women,” June 25, 2006, <http://uk.reuters.com/article/healthNews/idUKWNAS917720080626?pageNumber=2&
virtualBrandChannel=0&sp=true>, Accessed June 26, 2008.