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Date Created:June 30, 2008
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Judicial Watch Special Report Examining the FDAs HPV Vaccine Records Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices Large-Scale Public Health Experiment June 30, 2008 Judicial Watch, Inc. 501 School Street, Suite 500 Washington, 20024 Tel: 202-646-5172 Fax: 202-646-5199 www.JudicialWatch.org Introduction This Judicial Watch Special Report analysis records obtained from the Food and Drug Administration (FDA) concerning recent vaccine called Gardasil. Gardasil helps protect against four types human papillomavirus (HPV). The vaccine was approved May 2006 and was created and marketed Merck Company Incorporated. The records include Mercks patent and drug information submitted the FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, well Vaccine Adverse Event Reporting System (VAERS) documents detailing 8,864 cases adverse effects experienced people after receiving the Gardasil vaccine. VAERS reports show that least eighteen people have died after receiving Gardasil.1 Many health officials believe that adverse reactions medications are widely underreported, therefore the actual number adverse events occurring after vaccination with Gardasil likely higher. Judicial Watch obtained these records under the provisions the Freedom Information Act (FOIA), U.S.C. 552. The request, asking for documents concerning Gardasil, was originally submitted the FDA May 2007. The FDA produced documents May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008. Judicial Watch uncovered thousands pages material pertaining Gardasil, which designed prevent cervical cancer. The controversial vaccine was fast-tracked for approval the FDA despite concerns about Gardasils safety and long-term effects. The vaccine still the testing stages (final report due September 30, 2009), but already being administered thousands young girls and women.2 Mandatory vaccination has been opposed the American College Pediatrics and The New England Journal Medicine. Legislators states and Washington, have introduced legislation require, fund educate the public about the HPV vaccine and 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 concerned the facts detailed the FDAs adverse event reporting associated with Gardasil. Merck has waged aggressive lobbying campaign with state governments mandate this HPV vaccine for young girls. Given all the questions about Gardasil, the best public health policy would reevaluate its safety and prohibit its distribution minors. the least, governments should rethink any efforts mandate promote this vaccine for children. Thomas Fitton President Christopher Farrell Tegan Millspaw Director Investigations Research Lead Researcher Principal Author Executive Summary May 2007, Judicial Watch submitted request the FDA under the Freedom Information Act for all records concerning Mercks new anti-HPV vaccine, Gardasil. After Judicial Watch filed lawsuit October 2007 compel record production, the FDA finally released four sets documents, the last June 2008. These records detail the development and expedited approval Gardasil. The documents include patent and licensing memoranda, test reports for the vaccine, and the final briefing document Gardasil submitted the FDA April 2006, one month before the vaccine was approved. The FDA also produced 8,864 VAERS reports. Judicial Watch uncovered transcript Mercks May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which the vaccine received unanimous vote approval. Analysis the records shows: Gardasil prophylactic, preventative vaccine and will not treat pre-existing HPV infection. not cancer vaccine cure. Gardasil marketed vaccine that prevents cancer, but has not been evaluated for the potential cause carcinogenicity genotoxicity. Gardasil not 100% effective against all HPVs. designed protect against only four strains HPV, even though there are over thirty strains including least fifteen that can cause cancer. While Gardasil the most expensive vaccine ever recommended the FDA, its long-term effectiveness unknown and could brief only two three years. During testing, aluminum-containing placebo was used. Aluminum can cause permanent cell damage and reactive placebo, unlike most standard saline placebos. This means that tests Gardasil may not have given accurate picture safety levels. Although some states are considering making mandatory for young girls get the Gardasil vaccine, has only been tested with one other vaccine commonly given children. There are ten commonly administered adolescent vaccines. Gardasil still the testing stages, and will not fully evaluated for safety until September 2009. VAERS reports show that many eighteen people have died after receiving Gardasil. Background Genital Human Papillomavirus (HPV) the most common sexually transmitted disease the world, and the American Social Health Association reports that over 75% people between the ages fifteen and forty-nine have been infected with HPV.4 There are over thirty strains 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. most cases the body's immune system will fight the virus and will never become problem. Although most the time HPV infection 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% cervical cancer cases worldwide.6 According 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. patient infected with wart-causing HPV strain will not necessarily risk for cervical cancer because they are caused different strains. The National Cancer Society also notes that the great majority high-risk HPV infections away their own and not cause cancer.7 that may, cervical cancer still very serious problem. The American Cancer Society predicts that 11,070 women will diagnosed with cervical cancer 2008.8 HPV can treated, but cannot cured.9 Due the health risks associated with HPV, scientists Merck developed HPV vaccine called Gardasil. While scientists had been experimenting with HPV vaccines for decades, Merck was the first company create and patent vaccine. Gardasil designed guard against four types HPV: two that can cause genital warts and two that may lead cervical cancer. The vaccine created from highly purified proteins taken from actual HPV types. recombinant vaccine, which means that made from genetically engineered material taken from HPV, but does not contain the live virus. The FDA explains that because the vaccine only contains protein, and not the entire virus, the vaccine cannot cause the HPV infection. the body's immune response the recombinant protein(s) that then protects against infection the naturally occurring virus.10 Gardasil works assembling itself into virus-like particles similar actual HPV particles. Because the vaccine does not contain viral DNA strand from HPV, should not cause HPV cancer. Instead, ought trigger antibody reaction guard the host from being infected with the virus. Gardasil and the FDA The FDA approved the marketing Gardasil June 2006, after six-month priority review process reserved for products with the potential fill unmet medical need. New cancer treatments medications are often fast-tracked the FDA, well treatments for AIDS, HIV, and other serious ailments. Most vaccines take least ten months review and process. While the FDA not required approve fast-tracked vaccines and medicines, apparently did due support for the vaccine from both Merck representatives and recommendation from FDA advisory panels, well the Center for Disease Controls (CDC) Advisory Committee Immunization Practices (ACIP) that recommended Gardasil June 2006 for females between the ages and 26.11 The Director for the FDAs Center for Biologics Evaluation and Research, Dr. Jesse Goodman, called Gardasil huge advance, and added that the vaccine deserved speedy review process because its rapid approval underscores FDAs commitment help make safe and effective vaccines available quickly possible.12 Now, almost two years later, looks like the FDA may have approved Gardasil too quickly. Judicial Watch submitted Freedom Information Act request the FDA May 2007, asking for information HPV and Mercks new vaccine. The FDA produced records, including Mercks final report before the approval the vaccine, and the transcript the meeting which the vaccine was approved. Judicial Watch has also requested VAERS records for the Gardasil vaccine. These documents raise questions concerning Mercks testing methods, and the safety Gardasil for the general public. Among the documents obtained Judicial Watch was June 2006 memorandum 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 years. 27% the test subjects had already been exposed least one the four strains HPV the vaccine designed protect against.13 Gardasil prophylactic, preventative drug, and will not treat pre-existing HPV infection. Since Gardasil does not cure HPV, persons who already had any lesions symptoms from pre-exposed strains were not counted the study. This problematic because many women have HPV without knowing it, and Gardasil does not require prescreening before vaccination. study the New England Journal Medicine found that, there was clear evidence that vaccination altered the course HPV-16 HPV-18 infection that was present before administration the first dose.14 Not only will Gardasil not cure pre-existing HPV, can also make symptoms worse. Women who already have the virus without knowing could suffer massive outbreaks genital warts abnormal precancerous lesions, both which require extensive treatment. While Gardasil marketed preventative vaccine, Merck still suggests that women who have been exposed one more HPV strains get the vaccine the hope that will protect them from the remaining strains. However, VAERS reports obtained Judicial Watch there are separate cases where, after receiving the vaccine, patients experienced outbreaks warts. Below are excerpts from VAERS reports. Two days after receiving the first dose Gardasil, the patient developed groin warts. There known history these warts. The patient came back about month later and was given the second dose Gardasil. few days after receiving the second dose, the patient had huge outbreak warts. VAERS ID: 292052-1 Information has been received from consumer concerning her 17-year-old daughter with medical history and allergy sulfa, who 28-SEP-2007 was vaccinated with first dose Gardasil Prior being vaccinated with Gardasil the patient was tested for HPV and genital warts and all her test came back negative. 15-OCT-2007 the patient experienced fever, and broke out with white bumps that were diagnosed genital warts. VAERS ID: 301339-115 Outbreaks were not limited simply genital warts. Some patients experienced outbreaks warts the face, hands, and feet. All warts are caused strains the papilloma virus, but surprising that Gardasil, which was modeled protect only against genital warts, would cause outbreaks warts caused other strains the papilloma virus. While some the outbreaks reported were fairly mild, such few warts the hands feet, others were quite serious and symptoms persisted. 16-year-old female was vaccinated with Gardasil. Subsequently, unspecified date the patient developed warts hands after receiving Gardasil. Medical attention was sought. The patient's warts hands persisted. VAERS ID: 300862-1 daughter began have facial (flat) warts her face and chest after the 2nd dose Gardasil. There are many warts her face and chest least more. She has never had this problem before receiving the vaccine. She was treated for warts her Doctor and now has been referred Dermatology. She has not recovered yet. VAERS ID: 288998-116 The possibility that Gardasil could make HPV infections worse very serious, and matter concern with both critics the vaccine and the FDA. background document produced the FDA's VRBPAC May 2006 states: There were two important concerns that were identified during the course the efficacy review this BLA [biologics license application]. One was the potential for Gardasil enhance disease among subgroup subjects who had evidence persistent infection with vaccine-relevant HPV types baseline. The other concern was the observations CIN 2/3 [cervical intraepithelial neoplasia, abnormal cell changes moderate stage] worse cases due HPV types not contained the vaccine. These cases disease due other HPV types have the potential counter the efficacy results Gardasil for the HPV types contained the vaccine The results exploratory subgroup analyses suggested concern that subjects who were positive for the vaccine-relevant HPV types had greater number CIN 2/3 worse cases. chart the committee's report revealed that efficacy subjects already exposed relevant HPV types had observed efficacy rate -44.6%. The disturbing efficacy rate raises questions who should receiving the vaccine, and why the FDA allows Gardasil administered without prescreening for HPV. The outcomes that can result from pre-exposure are disconcerting and deserve far more attention. possible that the FDAs efficacy considerations for subjects already exposed relevant HPV types manifesting itself the vaccine application review process. The FDA denied Merck's application expand marketing Gardasil women ages through June 25, 2008. The FDA notified Merck letter that there were issues that precluded approval the companys plans.18 The FDA refused Judicial Watchs June 26, 2008 request for copy the letter Merck, stating that the letter may made available under the provisions the FOIA. Judicial Watch immediately filed FOIA request for the letter. News media reporting the FDA denial Mercks plans stated that the agency had specific questions regarding Gardasil's effectiveness this older age group. These outstanding questions appear parallel the VRBPAC observations May 2006 (above). Merck also failed win approval from the FDA expand the Gardasil vaccine include additional strains HPV. Merck has reportedly now dropped all plans expand the vaccine.19 additional testing report shows that Merck tested Gardasil against aluminum-containing placebo. While most placebos are saline based, the FDA allowed Merck use placebo with undisclosed amount aluminum it. Gardasil itself contains 225 mcg aluminum. Aluminum can cause many serious problems including temporary and permanent nerve damage. Using reactive aluminum-containing placebo instead non-reactive saline base can make vaccines seem safer than they may actually be. While Merck has repeatedly stated that Gardasil comparable safety rate with the placebo, the placebo itself responsible for adverse effects then more difficult ascertain the vaccines safety. Mercks testing report shows charts clinical tests, and compares Gardasil with the aluminum-containing placebo. The table below the reports documentation all-cause common adverse effects20: All-cause Common Systemic Adverse Experiences GARDASIL Placebo Adverse Experience Days 5088) 3790) Postvaccination) Pyrexia 13.0 11.2 Nausea 6.7 6.6 Nasopharyngitis 6.4 6.4 Dizziness 4.0 3.7 Diarrhea 3.6 3.5 Vomiting 2.4 1.9 Myalgia 2.0 2.0 Cough 2.0 1.5 Toothache 1.5 1.4 Upper respiratory tract infection 1.5 1.5 Malaise 1.4 1.2 Arthralgia 1.2 0.9 Insomnia 1.2 0.9 Nasal congestion 1.1 0.9 true that the adverse reaction rates are comparable most the tests, but since the vaccine being tested against reactive, potentially harmful substance, the numbers may overstate the vaccines safety and understate its adverse side-effects. There only one table the entire report that compares the vaccine not only with the aluminum-containing placebo but also with one that saline based:21 Postdose Evaluation Injection-site Adverse Experiences Vaccine occurrence) Aluminum-Containing Placebo occurrence) Saline Placebo occurrence) Adverse Experience Post-dose Post-dose Post-dose Post Any Dose Post-dose Post-dose Post-dose Post Any Dose Post-dose Post-dose Post-dose Post Any Dose Pain Mild/Moderate Severe 63.4 62.5 0.9 60.7 59.7 1.0 62.7 61.2 1.5 83.9 81.1 2.8 57.0 56.6 0.4 47.8 47.3 0.5 49.5 48.9 0.6 75.4 74.1 1.3 33.7 33.3 0.3 20.3 20.3 0.0 27.3 27.0 0.3 48.6 48.0 0.6 Swelling*Mild/Moderate Severe 10.2 9.6 0.6 12.8 11.9 0.8 15.1 14.3 0.8 25.4 23.3 2.0 8.2 8.0 0.2 7.5 7.2 0.3 7.6 7.3 0.2 15.8 15.2 0.6 4.4 4.4 0.0 3.0 3.0 0.0 3.3 3.3 0.0 7.3 7.3 0.0 Erythema* Mild/Moderate Severe 9.2 9.0 0.2 12.1 11.7 0.3 14.7 14.3 0.4 24.7 23.7 0.9 9.8 9.5 0.3 8.4 8.3 0.1 8.9 8.8 0.1 18.4 18.0 0.4 7.3 7.3 0.0 5.3 5.3 0.0 5.7 5.7 0.0 12.1 12.1 0.0 *Intensity swelling and erythema was measured size (inches): Mild 1; Moderate 2; Severe This chart only records adverse experiences injection site and therefore does not shed much light the overall safety and effectiveness the vaccine. However, there are profound differences between the numbers adverse effects Gardasil and the saline placebo. Again, one can see that the numbers are similar between the vaccine and the aluminum placebo, but the saline-based placebo has far fewer reported adverse effects. The chart shows that while 83.9% patients experienced pain after injection with Gardasil, and 75.4% after receiving the aluminum-based placebo, only 48.6% patients experienced pain when receiving the saline-based placebo. The chart shows 25.4% people experienced swelling after receiving Gardasil, and 15.8% did after receiving the aluminum placebo. Only 7.3% patients receiving the saline placebo experienced swelling. The significant differences between the saline placebo and the vaccine raise questions how Merck's use aluminum-containing placebo may have affected the safety trials. The National Vaccine Information Center reports that A reactive placebo can artificially increase the appearance safety experimental drug vaccine clinical trial, adding that although aluminum adjuvants have been used vaccines for decades, they were never tested for safety clinical trials.23 difficult draw accurate conclusion from Merck's data, raising questions about Gardasil vaccine safety. Gardasil was approved large part due the unanimous vote support received from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 2006. VRBPAC special advisory panel created the FDA evaluate new biological material, including vaccines. While the FDA not required approve drugs that are recommended the committee, they usually do. The meeting took place May 18, 2006, and the primary speakers were Merck representatives Dr. Eliav Barr and Dr. Patrick Brill-Edwards. Merck was required submit numerous reports and documentation trial procedures the FDA both before and after the meeting took place, but the statements Merck's representatives paint far more optimistic picture the vaccine than their own reports justify. Dr. Patrick Brill-Edwards, Mercks Director Worldwide Vaccines Regulatory Affairs, was the main speaker the meeting. his opening statement said Merck proposed that studying cancer itself isn't feasible, because takes too long and disadvantages too many women.24 Merck scientists not only did not bother study cancer, they not even know whether their own vaccine carcinogenic. report the FDA testing protocol, Merck wrote that Gardasil has not been evaluated for the potential cause carcinogenicity genotoxicity.25 One would think that any cancer vaccine that has been approved the FDA ought least not cause cancer. Given that Gardasil works causing spontaneous reactions and cell mutation, its potential cause cancer certainly matter that warrants further study. Dr. Brill-Edwards following statements hardly build confidence. claimed that Merck had examined, how the vaccine interacts with other common adolescent vaccines,26 even though according their own documents Merck tested Gardasil only concomitantly with the Hepatitis vaccine. There are numerous vaccines that are commonly given adolescents, including booster shots for measles, mumps and rubella, Hepatitis shots, and Menactra, vaccine prevent meningitis. The Menactra vaccine has been shown react badly when given with Gardasil. VAERS reports from July 2007 March 2008 contain 220 cases adverse effects when Gardasil and Menactra were administered the same time. The most common symptoms were fainting, nausea, and dizziness but other girls suffered from pyrexia, convulsions, seizures, spontaneous abortions, and Guillain-Barre Syndrome. Even mild reactions occasionally led serious cases, some girls suffered severe injuries from falling while dizzy unconscious. Below are excerpts from VAERS documenting adverse reactions after receiving Gardasil and Menactra: 16-year-old female patient had received intramuscular, first dose injection Menactra and intramuscular, first dose injection Human Papillomavirus Recombinant Vaccine. The patient experienced numbness and tingling her feet and hands The patient was referred and examined neurologist. During that exam, she was found have weakened severely. She was admitted pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed lumbar puncture. VAERS ID: 262735-2 17-year-old female with medical history and drug allergies was vaccinated with 0.5mL dose Gardasil. Concomitant vaccinations included Menactra and Dtap. The patient fainted, fell off the table, hit her head the ground, and had seizure. The patient also had cut the bridge her nose and gums. The patient went the emergency room The physician thought the seizure was due head trauma. VAERS ID: 306241-1 sometimes difficult ascertain whether adverse events are directly linked vaccinations, but the case injuries caused fainting directly after receiving Gardasil the link fairly obvious. Whether fainting was caused Menactra Gardasil combination, merits further study. Particularly since many schools and colleges require students receive these vaccinations order attend classes, seems only logical that Merck would have tested Gardasil with these vaccines, or, failing that, that the FDA would have insisted it. During the VRBPAC meeting, Dr. Brill-Edwards said that Merck knew that this vaccine would given women child-bearing potential, right from the beginning, set program that would really evaluate great detail, all the pregnancy outcomes that would occur and subject receive Gardasil.27 was Mercks intent examine the vaccine pregnant women, interesting that its briefing the FDA Merck reported, It not known whether Gardasil can cause fetal harm when administered pregnant woman.28 They reported that 27% pregnant women experienced adverse reactions, and the VAERS reports show cases miscarriages, spontaneous abortions, often within weeks receiving the Gardasil vaccine. one VAERS report, 17-year-old girl with medical history received the Gardasil vaccine July 31, 2007 and then had spontaneous abortion August 14, only two weeks afterwards.29 Below excerpt taken from another case spontaneous abortion, occurring less than two weeks after the patient received her second dose Gardasil: The patient was vaccinated with second dose HPV and had positive pregnancy test the next day. The patient presented the physicians office 09-APR-2007 with vaginal bleeding and pelvic ultrasound determined that she was suffering spontaneous abortion The patient was admitted the hospital with severe vaginal hemorrhaging and underwent emergency dilation and curettage procedure The physician considered spontaneous abortion significantly disabling and life threatening. VAERS ID: 277166-1 (S)30 Gardasil's campaign does state that the vaccine should not given pregnant women, but does not mention women who are breastfeeding, even though Mercks June 2006 briefing the FDA says, It not known whether vaccine antigens antibodies induced the vaccine are excreted human milk, and A higher number breastfeeding infants (n=6) whose mothers received Gardasil had acute respiratory illnesses within days.31 This number three times higher than that the placebo group. this time, unknown whether Gardasil may have long term effects fertility. Since the vaccine was only released 2006, could years before anyone knows its long term effects. Mercks only fertility tests were conducted rats. Gardasil administered female rats dose 120 mcg total protein, which corresponds approximately 300-fold excess relative the projected human dose, had effects mating performance, fertility, embryonic/fetal survival adverse effects mating, fertility, pregnancy, parturition, lactation, embryo-fetal pre-and postweaning development were observed. There were vaccine-related fetal malformations addition, there were treatment-related effects developmental signs, behavior, reproductive performance, fertility the offspring.32 There are several problems with this test. First, still sheds light possible longterm side effects, the rats were monitored only through single fertility cycle. Second, and perhaps more importantly, Gardasil modeled after and made from the human papillomavirus. While there are other strains the papillomavirus that effect animals, only humans can carry the human strains. Since the Gardasil vaccine was designed react only with certain strains the human papillomavirus, any test involving rats inconclusive. Merck acknowledged that, not known whether Gardasil can cause fetal harm when administered pregnant women can affect reproductive capacity.33 Merck recommends that pregnant women not receive the vaccine. Dr. Barr told the VRBPAC members that the Gardasil vaccine would help save money, HPV infection very frequent, women have screened frequently, and that translates approximately million Pap tests every year These lesions and screening programs are very expensive. They cost over four billion dollars year the U.S.34 While Dr, Barr implies the Gardasil vaccine would save money, patients who receive the vaccine should still have Pap screenings regularly, the vaccine would not have any effect Pap screening costs. Gardasil does not even eliminate the need for HPV screenings. Mercks website states that the Gardasil vaccine does not prevent all types cervical cancer, it's important continue routine cervical cancer screenings. Gardasil will not protect against diseases caused other HPV types.35 Given the fact that women must still receive regular screenings, there would significant benefit from financial standpoint. This especially true since Gardasil the most expensive vaccine ever recommended the FDA. administered three doses given over the course six months, and each dose $120, meaning the total cost for receiving the vaccine $360. Gardasil may have benefits, but lessened costs for cervical cancer screening would not seem among them. Gardasil and the American Marketplace Even with state and federal program subsidies help pay for Gardasil, the drug extraordinarily expensive. article The New York Times estimated that making Gardasil mandatory would almost double the cost vaccine programs. North Carolina, for instance, spends $11 million annually provide every child with seven vaccines. Gardasil alone would probably cost least another $10 million.36 Gardasil expensive that some doctors cannot even afford stock the vaccine. While some insurance companies cover part the costs for the vaccine for females aged 26, doctors are not reimbursed until after vaccines are administered. addition having pay for the initial costs out their own pockets, practitioners must also pay have the vaccines properly shipped and stored, additional cost for which they are not reimbursed. Doctors actually lose money when they choose stock the Gardasil vaccine, and many decide that not worth the cost. For uninsured females, state and federal programs cover all most the cost Gardasil. The New York Times reported June 2006 that the decision make Gardasil federally recommended vaccine all but commits the federal government spend much billion alone program buy the vaccine for the nation's poorest girls.37 John Schiller, investigator for the National Cancer Institute, said that This vaccine will more expensive than all other childhood vaccines put together.38 Unavoidably, much these costs will ultimately passed taxpayers. estimated 55% children receive vaccines that are paid for state and federal government, and Medicaid alone provides vaccines for approximately 40% children under the age 19. While some states strive cover all vaccines for children, rising costs make challenging. States such Alaska, North Dakota, and North Carolina have seen the price vaccinating child double the past few years. The New York Times reports that 1980 cost about $23, $59 adjusted for inflation, for the seven shots and four oral doses needed immunize child.39 Now, child receives all recommended vaccines the cost would more than $1,600. 2000, Medicaid spent $500 million vaccines and immunizations. Now the budget exceeds $2.5 billion.40 Are mandatory vaccines becoming too expensive for the government and ultimately the American taxpayer afford? Gardasils high cost important government spending issue, especially many politicians are trying make mandatory vaccine for all young girls. also important remember that the vaccines safety and overall effectiveness are unknown. far long-term effectiveness concerned, Merck told the FDA 2006: Efficacy was durable through least 2.5 years postvaccination with respect infection and disease caused HPV HPV 11, and HPV 18, and least 3.5 years postvaccination with respect infection and disease caused HPV Because these subjects completed their vaccinations 2003, the longer-term duration efficacy the vaccine will known well advance the time needed implement booster vaccinations.41 seems ill-advised spend millions even billions dollars programs implement vaccine that may only effective for three four years. Even one supposes that the vaccine lasts for five years, young girl who vaccinated the age ten would need numerous booster shots. she lived the age 75, she would need twelve booster shots and $120 shot, the total cost vaccinating one person would $1800. vaccinate every and year old girl the United States today, would cost around $1.5 billion. protect only those girls for lifetime, the cost would $7.7 billion. Even one just estimated the cost initial vaccination for and year old girls, ten years the United States would spend least billion limited health care dollars, before calculating the costs possible booster shots.42 This seems too much money spend vaccine when little known about its efficacy, safety, and effects fertility. Safe and Effective? There proof that Gardasil will prevent about half the high-grade precursors cancer, but half will still occur. Hundreds thousands women who are vaccinated with Gardasil and get yearly Pap testing will still get high-grade dysplasia (cell abnormalities).43 Gardasil has been shown prevent precancerous lesions, but has been impossible ascertain whether will actually prevent cancer because the testing period has been short. While young women occasionally get cervical cancer, far more common women their late forties. The average age cervical cancer patient forty-eight years. Keeping this mind, could easily decades before anyone truly knows the Gardasil vaccine prevents cervical cancer. The most that can accurately said this point that Gardasil has been shown help prevent precancerous lesions, but its extremely aggressive advertising and political lobbying campaigns Merck states that "Gardasil does more than help prevent cervical cancer. Gardasil the only cervical cancer vaccine that helps protect against human papillomavirus (HPV) types that cause 70% cervical cancer cases."44 The FDA only speculates that, believed that prevention cervical precancerous lesions highly likely result the prevention those cancers.45 one knows the vaccine prevents cancer, for how long, even whether safe. When the FDA fast-tracked Gardasil, was with the condition that Merck must conduct safety surveillance study: The study will include approximately 44,000 vaccinated subjects who will followed for days for assessment general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also followed for months subsequent vaccination for new autoimmune disorders, rheumatic conditions, thyroiditis. Also, sufficient number children 11-12 years age will studied permit analysis safety outcomes. The study will completed June 30, 2009. The final study report will submitted September 30, 2009.46 Even though Gardasil will not fully tested for safety until 2009, physicians are already pushing routine, harmless vaccine. Mercks aggressive advertisement campaign tells young girls that their lives could one less affected cervical cancer and that, Its your turn help guard against cervical cancer. Mercks lobbying campaign encourage state lawmakers mandate Gardasil was aggressive that caused major controversy among concerned parents nationwide. February 2007, due pressure from concerned parents and organizations and unfavorable media attention Merck pledged least stop its lobbying campaign make Gardasil mandatory vaccine for sixth-grade girls. But Mercks intensive advertising campaign continues. Those who push administer Gardasil three years before its safety testing complete may placing young girls and women risk. VAERS Reports The VAERS reports have shown some the results Mercks experiment the public. VAERS may submitted anyone, including physicians, nurses, parents, and patients. Because the open submission process for VAERS, Merck and FDA officials discount many the reports coincidental and not related the vaccine. The fact remains, however, that medical professionals, patients their family members thought there was enough connection submit reports. Judicial Watch filed request obtain all VAERS reports concerning Gardasil May 2007. The most recent reports were released the FDA June 10, 2008. While the past Judicial Watch had received VAERS reports smaller groups, this production was the first time all them had been collected and analyzed together. total, 8,864 reports have been filed. The VAERS reports document that there have been reports Guillain-Barre Syndrome among girls who received the Gardasil vaccine. Guillain-Barre Syndrome potentially devastating illness that attacks the nervous system and can result paralysis. Even though some these cases had onset dates within days receiving Gardasil, the CDC stated that, After careful review the GBS reports received VAERS, many appear have insufficient clinical data. Because GBS occurs rate 1-2/100,000 person years during the second decade life, likely that some cases will occur after vaccination but will not due vaccination.47 However, even taking into consideration coincidental cases, the VAERS reports show that the average onset date Guillain-Barre Syndrome Gardasil-related cases was only days after receiving the vaccine. Twenty-nine the thirty-eight cases have onset dates two weeks less, and ten girls developed Guillain-Barre Syndrome within twenty-four hours. Below are excerpts from the VAERS reports: Information has been received concerning 16-year-old female who 16-APR-2007 was vaccinated with dose Gardasil. Since day post-injection, the patient had progressive bilateral leg numbness and weakness and motor weakness. VAERS ID: 277814-1 Information has been received concerning approximately 19-year-old female who was vaccinated with first dose Gardasil. Subsequently, the patient was diagnosed with Guillain-Barre Syndrome and was hospitalized. The patients Guillain-Barre Syndrome persisted Guillain-Barre Syndrome was considered disabling and immediately life-threatening. VAERS ID: 296713-1 (S) [Patient] admitted hospital with chief complaint ascending weakness bilaterally, upper and lower extremities Severe form Guillain-Barre syndrome after HPV vaccine Respiratory failure with prolonged mechanical ventilation and tracheostomy tube Placement vital capacity deteriorated day able move only jaw and eyes. VAERS ID: 268143-1 (S) These cases document apparent extremely serious side effects for vaccine that being marketed necessary and routine. They certainly warrant far more investigation and examination than they have evidently received. The VAERS reports also reveal many young girls and women have died after receiving the vaccine. While the deaths are quite possibly not linked the vaccine, there report perfectly healthy 17-year-old girl dying suddenly and alone, two days after receiving her third dose the vaccine.48 She was birth control, was another young woman who also died two days after receiving Gardasil: Information has been received concerning 22-year-old female patient with pertinent medical history drug allergies who May 2007 was vaccinated with 0.5ml dose Gardasil Concomitant therapy included hormonal contraceptives (unspecified). May 2007, the patient died suddenly. The cause death was unknown. VAERS ID: 287888-1 (D). the eighteen deaths, eleven them occurred less than week after receiving the vaccine, and seven less than two days. The most common diagnosed cause was blood clotting, seen from the reports below: Information has been received concerning female patient who was vaccinated with dose Gardasil. The [physicians assistant] reported that the patient died blood clot hours after getting the Gardasil vaccine. VAERS ID: 275990-1 (D) [19 year old female] given Gardasil vaccine dose [on] 3/12/07 Collapsed and died 3/26/07 autopsy done Medical Center states from Death Certificate COD [cause death] sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle small left ventricle well large blood clots within both the right atrium right ventricle. VAERS ID: 275438-1 (D) The fact that blood clotting responsible for almost fourth all deaths involving Gardasil extremely concerning, especially since most birth control drugs increase ones risk developing blood clots. Many girls and young women who receive Gardasil will already taking birth control the time they are vaccinated, and therefore the possibility that Gardasil may add risk blood clots serious issue that deserves attention. addition the four cases death from blood clots, there was also one reported death due myocarditis, which inflammation the heart, well one death from arrhythmia and one death from meningitis. Both the arrhythmia and meningitis cases occurred months after the patients received the Gardasil vaccine; the myocarditis death occurred six days after vaccination but was pre-existing condition. Even excluding these deaths though, there are still fourteen cases that occurred within three weeks receiving the vaccine. One was from anaphylactic shock: 11-year-old female was vaccinated within the past month approximately May 2007 with first dose Gardasil. Subsequently, days after vaccination the patient presented the physician from the hospital said that the death was due anaphylactic reaction Gardasil. VAERS ID: 280163-1 (D) The remaining deaths reported VAERS all have unknown causes; however, all but one occurred within three weeks receiving Gardasil, and six occurred within three days. Below are additional excerpts from deaths with apparent cause reported VAERS: 18-year-old female patient was vaccinated with the first dose Gardasil the evening the same day she was found unconscious (or liveless) [sic] the mother. Resuscitation was performed the emergency doctor but was unsuccessful, i.e. the patient finally died The cause death this patient remains totally unclear. VAERS ID: 300741-1 (D). 19-year-old female with previous medical history reported, who 19-Sep-2007 was vaccinated with the 1st dose Gardasil the morning 12-Oct-2007, the patient was found dead her bed Contraception was stopped months before vaccination. reason for the death was detected autopsy. VAERS ID: 299377-1 (D) Information has been received from physicians assistant concerning 12-year-old female with reported medical history who approximately 15-Sep-2007 was vaccinated with Gardasil 06-OCT-2007 the patient died her sleep. further information was provided. VAERS ID: 297528-1 (D) Sudden unattended death [February 22, 2007] patient [17-year-old female with medical history known allergies] last seen office nurse only 2/20 for HPV The autopsy was negative for all findings. Scene indicated sudden death from collapse and fall. VAERS ID: 305606-1 (D) Information has been received from physician concerning 20-year-old female with medical history reported, who 01-APR-2008 was vaccinated with dose Gardasil. 05-APR-2008, the patient died four days after receiving Gardasil autopsy was performed which ruled out suicide and anything suspicious. The cause death currently unknown. VAERS ID: 310262-1 (D) Perhaps all these deaths are simply coincidence, but given the unknowns about Gardasil and its overall safety, far too important issue simply ignore. Mercks last wonder drug, Vioxx, was pulled from the market 2002, after estimated 88,000 140,000 adverse reactions were attributed it. Vioxx, like Gardasil, was fast-tracked the FDA 1999, without full safety testing and analysis period taking place. was anti-inflammatory drug designed relieve people suffering from arthritis, menstrual cramps, and acute pain. Merck voluntarily pulled Vioxx from the market after safety trial was stopped because, there was increased risk for serious cardiovascular events, such heart attacks and strokes.50 Vioxx was pulled after five years the market and after contributing 27,785 heart attacks and sudden cardiac deaths, addition other events, estimated the FDA.51 Analysts estimate that the Vioxx recall decreased Mercks stock value drastically, and could cost Merck anywhere from $20 billion. Less than two years after Merck suffered this severe blow, the company introduced Gardasil, the most expensive vaccine the market, and was approved the FDA. There are numerous critics the Gardasil vaccine, but perhaps the most important Dr. Diane Harper. Not only she specialist HPV, she also helped develop the Gardasil vaccine. television interview with CBS News May 2008, the doctor said that she viewed making the vaccination mandatory A real danger zone, adding: the vaccine has not been out long enough for have post-marketing surveillance really understand what all the potential side effects are going be.52 While Dr. Harper said she believes that the vaccine will beneficial the long run, she cautions: To put process place that says you must have this vaccine means that you must part big public experiment and cant that. cant have that until have more data.53 unacceptable mandate any vaccine without first testing for effectiveness, safety, and long-term side effects. The Gardasil vaccine may important step preventing cervical cancer, but step that may cause other harms. Analysis Gardasil advocates and supporters the FDAs fast-tracked approval the vaccine attacked Judicial Watchs 2007 publication VAERS records and reporting deaths well serious, life threatening reactions the vaccine. easy conclude that Merck, the FDA and their associates were not interested these government records being widely discussed and reported on. fact, Judicial Watch has copies FDA email revealing their frustration with Judicial Watchs work. Critiques Judicial Watchs 2007 reporting usually misrepresent the organizations efforts make government records public and offer that, Judicial Watch cant prove causality from the VAERS reports. Judicial Watch was not and not interested proving causality. Only science can that. And that why asked for more investigation the VAERS reports ensure there was causality between Gardasil and the serious reported adverse reactions. What seek transparency the workings government that citizens can make informed decisions. This report will, doubt, renew attacks from supporters Gardasil. There is, however, good reason for public skepticism concerning the rush mandate schoolgirls being vaccinated. While the word cancer invokes wide range emotions that can both influence and motivate parents, lawmakers, public health officials, pharmaceutical firms and lobbyists, important evaluate the facts against the claims both slick marketing and sophisticated political pressure campaigns. Canadian epidemiologist, Dr. Abby Lippman McGill University, raised similar important concerns over HPV vaccinations the August 28, 2007 edition the Canadian Medical Association Journal. Dr. Lippman wrote: A careful review the literature, including that submitted the manufacturer with its application for approval Gardasil reveals sufficient number unanswered questions lead conclude that universal immunization program aimed girls and women Canada is, this time, premature and could possibly have unintended negative consequences for individuals and for society whole.54 Women have been assured experts and authorities before about the safety and efficacy various medicines and procedures. Recent history replete with horrific examples misplaced public trust: Thalidomide; the Dalkon Shield; hormone replacement therapy; and diethylstilbestrol (DES). Gardasil advocates use patronizing tone critiquing the doctors, scientists, public policy groups, parents and young women that question the vaccines government-reported adverse events and side effects. Those harboring some skepticism about enormous public health experiment being conducted schoolgirls and young women are supposed find consolation assurances that the vaccine being closely monitored. The same authorities offering the assurances ridicule VAERS reports unreliable cold consolation, indeed. The top causes death women the United States are: heart disease, stroke, lung cancer, respiratory diseases, Alzheimers, breast cancer, diabetes, various accidents, flu/pneumonia, and 10) colon cancer.55 mentioned above, approximately 3,700 American women die cervical cancer each year small fraction the number women who die from colon cancer (10th leading cause death). The death from cancer anyone tragic, and work prevent such deaths must continue pursued aggressively especially cases where early detection and treatment offer much hope. Despite these regrettable 3,700 deaths, when one examines the totality the nations health system, there epidemic domestic public health crisis concerning either HPV infection cervical cancer. HPV infection and cervical cancer should not conflated: cervical cancer will not develop most women who are infected with even high-risk strain HPV.56 Based marketing and lobbying campaigns, well the majority health news media reporting, unlikely that parents pre-teens and young women are aware these important distinctions. Conclusions Gardasil such new drug that impossible say this point how beneficial may be. Most scientists, including Dr. Diane Harper, agree that booster shots will needed, and guess that the original vaccine will effective for least five years. important emphasize that regardless how effective Gardasil is, does not protect against all HPV strains and will never eliminate the need for regular testing and Pap screening. Gardasils safety for the general public serious concern. While drug ever completely risk-free, careful analysis must made whether the benefits are worth the costs. HPV, though potentially devastating, quite often completely harmless. Most HPV infections, even ones caused high-risk strains, away their own and never develop into cancer. Even when they do, most cases takes years for cancer occur and easily preventable long the HPV infection detected early. Even without Gardasil, cervical cancer deaths have decreased drastically the past several decades. The American Cancer Society estimates that deaths from cervical cancer declined 74% between 1955 and 1992, and that the rate continues decrease about each year. Also, most cases occur women their forties.57 With these statistics mind, one might ask whether Gardasil vaccination absolutely necessary, especially for children. this point time, not know will prevent cancer, whether will have unforeseen consequences. The American public must ask themselves Gardasil really worth the risk. Fast-tracking drugs and vaccines before their safety has been fully evaluated unethical and dangerous, and until more tests have been completed Gardasil vaccination mandates should established. Gardasil has not been tested thoroughly enough know whether will safe effective the long term. Even shown that the Gardasil vaccine effective, still unknown how long the vaccine lasts there will need for booster shots. Regardless its potential help prevent HPV and cancer, Gardasil should never administered without prescreening for HPV since has the potential make existing cases worsen. important that people remember that this vaccine will not eliminate the need for regular Pap screening. vaccine 100% effective, and Gardasil designed protect against only four strands HPV. While Gardasil may important medical advance, unwise compromise the health and safety the American public, especially children, mandating marketing before sufficient tests are concluded. Endnotes See VAERS Report 282747-1 (D); Reporting June 25, 2007, that physician attending conference who mentioned that additional two patients vaccinated with Gardasil subsequently died. Attempts reportedly being made obtain additional information. VAERS reports available the Internet at: . See Tab 003. National Conference State Legislatures, HPV Vaccine: State Legislation, Updated June 2008, , Accessed June 12, 2008. American Social Health Association, HPV, Human Papillomavirus: What Women Should Know, , Accessed June 18, 2008. 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. The New England Journal Medicine, Quadrivalent Vaccine against Human Papillomavirus Prevent High-Grade Cervical Lesions, Vol. 356, No. 19, May 10, 2007. National Cancer Institute, Human Papillomaviruses and Cancer, http://www.cancer.gov/ cancertopics/factsheet/Risk/HPV Accessed May 22, 2008. American Cancer Society, What Are the Key Statistics About Cervical Cancer?, , Accessed June 18, 2008. American Social Health Association, HPV, Human Papillomavirus: What Women Should Know. Food and Drug Administration, Product Approval Information-Licensing Action: Gardasil Questions and Answers, , accessed June 2008. The New England Journal Medicine, Quadrivalent Vaccine against Human Papillomavirus Prevent High-Grade Cervical Lesions. Dr. Jesse Goodman, quoted The New York Times, U.S. Approves Use Vaccine for Cervical Cancer, June 2006. See Tab Merck Co., Inc., GARDASIL Quadrivalent Human Papillomavirus (Types 11, 16, 18) Recombinant Vaccine, June 2006, 11. The New England Journal Medicine, Quadrivalent Vaccine against Human Papillomavirus Prevent High-Grade Cervical Lesions. See Tab Food and Drug Administration, VAERS Line List ReportVaccine Type: HPV, HPV4, report ran June 10, 2008. Ibid. 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. Reuters, Mercks Gardasil Not Cleared for Older Women, June 25, 2006, , Accessed June 26, 2008. Ibid. See Tab Ibid, National Vaccine Information Center, Merck's Gardasil Vaccine Not Proven Safe for Little Girls, June 27, 2006, , Accessed June 24, 2008. See Tab Dr. Patrick Brill-Edwards and Dr. Eliav Barr, Food and Drug Administration Center for Biologics Evaluation and Research, Vaccines and Related Biological Products Advisory Committee: Meeting, May 18, 2006, 13. See Tab Dr. Patrick Brill-Edwards and Dr. Eliav Barr, Food and Drug Administration Center for Biologics Evaluation and Research, Vaccines and Related Biological Products Advisory Committee: Meeting, May 18, 2006, 13. See Tab See Tab 12. Ibid, 12. See Tab See Tab VAERS 290582-1. See Tab See TabA, 10. See TabA, 9. Ibid, See Tab Merck Co., Inc., Important Information About Gardasil , Accessed May 21, 2008. The New York Times, U.S. Approves Use Vaccine for Cervical Cancer, June 2006. The New York Times, Panel Unanimously Recommends Cervical Cancer Vaccine for Girls and Up, June 30, 2006, http://www.nytimes.com/2006/06/30/health/30vaccine.html? Accessed June 27, 2008. Ibid. The New York Times, Rising Costs Make Doctors Balk Giving Vaccines, March 24, 2007, Accessed June 12, 2008. Merck Co., Inc., Important Information About Gardasil , accessed May 21, 2008. Food and Drug Administration, Gardasil Questions and Answers, , accessed June 2008. See Tab FDA Department Health Human Services, Patent Approval Notification Letter, June 2006, Center for Disease Control, HPV: Gardasil and GBS, August 15, 2007, , accessed June 2008. See Tab VAERS ID: 305606-1 Ibid. Food and Drug Administration, Vioxx (rofecoxib) Questions and Answers, September 30, 2004, , accessed June 10, 2008. Consumer Affairs, FDA Estimates Vioxx Caused 27,785 Deaths, November 2004, Accessed June 24, 2008. Dr. Diane Harper, seen CBS Potential Side Effects HPV Vaccine Questioned, , May 2008. Ibid. Human papillomavirus, vaccines and womens health: questions and cautions, Abby Lippman, PhD, Ryan Melnychuk, PhD, Carolyn Shimmin, BJ, and Madeline Boscoe, DU, Canadian Medical Association Journal, August 28, 2007, page 484, , Accessed June 27, 2008. Center for Disease Control, United States Health 2007, with Chartbook Trends the Health Americans, 567 pp. (PHS) 2007-1232; , Accessed June 20, 2008. Public Health Agency Canada. What everyone should know about human papillomavirus (HPV): questions and answers. Available: . Accessed June 20, 2008. American Cancer Society, What Are the Key Statistics About Cervical Cancer?