Top HPV-Vaccine Researchers Join Those Advising Caution in HPV-Vaccines Gardasil and Cervarix Immunization
Dr. Diane Harper was a lead researcher in the development of the HPV vaccine. Her HPV-vaccine trial papers were amongst the first I found when I started researching Gardasil. In 2004 Dr. Harper was excited about the the possibilities for the HPV-vaccine. By March, 2007 she had become an out spoken, and often quoted critic of Merck’s HPV-vaccine Gardasil and how it was being marketed to the American public. She has expressed that neither Merck, CDC nor the FDA have been forthright about the trials prior to vaccine licensure of Gardasil June 2006.
Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine, designed to prevent cervical cancer and genital warts, is safe to give to young girls. Merck and the FDA do not reveal in public documents exactly how many 11 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.
The study consisted of 2,392 young women. 36 percent were disqualified primarily because they had detectable HPV markers before the trial. The study was selected for women who showed some sort of robust natural immunity that kept them from expressing the HPV markers. 859 were excluded from the final data analysis for technical reasons and the vast majority were found to be infected with HPV-16 before getting the vaccine.
Of 1,533 women who remained, half were given the vaccine and half the placebo shot. The placebo used contained a potentially reactive aluminum and a non-reactive saline solution. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial.
Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.
Fifteen women in the Gardasil group and 16 in the placebo group gave birth to babies with abnormalities. Five of the babies were conceived by women 1 month after they received the vaccine. The rest were conceived by women after 1 month of injection with Gardasil. In the same report, Gardasil was also found to cause an increase in abnormal/precancerous cells in the cervix. It doesn’t take rocket science to intelligently translate that into an increased risk for cervical cancer. Contradictory to Merck’s ad campaign of “one less”, girls taking the vaccines are actually at an increased risk of being one more in the cervical cancer statistics. Of those who received the placebo shot, 41 women became infected with HPV-16, and nine of them had precancerous cervical growths.
Then the study used a cancer detection method which is known to be inaccurate, with a rate of false negative test results that ranges from 1 percent to 93 percent, despite the fact that it is the only test currently available in the United States to screen women for signs of cervical cancer. (A false negative result means that women who have cervical cancer or precancerous tissues are not being identified when they have a Pap smear.)”
The women in this study were only monitored for HPV infection if they show a positive Pap smear. But since even the CDC recognizes that the Pap test produces a wide range of false negative results, the HPV study’s Pap test is so unreliable that the rest of the study is raises much suspicion.
A positive result was defined as any PCR signal that exceeded the background PCR level associated with an HPV-negative sample of human DNA. This is a risky protocol because PCR tests are plagued with false positive reactions (a positive signal that is not a true detection of the target). Since the authors show no data or reference to data on a secondary test that confirms the gene sequence of a positive signal, they cannot conclude that they are measuring HPV.”
According to Merck’s product insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.
Dr. Diane Harper, a lead researcher in the development of the HPV vaccine has studied the Human papillomavirus for over 20 years. She states that giving this vaccine to girls as young as 11 years old is a “great big public health experiment” and that it has NOT been tested for effectiveness for them. She also says that it will not protect girls at all that are as young as nine years old.
Harper feels the ideal way to vaccinate women is to offer it at 18 years of age. She says these women should be screened for HPV. If the test results are negative then they should schedule the 3 shot series. She admits that if the test comes back positive there is truly no understanding of how to medically respond to that.
“The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most.” Harper says. “This vaccine should not be mandated for 11-year-old girls,” she reiterated. “It’s not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.” Clearly if it has not been tested for efficacy in 11 year old girls, it is neglectful and wrong for CDC and politicians to even suggest [much less recommend] the vaccine to be effective or safe for nine year old girls. Physicians should be careful not to follow in such disgrace by administering the vaccine to these young girls.
In the New Your Times article Dr. Harper said, “Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.
“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”
In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance.
“In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said. “Those getting it early should be the ones who really want it and willing to accept the risk.”
“Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer,” says Harper.
Angela Raffle, a specialist in cervical cancer screening with the National Health Service in Britain said “There is no need to rush… If we do this quickly and badly, we could cause more deaths,” from side effects, for example, or from giving girls false security that they are protected for life and no longer need to be screened.
Merck has not been able to prevent cancer. Not in the trials and not now. Gardasil is not 100% effective against HPV. Harper reminds us that it is only 100% effective against two types of HPV. Those would be the two high risk types [HPV-16 and HPV-18]. The other two [HPV-6 and HPV-11] are low risk and have not been associated with cervical cancer.
In a 1998, study on the Transmission of Cervical Cancer-Associated Human Papilloma Viruses from Mother to Child, posted on the Interviology, Karger.com web site, the authors stated that: “ …HPV have been detected in asymptomatic women, infants and children. Several studies have demonstrated that infants can acquire high-risk HPV infections from their mothers at birth. Thus, the traditional view that cervical-cancer associated HPV infections are primarily sexually transmitted needs to be re-assessed. …the role of mother to child transmission of cancer-associated HPVs may need to be investigated further. These facts are pertinent to those developing prophylactic vaccines to prevent high-risk HPV infections and cervical carcinoma.”
Exposure of HPV to infants and children prior to inoculation; raising concern that the vaccine will be rendered ineffective. In a September 12, 2008 news release, the FDA stated that: “There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.” If a young girl already has HPV-16 and HPV-18 markers before inoculation, the vaccine will not protect her from infection of those strains. The only way to test for the presence of HPV is to conduct a vaginal swab, which is inappropriate to do with young girls. Merck assumed that because older girls did not show up with HPV markers after inoculation, the young girls (as young as 9 years old) would be protected as well.
Sound science does not run on assumptions.
Clearly, three years of studying the safety and efficacy of a vaccine against a cancer that takes decades to develop is not long enough. There is no science in fast tracking trials or a vaccine for cervical cancer and then presuming safety and efficacy. The third phase of the trial was not even completed before the vaccine was licensed. “There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” says Barbara Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing LESS than one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.“
Starting in July 2006, one month after Gardasil’s June, 2006, FDA approval, the number of of adverse effects to the CDC and FDA compiled database reports continued to escalate coming from 43 states by December 2006. Below are some of those reported reactions listed on the VAERS database experienced by girls given only GARDASIL [no other vaccines administered at appointment].
- the patient experienced extreme pain at the injection site. The onset of the pain was immediate
- 1 hr after vaccination, pt reported to feel dizzy, weak, vision went black for a few seconds, got pale with purple lips x 1/2hr. Felt better after drinking OJ. Then got temp 101F and chills x 1 day.
- Vaccine given after physical. Pt fainted, vasovagal, hit head on carpeted cement floor. Loss of consciousness 1 min, had tonic posturing of right hand only some shaking.
- patient developed a rash and hives. It was reported that this was not an injection site rash. The patient presented to her physician’s office on 18 Aug 06 with hives all over her body.
- patient developed a swollen thumb and her palms became red and hot. The patient later developed a tightness in her chest. The patient was immediately taken to a physician (an allergist who was the mother’s employer) who immediately gave the patient a huge dose of cetirizine hydrochloride and acetaminophen as an intervention.
- experienced slurred speech
- patient experienced profuse nausea, vomiting, low grade fever and myalgia
- the patient fainted (this appeared to be common in the database after HPV injections)
- patient developed “flu-like symptoms”
- patient stated that “right after getting the shot” she experienced pain in the upper arm on and off throughout the day. She also stated that the pain”feels like she has a knife in her arm”.
The above are “notes” which were accompanied with other numerous listed symptoms for each individual such as:
- speech disorder
- influenza
- tremor
- abnormal thinking
- eyes with fixed upward gaze
- herpes
- herpes simplex
- hepatitis (type not specified)
- anorexia
- Gillian barre syndrome [five cases]
- abdominal pain
- grandmal seizures
- facial paralysis
According to Dr. Harper, while the VAERS database, at the time had only has 5-cases of Gillian Barre Syndrome listed, there were actually 40-cases within the first six months after Gardasil was approved by the FDA. These cases represent girls who received Gardasil along with the meningitis vaccine. Scientists admit that vaccines can trigger GBS and that they didn’t expect the numbers to be as high as they are in association with Gardasil.
The vaccine has raised serious questions over how to safeguard their children’s health for some. Phillip and Barbara Tetlock, both professors at the University of California at Berkeley, are asking whether Gardasil shots that their daughter, Jenny, received last year contributed to her illness, an extremely rare form of progressive paralysis that has left her bed bound and needing assistance to breathe at age 14.
Gardasil was only administered by itself or with Hepatitis B during the trials. Doctors administering Gardasil with any other vaccine is admittedly conducting experimentation. Researchers are now able to analyse what is happening with young girls vaccinated with Gardasil and one or more other vaccine(s), by examining the entries in the VAERS database.
Now, let’s go back to that question of why CDC and Merck would push to have this vaccine mandated.
To my prehaps cynical mind, the answer is Money.
Where is the the money coming from? Merck.
Where is it going to? Those advocating for a mandated HPV-vaccine policy.
Who’s pushing? Politicians…and then the money comes back full circle to MERCK —billions of dollars to the bottom line, increased dividends for stockholders.
In an August 19 2008, New York Times article, ‘Drug Makers’ Push Leads to Cancer Vaccines’ Rise’, ELISABETH ROSENTHAL, noted some of the market drivers Merck used to raise the awareness of Cervical cancer and of course, their HPV-Vaccine, Gardasil as a needed solution. Hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars in the USA. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.
“There was incredible pressure from industry and politics,” said Dr. Jon Abramson, a professor of pediatrics at Wake Forest Univeristy who was chairman of the committee of the CDC that recommended the vaccine for all girls once they reached 11 or 12.
“The vaccine is too new to be thinking about mandates”
Dr. Jon Abramson, a professor of infectious diseases
Wake Forest University Medical School and chairman of the CDC’s immunization practices committee.
“This big push is making people crazy — thinking they’re bad moms if they don’t get their kids vaccinated,” said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women’s Health Network. Canada will spend $300 million on a cervical cancer vaccine program. To further encourage vaccination on campus, Merck gave the American College Health Association with an unrestricted grant to train its officers to speak about the new vaccine and to create kits to discuss cervical cancer and promote the vaccine for college health services. The association now recommends the shot for all female college-age students, even though many in that group already have HPV, rendering the vaccine less useful.
Merck’s ‘Big Push” was being carried out on several fronts. In June, 2006, after Gardasil’s FDA approval, the CDC’s The Advisory Committee on Immunization Practices (ACIP) recommended the Merck HPV-vaccine as a school attendense requirement for girls. In September, 2006, Michigan was the first US state to propose a bill that would recommend the vaccine for girls registered in the public schools. Utimately, the Michigan legislature voted against manadating the Gardasil vaccine for school girls. Merck was down but not out they still had every expectation for Gardasil mandates from the state governments of Texas, Pennsyvania, Virginia, and Colorado.
The State of Virginia passed a bill requiring the vaccine for school entry taking effect in 2009The Washington Post reported on Saturday, March 3, 2007 that Virginia Gov. Timothy M. Kaine said Friday that he has decided to sign legislation requiring all sixth-grade girls to get immunized against a virus that causes cervical cancer if their parents don’t object. Virginia, parents will be able to opt out of the requirement without citing a reason.”If they choose not to do it, they don’t have to do it,” said Del. Phillip A. Hamilton (R-Newport News), the sponsor of the legislation. “They just have to sign a form so the health department knows they opted out.” Merck has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. As in many states where cervical cancer legislation has been considered, there have been ties between drug makers and members of government. In 2006, one of Merck’s newly hired Virginia lobbyists was Sandra D. Bowen, who had spent years as Virginia’s secretary of administration. And Bill Bolling, the state’s lieutenant governor, became an outspoken participant in the “Ending Cervical Cancer in Our Lifetime” campaign, a program started in 2006 by the National Lieutenant Governors Association and financed largely by Merck and Glaxo.Since 1997 Merck has given $197,000 to Virginia politicians and campaign committees. The Virginia Public Access Project, a nonprofit campaign finance watchdog has found that “The pharmaceutical giant has given $10,000 to Del. Phil Hamilton, R-Newport News, and $4,100 to Sen. Janet Howell, D-Fairfax.” With such generous incentives, they have pushed vaccine mandates through the State Senate and House of Delegates claiming that it’s not about Merck, but about fighting cancer.
What could be driving this?
Money, cold hard cash, nice soft dollars, campaign donations, jobs for kids and friends, Merck carried a very big goodie bag.
Merck needed the sales of Garasil. In their world HPV means “Help Pay for Vioxx” Merck has lost millions in recalls and lawsuits over VIOXX which was found to increase risks of heart attacks and strokes.
Merck pushed hard for mandatory HPV-vaccinations. They spent time, treasure and talent working at the state, federal level, convincing elected officials and regulatory agencies that they, not parents, knew what was best for the daughters of our Nation. Below is the story of Merck’s run at Texas. At this time at least a score more are dealing with the issue of a mandatory HPV-Vaccination policy. As a Texan, I’d love to forget Rick (all hairdo / no active dendrites) Perry, is my Governor. Other days however, I’m grateful for his governmental ineptitude.
Perry got Merck incentives to push for the Gardasil mandates for fall 2008. Governor Perry, will never be confused with a Machiavellian strategist. His bugled attempt to distract and misdirect, culminated in a surprise executive order, mandating girls entering the sixth grade — meaning, generally, girls ages 11 and 12 — will have to receive Gardasil, Merck’s new vaccine. Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21.
The order was issued after hours, on the Friday afternoon, of Super Bowl weekend. Hey, this is Texas. Here, football is an aspect of the Holy trinity; the others being God, and country. The man truly thought no one would notice. He was genuinely stunned to find himself in the middle of a shock and awe, estrogen-fueled, firestorm. For one brief, bipartisan moment in time, all Texans were united, against Perry. Merck is bankrolling efforts to pass state laws across the country mandating Gardasil for girls as young as 11 or 12. It doubled its lobbying budget in Texas and has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.
Perry has ties to Merck and Women in Government. One of the drug company’s three lobbyists in Texas is Mike Toomey, Perry’s former chief of staff. His current chief of staff’s mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government. The governor also received $6,000 from Merck’s political action committee during his re-election campaign. None of which, of course had anything to do with his decision.
The uproar brought on by Perry’s ‘bought and paid for’ executive order resulted in a hearing brought on by House Public Health Committee. By May, 2007, the Texas state legislators sent Perry him a bill which bars state [health] officials from requiring the vaccine for school attendance. Asserting to only have interest in the health of Texas women, Perry stated that the subject should be moved out of the political arena and into the court of public opinion. One must remember he had no interest in the court of public opinion when he bypassed legislator AND public opinion by rushing into an executive order coincidentally after being handsomely paid by Merck to lobby their vaccine.
The public uproar over Merck’s predatory lobbying in Texas and other states as stirred up controversy and mistrust for the process. The rapid deployment of the HPV-vaccine, the marketing campaign that motivated, but failed to educate, left the public leery of the Merck party line. Texans were not inclined to support a school mandated HPV-vaccine that has only been on the market a few years.
What other state lawmakers pushing for the HPV-vaccine are getting incentives from Merck?
JAMA [Journal of American Medical Association] released publication on a study Feb 28,2007 on the prevalence of HPV in women between the ages of 14 and 59. Of the vaccine strains [ HPV-6, 11, 16 and 18] theprevalence was only estimated to be found in only 3.4% of the women. Amongst 18-25 year olds that would be deemed sexually active, only two percent were found to be infected with HPV-16 and HPV-18 associated with cervical cancer. May 2007 LA times reports on the New England Journal of Medicine released study which casts new doubts. Results show that 129 women would have to be vaccinated to prevent ONE case of cancerous lesions. Based on only three years of study, the vaccine reduces cervical cancer risks by only 17% over all.
This is a far cry from the previously stated[only] 50% by researchers in the past. Dr. Harper furthers states, “I don’t think this is the gun that is going to take cervical cancer off the map”. Assuming that the targeted strains are prevented from causing cervical cancer, doctors are concerned that other high risk strains will proliferate. Merck and Glaxo are already working on possibly adding the other strains to the vaccine.
Dr. Harper says that to mandate now is of NO BENEFIT to young girls but only to Merck’s profiting. The NEJM mentions that “some co-authors on the study are with Merck Research Laboratories which developed the vaccine and provided the funding.”
Jon Abramson, chairman of CDC’s advisory committee on immunization practices, is now claiming that he and panel members told Merck not to lobby state law makers to require the vaccine. This is called back paddling after the ACIP had already made the recommendation on the vaccine which is typically plays the lead role in the actions of the states when it comes to adding vaccines to the recommended schedule for school registration.
Resources:
Use of reactivealuminum in vaccine placebo study: Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. Table 6.
Merck and FDA did not disclose how much aluminum was used in the study http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine.
Human and animal studies show aluminum use result in neuron death: Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. PubMed 2001 May 15;55(2):211-7. 55, 211-217.
Aluminum crosses the blood brain barrier: Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue http://www.altcorp.com/DentalInformation/aluminumvaccines.htm
Aluminum crosses the blood brain barrier: Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide PubMed 1994 Apr-May;41(1-2):129-35
Aluminum causes chronic joint and muscle pain at injection site as well as fatigue: Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle Journal of Neurology Brain, Vol. 124, No. 9, 1821-1831, September 2001 http://brain.oxfordjournals.org/cgi/content/abstract/124/9/1821
80%-90% Post Vaccination Adverse Reactions Merck & Co. May 18, 2006. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B1.pdf
Food and Drug Administration. Product Approval Information – Licensing Action: GARDASIL Questions and Answers. http://www.fda.gov/cber/products/hpvmer060806qa.htm
2. American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society; 2005.
http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf
3. Saslow D, Runowicz CD et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin 2002; 52:342-362 http://caonline.amcancersoc.org/cgi/content/full/52/6/342
Prevalence of HPV Infections Among Females in the United States
2. American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society; 2005.
http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf
3. Saslow D, Runowicz CD et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin 2002; 52:342-362 http://caonline.amcancersoc.org/cgi/content/full/52/6/342
- Prevalence of HPV Infections Among Females in the United States
- FW Daily News.com, Cindy Bevington, March 13, 2007
- Deaths due to cervical cancer stats from National Cancer Institute http://seer.cancer.gov/statfacts/html/cervix.html
- Munoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348;518-27
- NIH Consensus Statement. Cervical cancer. NIH Consens Statement 1996; 14:1-38
