Gardasil: THE ISSUE THAT JUST WON’T GO AWAY
I am Asking All Who Support The Search For The Truth In This Matter To Re-Post The Link To This Post On Your Face Book And Twitter Pages.
By Norma Erickson, President
2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.
In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:
§ 22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
§ 23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
§ 28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
§ 7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DN
§ A technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:
§ From the United Kingdom: HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
§ From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
§ From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
§ From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.
It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.
Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.
If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.
It is time for the manufacturers of HPV vaccines and government health agencies involved to provide scientifically sound proof that residual recombinant HPV DNA firmly attached to an aluminum adjuvant presents no current or future health risk to the children and young adults of the world.
When injecting a healthy population to attempt to control a disease that may occur 40 years down the road in a population that has limited or no access to good gynecological care, there is no excuse for taking on any additional risk involved with vaccination.
Until such time as documented scientific proof is provided, all potentially contaminated vaccines should be withdrawn from the market. Anything less deprives parents around the world of their right to informed consent when making healthcare decisions for their children.
SANE Vax Inc. believes it is the FDA’s responsibility to conduct an investigation based on the new scientific information to protect public safety. We believe it is irresponsible of the FDA to simply declare ‘…the presence of residual DNA is not a safety factor’ without ‘due diligence’ and supportive data.
“None so blind as those who will not see” or perhaps do not want to see. By turning its back on the young of America and not investigating thoroughly this new discovery, the FDA is defending the vaccine and not the child. What is it going to take to open the eyes of this organisation to see the truth? Who is going to shout loud enough to demand that they investigate Gardasil NOW and before another child dies.
To: Mr. Walter J. Gardner (email@example.com)
Re: Rebuttal to FDA response dated September 23, 2011
14 October 2011
Dear Mr. Gardner:
Thank you for taking time to respond to our September 2, 2011 letter addressed to Commissioner Hamburg, informing the FDA of our discovery of recombinant HPV DNA in Merck & Co.’s HPV 4 vaccine, Gardasil currently marketed worldwide.
Your response dated September 22, 2011 seems to indicate that the FDA is unaware of, or indifferent to the harms HPV vaccines have brought to medical consumers; primarily adolescent girls, as documented in the VAERS reports. Do you know how many parents have lost their perfectly healthy young daughters and how many parents still have to deal with the hardship of caring for their physically disabled or mentally impaired daughters as a result of Gardasil vaccinations?
There are at least seven reports published in the peer-reviewed medical journals containing documented links between HPV vaccination and a class of newly recognized, probably immune-mediated inflammatory neurodegenerative disorders, also described under the name of acute disseminated encephalomyelitis (ADEM).[1-7] These inflammatory pathologies in the central nervous system may constitute a highly likely cause for the commonly reported seizures, physical and mental impairments or even deaths following Gardasil vaccinations.
Your response appears to show the FDA has definitively dismissed the aforementioned peer-reviewed articles and the possible link of the confirmed cases of ADEM to HPV vaccinations, a link that has been universally suggested by the authors of the science-based articles.
Contrary to your assertion, recombinant HPV DNA does not have to be able to infect cells, or to self-reproduce to cause or to trigger a disease. When adsorbed to cationic particles, [8, 9] including aluminum adjuvant,  the DNA molecules can be inserted into human cells via mechanisms only recently recognized as nonviral gene delivery to their targets.
Chromosomal integration of foreign DNA may occur through poorly understood mechanisms [12, 13] with uncertain consequences. Recombinant DNA molecules have long been recognized as potential biohazards. Retention of residual recombinant DNA in protein-based vaccines has been a concern in the virology industry since the induction of cancer as a single-cell phenomenon. It is well documented that a single functional unit of foreign DNA integrated into the host cell genome might serve to induce cell transformation as a single event or part of a series of multifactorial events. 
SANE Vax Inc. believes it is the FDA’s responsibility to conduct an investigation based on the new scientific information to protect public safety. We believe it is irresponsible of the FDA to simply declare ‘…the presence of residual DNA is not a safety factor’ without ‘due diligence’ and supportive data.
Unlike other vaccines against contagious childhood infectious diseases, and even if proven effective as claimed, HPV vaccination is targeting 9-12 year old children to prevent 70% of cervical cancers which may develop at an average age of 54 at the death rate of <3 to 6.7 per 100,000 women in various population groups in the United States. Cervical cancer deaths are primarily the result of a lack of adequate gynecologic care.
For a vaccine to prevent a disease that may occur 40 years later, at a death rate of 3-6.7/100,000 - which may be further decreased by adequate and affordable gynecologic care, the risk to the vaccinated children should be zero to reap any benefits from said vaccination. As you are aware, all other childhood vaccines are used for public safety in the prevention of infectious diseases, not for a disease that may occur 40 years down the road in a finite demographic who have limited access to adequate gynecological care.
The members of SANE Vax and the thousands of parents whose daughters have suffered injuries or died after receiving Gardasil injections were shocked to learn for the first time that “Gardasil does contain recombinant HPV L1-specific DNA fragments,” as stated in your response on behalf of the FDA to our report of September 2, 2011.
Your statements, “The presence of these expected DNA fragments, which are inevitable in vaccine production; this DNA is not a contaminant; after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine; and Information concerning the presence of HPV DNA has never been in the U.S. labeling for Gardasil” seemed to play a semantics game when compared to the information data released to the consumers in public by the vaccine manufacturer with collaboration of the FDA and equivalent regulatory agencies in other countries.
Following are samples of some of the documents with relevant statements still available in the public domain:
1) A briefing document submitted to the FDA for the Gardasil™ Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting held on May 18, 2006 attached to a letter signed by Patrick Brill-Edwards, MD, Director Worldwide Regulatory Affairs Vaccines/Biologics of Merck Research Laboratories dated April 19, 2006, made public and posted on the FDA website, clearly stated that the vaccine (sic) “…contains no viral DNA”.
2) In another Gardasil® Supplemental Biologics Licensing Application for Use in Anal Cancer Prevention submitted as Briefing Document presented to the FDA VRBPAC on 17-Novemner-2010, it is again stated under 3.2 GARDASIL®- “The Quadrivalent HPV (Types 6, 11, 16, 18) Vaccine GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
3) In Submission Control No. 102682 to Health Canada by Merck Frosst Canada Ltd. GARDASIL™ - Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18), Recombinant Vaccine, Date 2007/03/16, it is stated “Gardasil™ contains HPV 6, 11, 16, and 18 L1 proteins in addition to the following excipients: amorphous aluminium hydroxyphosphate sulphate adjuvant, sodium chloride, L-histidine, polysorbate 80 (PS-80), sodium borate, and water for injection (WFI). The product contains no preservative or antibiotics. Gardasil™ is not a live virus vaccine. It contains no viral DNA and is not capable of causing infection. All excipients found in the drug product are acceptable for use in drugs according to the Food and Drug Regulations.”
4) In United Kingdom, Sanofi Pasteur MSD Limited Summary of Product Characteristics last updated on the eMC: 26/08/2011 states that Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. “The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.” http://www.medicines.org.uk/emc/document.aspx?documentid=19016
5) In an Australian Public Assessment Report for Gardasil submitted by Merck Sharp & Dohme (Australia) Pty Ltd February 2011, it states that GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce. http://www.tga.gov.au/pdf/auspar/auspar-gardasil.pdf
6) In New Zealand Ministry of Health Information for Health Professionals Data Sheet submitted by Merck Sharp & Dohme (NZ) Limited on 29 April 2009, it states that GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce. …Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of borax, and water for injection.
7) In the document issued April 2011 and titled as USPPI 9883616 Patient Information about GARDASIL®, the medical consumers are informed “The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.” There is no reference to DNA in the vaccine although yeast protein which is an adventitious substance is disclosed.
8) In HIGHLIGHTS OF PRESCRIBING INFORMATION 9883616, April 2011. GARDASIL is described as a “sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein/dose, and water for injection.” There is no reference to DNA in the vaccine although yeast protein which is an adventitious substance is disclosed and listed the amount present to be <7 mcg/dose.
The above documents clearly indicate that all documents #1- #6 issued prior to April 2011 contained the words ‘no viral DNA.’ However, the same reference has not been on the last two documents, #7 and #8 issued in April 2011. Comparing your statements with the history of records, it is highly disturbing to find out now that the FDA and vaccine manufacturer knew from the very beginning and withheld such an important material fact from consumers; namely that Gardasil has always been contaminated by residual recombinant HPV DNA.
Your statement ‘this DNA is not a contaminant’ is a simply another semantics game designed to evade inconvenient information. It grossly contradicts what the manufacturer has acknowledged and presented to the public.
For your information, the US patent #6,602,697 granted to Merck states:
“Specifically, it has been found that most contaminating biomolecules, including DNA, lipids and proteins are removed from the lysate.”
“Quantitation of L1 was made using a 2.5 mg load and yeast contaminants were quantitated at 20.0 mg loading.”
Therefore, again the record shows that the vaccine manufacturer has considered both residual DNA and yeast protein to be contaminants in the final product and as such must be removed. If not completely removed, it must be disclosed when it was detected. For example, the contaminant yeast protein was detected and listed as <7mcg/dose in April 2011 (See document above #8). Why was the contaminant HPV DNA not disclosed if known to exist?
To help medical consumers understand these very disturbing statements in your response, please provide answers to the following questions:
1) How large, in number of base pairs, are these recombinant HPV DNA fragments that are known to exist in the vaccine Gardasil?
2) Are these DNA fragments in the vaccine still spliced into plasmids? If not, please show data.
3) Can you provide a copy of the document in which the vaccine manufacturer reported that Gardasil does contain these DNA fragments, along with the date of the report made to the FDA?
4) What was the decision of the FDA issued on the above report? Why not make public the information about the existence of HPV DNA in the vaccine products? Who signed off the decision?
Your categorical denial that ‘there is no scientific evidence linking juvenile rheumatoid arthritis and vaccination with Gardasil’ grossly contradicts the safety data observed in the clinical trial which showed rheumatoid arthritis, including juvenile rheumatoid arthritis, occurred 3 times more frequently in the Gardasil®-vaccinated subjects than in the placebo control subject receiving aluminum placebo. Complexes of anti-DNA antibodies with microbial or self DNA may play a role in the activation of B cells by Toll-like receptors and surface IgM rheumatoid factor.[19, 20] The immunotoxic reactions may be further augmented by the aluminum adjuvant in the vaccine.
Your response and this letter of rebuttal will be posted on the SANE Vax website so medical consumers will be properly informed of the contradicting evidence on the risks and benefits of Gardasil vaccination. This will preserve their right to make an informed choice regarding the use of Gardasil for their families.
SANE Vax Inc. and the injured patients along with their families urge the FDA to immediately appoint a committee composed of unbiased scientists to review the safety impact of the newly discovered residual recombinant HPV DNA in Gardasil. All cases of unexplained deaths of young women following Gardasil immunizations must be reviewed and the brains obtained at autopsies re-examined by qualified neuropathologists to determine if an immune-based acute disseminated encephalomyelitis might be the cause of death.
Research must be conducted to determine if residual HPV DNA might have played a role in triggering the inflammatory lesions of the brain as a cause of death.
If you need more scientific evidence which will contradict your evaluation of the risks and benefits of Gardasil for adolescents age 9-26; especially those 9-12 years old, in the United States, please contact SANE Vax Inc. at your earliest convenience.
Thank you for your cooperation in performing your due diligence to reduce the unnecessary risks to future generations in this country.
Norma Erickson, President SANE Vax Inc.
154 Cecil Drive
Troy MT 59935
Signed on behalf of the Board of Directors, SANE Vax, Inc.
Leslie Carol Botha, Vice President of Public Relations
Janny Stokvis, Vice President of Research
Rosemary Mathis, Vice President, Victim Support
Freda Birrell, Secretary
Linda Thompson, Treasurer
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3. Mendoza Plasencia Z, González López M, Fernández Sanfiel ML,
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5. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924
6. DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010; 25:321-7.
7. Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I. A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship? (Abstract No. P297)- Poster Access :www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374
8. Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011; 2:222-4.
9. van der Aa MA, Huth US, Häfele SY, Schubert R, Oosting RS, Mastrobattista E, Hennink WE, Peschka-Süss R, Koning GA, Crommelin DJ. Cellular uptake of cationic polymer-DNA complexes via caveolae plays a pivotal role in gene transfection in COS-7 cells.Pharm Res. 2007 Aug;24(8):1590-8. Epub 2007 Mar 24.
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11. Matzuzawa Y, Emi N, Kanbe T. Calcium phosphate and aluminum hydroxide as non-virus gene carrier: the morphology of DNA-salt complex and the effects it has on DNA transfection. Kagaku Kogaku Ronbunshu. 2003; 29:680-684. In Japanese (English Abstract)
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15. Doerfler W, Schubbert R, Heller H, Kämmer C, Hilger-Eversheim K, Knoblauch M, Remus R. Integration of foreign DNA and its consequences in mammalian systems. Trends Biotechnol. 1997 Aug;15(8):297-301.
16. Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S, Zinder ND. Potential biohazards of recombinant DNA molecules. Proc Natl Acad Sci U S A. 1974; 71: 2593–4.
17. Hilleman MR. History, precedent, and progress in the development of mammalian cell culture systems for preparing vaccines: safety considerations revisited. J Med Virol 1990 May;31(1):5-12.
18.Testimony on Cervical Cancer by Nancy C. Lee, M.D. Before the House Committee on Commerce, Subcommittee on Health and Environment March 16, 1999 http://www.hhs.gov/asl/testify/t990316b.html
19.Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. Table 9. Merck 9883616
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22. Marichal T, Ohata K, Bedoret D, Mesnil C, Sabatel C, Kobiyama K, Lekeux P, Coban C, Akira S, Ishii KJ, Bureau F, Desmet CJ. DNA released from dying host cells mediates aluminum adjuvant activity. Nat Med. 2011;17:996-1002.
LISTEN TO THE BROADCAST BELOW!
On Tuesday, 11th October 2011, Clem was joined on air by Calverstown mother, Elaine Sammon. Her daughter got the HPV Vaccine last month, and Elaine says she became quite ill after it. She was critical of the HSE for the lack of information she felt was available. The HSE says it consulted with parents before publishing information, and the information is widely available. Elaine told Clem Ryan her story.
The HPV vaccine, Gardasil, has been much in the news lately with several of the Republican Presidential candidates stating an opinion regarding it. Consequently, we at The Vaccine Xchange have also been posting on the subject fairly frequently.
More people definitely deserve to know about the risks attached to the vaccine: it has been linked to Guillain Barre Syndrome, has been known to aggravate pre-existing HPV symptoms, and has not been tested against most adolescent vaccines. Since it protects against only two of the fifteen strains of HPV that can cause cervical cancer, it is not terribly effective, either; and we cannot tell the success rate of the vaccine for even these two strains since the vaccine has only been given to young girls, whereas it is middle-aged women who most commonly develop cervical cancer.
With these serious flaws in the vaccine itself, how has the HPV vaccine become so commonly recommended?An editorial in the Journal of the American Medical Association examines just that issue, and uncovers some very disturbing facts.
The editorial points to a report that demonstrated that some of the foremost medical organizations – the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, and American College Health Association – helped market the vaccine to public and policy-makers alike using ready-made presentations, emails, and letters provided by the vaccine manufacturer. This marketing program began even before the vaccine trials were published, which means that the associations still did not know how effective and safe the vaccine was when they were marketing it. The enthusiastic marketing, however, even without this evidence, may have mislead their members to accept their clearly biased data as balanced and factual.
Another article mentioned in the editorial describes the adverse effects reported through the US Vaccine Adverse Events Reporting System (VAERS) by vaccine recipients. We have mentioned these reports elsewhere; here, we need to remember that even those infected with HPV will likely not develop cancer if they undergo regular screening. As such, obviously, the vaccine itself is only useful if there is only a small risk of harmful effects. Yet the number of adverse effects associated with the vaccine on VAERS make it clear that it is possible that the risk is far higher than we may assume.
How could the medical associations continue to ignore such glaring problems? And with pharmaceutical companies lobbying our physicians so aggressively, how can we, as patients, ever know whether doctors are looking out for our health, or merely acting as marketing reps for the vaccine manufacturers? It is hard to reach an answer on these issues, but it is obvious that in today’s world, it is up to parents to do the necessary research before making an informed choice about whether or not to vaccinate.
JAMA. 2009;302(7):795-796. doi: 10.1001/jama.2009.1215
The Risks and Benefits of HPV Vaccination
When do physicians know enough about the beneficial effects of a new medical intervention to start recommending or using it? When is the available information about harmful adverse effects sufficient to conclude that the risks outweigh the potential benefits? If in doubt, should physicians err on the side of caution or on the side of hope? These questions are at the core of all medical decision making. It is a complicated process because medical knowledge is typically incomplete and ambiguous. It is especially complex to make decisions about whether to use drugs that may prevent disease in the future, particularly when these drugs are given to otherwise healthy individuals. Vaccines are examples of such drugs, and the human papillomavirus (HPV) vaccine is a case in point.
zur Hausen, winner of the Nobel Prize in Physiology or Medicine in 2008, discovered that oncogenic HPV causes cervical cancer. His discovery led to characterization of the natural history of HPV infection, an understanding of mechanisms of HPV-induced carcinogenesis, and eventually to the development of prophylactic vaccines against HPV infection.
The theory behind the vaccine is sound: If HPV infection can be prevented, cancer will not occur. But in practice the issue is more complex. First, there are more than 100 different types of HPV and at least 15 of them are oncogenic. The current vaccines target only 2 oncogenic strains: HPV-16 and HPV-18. Second, the relationship between infection at a young age and development of cancer 20 to 40 years later is not known. HPV is the most prevalent sexually transmitted infection, with an estimated 79% infection rate over a lifetime The virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system. In a few women, infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now. The true effect of the vaccine can be determined only through clinical trials and long-term follow-up.
The first HPV vaccine was licensed for use in the United States in June 2006, and the Advisory Committee on Immunization Practices recommended routine vaccination of girls aged 11 to 12 years later that same month. However, the first phase 3 trials of the HPV vaccine with clinically relevant end points—cervical intraepithelial neoplasias grades 2 and 3 (CIN 2/3)—were not reported until May 2007. Previously only reduction in the prevalence of persistent infection and CIN from the 2 virus strains included in the vaccine had been reported. The results were promising, but serious questions regarding the overall effectiveness of the vaccine for protection against cervical cancer remained to be answered, and more long-term studies were called for. However, no longer-term results from such studies have been published since then.
So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls a vaccine that partly prevents infection caused by a sexually transmitted disease (HPV infection), an infection that in a few cases will cause cancer 20 to 40 years from now? Two articles in this issue of present important data that may influence, and probably already have influenced, such decisions about HPV vaccination.
The report by Rothman and Rothman demonstrates how the vaccine manufacturer funded educational programs sponsored by professional medical associations in the United States. The article illustrates how the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, and American College Health Association helped market the vaccine and influenced decisions about vaccine policy with the help of ready-made presentations, slide sets, e-mails, and letters. It is of course reasonable for professional medical associations to promote medical interventions they believe in. But did these associations provide members with unbiased educational material and balanced recommendations?
Did they ensure that marketing strategies did not compromise clinical recommendations? These educational programs strongly promoting HPV vaccination began in 2006, more than a year before the trials with clinically important end points were published. How could anyone be so certain about the effect of the vaccine? This matters because the voices of experts such as the professional medical associations are especially important with a complex issue such as this.
In another article, Slade and colleagues from the US Centers for Disease Control and Prevention and the US Food and Drug Administration describe the adverse events that occurred 2.5 years following the receipt of quadrivalent HPV vaccine that were reported through the US Vaccine Adverse Events Reporting System (VAERS). Even though most of the reported adverse events were not serious, there were some reports of hypersensitivity reactions including anaphylaxis, Guillain-Barré syndrome, transverse myelitis, pancreatitis, and venous thromboembolic events. VAERS is a passive, voluntary reporting system, and the authors call attention to its limitations. They point out that only systematic, prospective, controlled studies will be able to distinguish the true harmful effects of the HPV vaccine. These limitations work both ways: it is also difficult to conclude that a serious event is not caused by the vaccine.
Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.
When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.
1. , Oslo, Norway.