HPV Vaccines: Betrayal of the Public Trust?

By Norma Erickson, President

Last week, multiple news articles reported 44% of American parents refusing Gardasil or Cervarix for their children. Between 2008 and 2010, the percentage of parents concerned about the safety of these two vaccines nearly quadrupled. As of 2010, only 32% of eligible girls were vaccinated against HPV. What is wrong with this picture?

Excerpts from national news sources, March 18-22, 2013:

• USA Today The percentage of parents who say they won’t have their teen daughters vaccinated against the human papillomavirus increases, even though physicians increasingly recommend the vaccinations. Concerns about safety and side effects for the human papillomavirus (HPV) vaccine have increased among parents: 16% cited these fears as the main reason they did not have their daughters vaccinated in 2010, up from 5% in 2008…
• Medpage Today Parents increasingly say they are worried about the safety of the human papillomavirus (HPV) vaccine and don’t intend to vaccinate their teen daughters… But there is no similar pattern for two other vaccines aimed at adolescents…
• CNN Health Concerns of mothers and fathers about the safety of the HPV vaccine grew each year, from 4.5% in 2008 to 16.4% in 2010… The number of parents who said they would not vaccinate their children for HPV increased from 38.9% in 2008 to 43.9% in 2010. The main concern was safety.
• CBS News One of the main reasons parents said they didn’t want their children vaccinated against HPV was because of safety concerns.
• Bloomberg The number of girls who received either injection (Gardasil or Cervarix) rose to about one-third in 2010 from 16 percent in 2008…
• FiercePharma A growing share of U.S. parents say they won’t vaccinate their daughters… And that leaves Merck’s Gardasil and GSK’s Cervarix with a shrinking market.
• The New York Times …suggesting, the need for interventions beyond clinical recommendations like possibly ‘state and federally designed social marketing campaigns.’… Without brushing aside the need to address safety concerns, the increasing rates of HPV vaccine refusal suggest that widespread vaccination will require more than marketing campaigns. Medical professionals need to look for ways to tell a better story to parents and teens about HPV, vaccination and cancer. (emphasis added)

Taxpayer funded social marketing campaigns? Look for ways to ‘tell a better story’ to parents? Who are these people kidding? What happened to investigative journalism? What happened to fact-finding? What happened to fair and balanced journalism?

Has no one considered the possibility that the 43.9% of parents refusing this particular vaccine might have some valid concerns? When will people realize there is a huge difference between ‘increasingly concerned about the safety’ and ‘increasingly aware of the potential risks’? After all, this would not be the first time a prescription medication approved by the FDA as ‘safe and effective’ turned out to be nothing of the sort. Will HPV vaccines be next?

HPV vaccination programs worldwide are based on two assumptions. First, HPV vaccines will prevent cervical cancer and save lives. Second, HPV vaccines will pose no risk of serious side effects. Therefore, it would make sense to vaccinate as many pre-adolescent girls as possible to reduce the worldwide burden of cervical cancer. What happens if both of these assumptions are not based on factual evidence?^[1]

Medical Consumers Want to Know:

1. Since HPV vaccines have never been shown to prevent cervical cancer, why are they being promoted as cervical cancer vaccines?¹
2. Since the majority of HPV infections and a great proportion of abnormal lesions associated with cervical cancer development clear spontaneously without medical treatment, how can these factors be used as ‘end-points’ during clinical trials to reliably predict the number of cervical cancer cases that could be prevented by HPV vaccines?¹
3. How can the clinical trials make an accurate estimate of the risk associated with HPV-vaccines if they are methodologically biased to produce false negatives?¹
4. Why are HPV vaccines marketed so aggressively in developed countries, when 85.5% of annual cervical cancer cases and 87.9% of annual cervical cancer deaths occur in developing countries?^[2]
5. How can passive adverse event monitoring systems (voluntary reporting with no penalty for failure to report), such as those used by most vaccine surveillance systems world-wide, allow the medical regulatory agencies to make accurate estimates on the real frequency of HPV-vaccine related adverse reactions?
6. How can accurate estimates of the real frequency of HPV-vaccine related adverse reactions be made if appropriate follow-up and thorough investigations of suspected vaccine reactions are not conducted?

The FDA granted Merck’s HPV vaccine, Gardasil, fast track approval in June of 2006, despite the fact that this HPV vaccine failed to meet the FDA criteria for fast track approval.^[3] FDA approval of GSK’s HPV vaccine, Cervarix, followed shortly after in January 2007.

According to The New York Times, the CDC Advisory Committee on Immunization Practices recommended adding HPV vaccines to the immunization schedule in the U.S. despite the fact that 64% of the advisory committee members had potential conflicts of interest which were either never disclosed or left unresolved at the time they voted. 3% of the members actually voted on matters they had been barred from considering by ethics officers. News like this certainly does little to enhance the level of public trust.

Is it possible for the FDA to objectively monitor the safety and efficacy of HPV vaccines? One has to wonder since Congress tightened the rules on outside consulting after similarly undisclosed conflicts of interest were discovered within advisory committees at the FDA.

As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales.^[4]

Marketing Gardasil to the public under these circumstances is a typical case of unconstrained government self-dealing. The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers.  For example, Dr. Julie Gerberding, as the Director of the CDC, approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil.

How much revenue is generated for the NIH from international sales of HPV vaccines? In November 2010, Dr. Eric Suba submitted a Freedom of Information Request to the Office of Government Information Services to discover the amount. It seems the financial details of the partnership between the NIH, Merck and GlaxoSmithKline are exempt from disclosure. (Read the response he received here.) Apparently, transparency in government does not apply to the top 20 revenue producing patent(s) developed at taxpayer expense. Why is the public not allowed to share in celebrating the success of products they financed?

Three Strikes for Gardasil?

1. September 2011: Recombinant HPV DNA L1 gene DNA fragments, possibly attached to the aluminum adjuvant, were discovered in 100% of Gardasil samples tested. There was no subsequent investigation. The FDA simply declared the ‘expected’ presence of residual DNA is not a safety factor. No documentation was provided. The fact that HPV vaccines were approved by governments worldwide based on manufacturers’ assertions that the vaccines contained ‘no viral DNA’ was completely ignored.^{[5], [6]} The possibility of recombinant HPV DNA fragments being attached to aluminum adjuvant particles was also ignored.
2. August 2012: One of the antigens used in Gardasil was discovered in central nervous system samples from two girls who died after being vaccinated with Gardasil. No cause of death was identified upon autopsy in either case.^[7] HPV-16 L1 gene DNA fragments of vaccine origin apparently attached to aluminum adjuvant particles were also discovered in post mortem blood and spleen samples of a girl who died 6 months after Gardasil injections.^{[8], [9]}
3. February 2013: It was discovered that the naked HPV 16 L1 gene fragments bound to aluminum particles by ligand exchange in Gardasil have acquired a non-B conformation. This conformational change may have stabilized the HPV 16 gene fragments in Gardasil preventing their normal enzymatic degradation in vaccine recipients.^{[10], [11]} Non-B DNA conformations and their relationship to diseases has been studied since the 1960’s. Based on current scientific knowledge, the human genetic consequences of these non-B DNA structures are approximately 20 neurological diseases, approximately 50 genomic disorders and several psychiatric diseases.^{[12], [13]} The impact of injected foreign non-B DNA on human health is totally unknown. 

Why have none of these discoveries sparked a single investigation in any country? Why is no one concerned when genetically modified viral DNA fragments are found in vaccines that are reported to have no viral DNA? Why is no one worried about those viral DNA fragments being attached to aluminum (a known toxin) possibly creating a new chemical compound of unknown toxicity? Why are no red flags raised when those viral DNA fragments attached to aluminum acquire a non-B conformation – something known to be associated with multiple debilitating diseases? Anyone with an ounce of common sense should demand to know why those charged with approval, recommendation and safety monitoring of these vaccines appear to be utterly unconcerned about the future health implications of any one of these discoveries, much less all three of them.

What kind of ‘expert’ advice is being given to YOUR government health officials?

Israel’s Advisory Committee on Infectious Diseases and Inoculations held a teleconference on 30 January 2013, to discuss the proposed introduction of HPV vaccines into the country’s school inoculation program among other issues. The official transcript of that meeting, dated 11 February 2013, provides some interesting insights for medical consumers who question HPV vaccine safety.

Ron Dagan, MD, is Professor of Pediatrics and Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva, Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka University Medical Center, also in Beer-Sheva. An active researcher and international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His expert advice to Israel’s Advisory Committee regarding potential HPV vaccine implementation is as follows (translation provided-emphasis added):

We are dealing with injections, some of which given in 3 [separate] doses, which are delivered to teenage girls. Many side effects are to be expected. During the week following the vaccine delivery of the injections many serious events which are not related/linked to the vaccination are expected: fainting, deaths and convulsions/fits. This needs to be taken into account. Even if it is not rational, if these events happen in class they may damage the general perception/status of the vaccinations. This is happening all over the world all the time. We have already dealt with a similar issue in relation to the delivery of MMR with TD and Polio and we have accepted the nurse’s proposal to split these between grades 1 and 2. The nurses are suitable to make recommendations to the committee in relation to this issue. In relation to the side effects, we need to be prepared in advance and not simply react after the fact. I propose we consult with the English representatives as to how they’ve gone about this. We must prepare for the delivery of the new vaccine. The nurses need to know they are going about this in the way they are most comfortable with (/have the most control over/familiarity with).

If this is an example of the expert advice vaccination programs are based on, it’s no wonder medical consumers are questioning HPV vaccine safety, efficacy and need. Many side effects are to be expected? Fainting, deaths, convulsions and fits occurring during the week following vaccination – yet not related to the vaccine? Preparing in advance for side effects? Consulting with other countries to see how they handled the problem? Are countries around the world being offered similar expert advice?

So, what will it take to solve the HPV vaccine uptake problem?

Parental concerns about HPV vaccine safety are not going to go away in response to social media campaigns. Teaching medical professionals to ‘tell a better story’ is not going to make parents change their mind about Gardasil, Cervarix, or any future HPV vaccine. Platitudes and unsubstantiated reassurances are no longer sufficient.

The time has come for government health authorities to make HPV vaccine manufacturers prove their claims or pull their products from the market. Medical consumers want scientifically proven facts – Safe, Affordable, Necessary and Effective – nothing less is acceptable.

[2] WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in World. Summary Report 2010.

[3] Too fast or not too fast: the FDA’s approval of Merck’s HPV vaccine Gardasil. Tomljenovic/Shaw 2012

[4] Top 20 Commercially Successful Inventions, NIH

[5] SaneVax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil

[6] Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil® Lee 2012

[7] Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012

[8] Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil^® vaccination—A case report Lee 2012

[9] Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Tomljenovic/Shaw 2012

[10] Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt—A study by low temperature PCR, Lee 2013

[11] Gardasil: New Study Brings More Safety Questions to Light, Erickson 2013

[12] Non-B DNA conformations, mutagenesis, and disease, Wells 2007