Merck’s Gardasil science (lack thereof) taken to court

The article you are about to read is long. We hope you take the time to read it. Merck was brought before our justice system, and not just the mock of a court system called “vaccine court” when you have a vaccine injury. Our fight has been against the mandate of the HPV vaccine and to advocate informed consent. When reading the studies from Merck there has always been reason to not trust that the advertised benefit was worth the risk of injury; Now via these top lawyers in the case described- Merck has to answer for Gardasil.

Please forward this article to your representative and your senator (GardasilCourtCase.NOHPVmandateRI.com). Please call them and tell to support reversing the HPV mandate in RI, and to support H5165 for philosophical exemption. This case shows why informed consent and ability to act based on the information learned is imperative for all citizens.

kids world

=By Lyn Redwood, R.N, M.S.N., President, Children’s Health Defense

On Wednesday January 9th, I attended Science Day Presentations in the Jennifer Robi vs. Merck and Kaiser Permanente case in Los Angeles Superior Court. I want to report to our community on the outcome of this important event and provide some personal commentary.

It is difficult to describe the feelings of elation and frustration that I experienced during the full day of furious arguments that began at 9:30 am before Judge Maren Nelson. Due to the restrictions of the National Childhood Vaccine Injury Act, my son and thousands of children like him, have never been able to have their injuries acknowledged in a court of law.  This day gave families around the globe whose children’s health was permanently harmed by the HPV vaccine a glimmer of hope that their injuries and suffering would finally be acknowledged. The frustration I felt came from the obvious fact that the science relied on by our federal agencies to approve the HPV vaccine was criminally inadequate and that Jennifer’s injuries and those of the thousands of others like her could have been prevented.

Prior to Science Day, plaintiffs’ attorneys worried that because Judge Nelson threw out a $472 million 2017 jury verdict against Johnson & Johnson for causing ovarian cancer in women exposed to its asbestos-containing baby powders, the Court might not be very receptive to their arguments here. However, Judge Nelson gave scrupulous attention to the science presentations by both sides and clearly seemed to be approaching the Robi case with an open mind.

A red-letter day

After 20 years of advocating for vaccine safety, this was the first time that I’ve watched vaccine science issues adjudicated in a true court of law.  It was truly a red-letter day. Jennifer’s lawyers brilliantly laid bare Merck’s anemic case for Gardasil, dissecting the science in withering presentations challenging both the efficacy and safety of the Gardasil vaccine, and then chronicling the horrifying agency and corporate corruption that lead to its approval.

Jennifer Robi is a 24-year-old former athlete and scholar who has been confined to a wheelchair since receiving her third Gardasil vaccines at age sixteen. She suffers continual uncontrolled neuro/muscular contractions (jerking) and postural orthostatic tachycardia syndrome (POTS) and many other symptoms of systemic autoimmune dysregulation.

Jennifer’s attorney, Sol Ajalat, initially brought her case in Vaccine Injury Compensation Program and then, following a judgment in the program, elected to proceed in civil court. Since VICA (the Vaccine Injury Compensation Act) forbids recoveries for product defect or negligence, Ajalat brought Jennifer’s civil case under the theories that Merck committed fraud during its clinical trials and then failed to warn Jennifer (and, by implication, other injured girls) about the high risks and meager benefits of the vaccine.

In order to support Sol Ajalat and his sons Greg, Larry, and Steve, who compose the Los Angeles firm Ajalat & Ajalat, a blue ribbon A-Team of the nation’s leading plaintiffs’ law firms have joined Jennifer’s trial team. These include the firms most feared by Pharma: Weitz & Luxenberg (countless major pieces of litigation over 30 years), Morgan & Morgan (Vioxx, Phenphen, Breast Implants, Tobacco), Baum Hedlund, (Monsanto $289 million verdict 2018 and the $54 million 2000 verdict against Bayer in Haemophiliac/AIDS case) as well as Children’s Health Defense’s own Robert F. Kennedy, Jr. and Kim Mack Rosenberg (a co-author of The HPV on Trial). The plaintiff’s bar has steered clear of vaccine lawsuits since the 2008 Thimerosal fiasco which nearly bankrupted several big firms. Now, Merck, through its reckless overreaching with Gardasil—a public health flimflam currently emerging as the most dangerous vaccine in history—has brought the nation’s leading trial lawyers back to the brawl.

The three Merck attorneys who made presentations were Dino Sangiamo, Sally Bryan, and Christina Gaarder. Jo Lyn Valoff represented Kaiser.

Gardasil’s super-powered aluminum adjuvant

Plaintiffs began the day with a 2.5 hour presentation. Sol Ajalat first introduced Paul Pennock of Weitz & Luxenberg. Pennock ran through a riveting 50-minute slide show demonstrating how Gardasil’s super-powered Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) adjuvant over-stimulated the immune systems of vaccine recipients tipping them into autoimmune conditions in which their redlining immune defenses begin attacking their bodies’ own organs. This “autoimmune process” causes a cascade of illnesses that, in Jennifer Robi’s case, resulted in damage and deterioration in diverse organ systems throughout her body.

Victims like Jennifer are left exhausted as the body fights off disease on multiple fronts.  Pennock explained that vaccine makers add aluminum adjuvants (to weak antigens and a long list of other potentially toxic ingredients) to elicit an immune response, hoping to extend the short-term immunity otherwise provided by most vaccines. Among vaccinologists, it’s axiomatic that the duration of immunity correlates directly to the toxicity of the adjuvant; the more toxic the adjuvant, the longer the duration of immunity. Most vaccines provide immunity for only 5-10 years. Gardasil’s promoters were promising lifelong protection, and needed a super toxic adjuvant that would provide this unprecedented level of protection. After all, Merck was promising regulators, pediatricians and the public that inoculations given to 9-12-year-old girls would provide immunity against a relatively rare cancer that typically doesn’t kill until age 58!

Pennock explained that Merck has refused to disclose the contents of AAHS or to provide samples to independent and university scientists for testing.  AAHS, astonishingly, has never been safety tested by government regulators or by Merck. Studies on animals conducted by world renowned independent scientists like Dr. Chris Exley, Dr. Yehuda Shoenfeld, Dr. Chris Shaw and others have found that mice and sheep exposed to aluminum adjuvants, at concentrations comparable to those found in vaccines, develop strange behavioral patterns and illnesses resembling autoimmune diseases.

Using a poisonous placebo in the control group allowed Merck to mask the cascade of injuries suffered by girls in the Gardasil group during the clinical trials.

A parade of deceptive canards

Robert F. Kennedy, Jr. next gave the court an explosive 50-minute presentation of 112 disturbing slides describing the parade of deceptive canards that composed Merck’s clinical trials. Kennedy described a series of fraudulent gimmicks employed by Merck to deceive regulators during the clinical trials including the use of a “spiked” extremely toxic AAHS placebo rather than a true inert placebo that is standard for control groups in blue ribbon safety studies for other pharmaceutical products. Using a poisonous placebo in the control group allowed Merck to mask the cascade of injuries suffered by girls in the Gardasil group during the clinical trials.  Half the girls in the Gardasil group and half the girls in the spiked placebo group suffered serious injuries, including several deaths, in the first seven months of the clinical trials, yet Merck was able to claim that reactions in the study group “were similar to the reactions in the placebo group,” and that, therefore, the vaccine was safe. Merck reported most of these serious injuries as “new medical conditions” not adverse events, dismissing any connection to the vaccine by fiat. Information about this parade of grave injuries appears nowhere in the Gardasil package insert.

Merck committed its boldest fraud in its key clinical trial, Protocol 18.  Merck told FDA that Protocol 18 was the single study in which its researchers gave the control group a true inert placebo.  For this reason, FDA declared Protocol 18 “of special interest.”  However, in reality, Merck appears to have taken the precaution of removing half the aluminum from the vaccines administered to this study group. Plus, The Company laced the “placebo” with a witches’ brew of other toxic chemicals. This study, the only “controlled” study that included children in the target cohort of 9-12-year olds, may not have in fact tested the vaccine that Merck went on to inject into millions of young children around the world. Kennedy told the judge that this is not just scientific malpractice, it is outright fraud!

… Merck’s control groups did not reflect the target population for its drug.

Another tactic utilized by Merck was to purge the study group of anyone with the slightest vulnerabilities to the vaccine or its ingredients despite the fact that the vaccine would ultimately be marketed to girls with the very vulnerabilities excluded during the clinical trials.  This precaution allowed the company to mask effects that occur only in vulnerable subgroups.  Mr. Kennedy drew laughter from the large court room audience when he described how Merck had prescreened the study subjects to exclude people with allergies, immunological or nervous disorders, more than 4 lifetime sexual partners, genetic vulnerabilities to cancer or to any other medical condition, or with any hint of general infection, a history of alcohol or drug abuse, or a serious or chronic illnesses, and so forth. Finally, Merck told its researchers to exclude any individual with “any condition which in the opinion of the researchers might interfere with the study objective.” The remaining participants were an elite club of super healthy individuals. “You couldn’t get into the clinical trials unless you were a superhero,” Kennedy told Judge Nelson. “You had to be eligible for the Avengers.” The problem, of course, is that none of the people receiving the vaccine under CDC’s mandate are screened for these vulnerabilities. In other words, Merck’s control groups did not reflect the target population for its drug.

The mayhem caused by Gardasil

Even these flimflams could not conceal the mayhem caused by Gardasil.  Kennedy showed the court data from Merck’s own package insert showing that 2.3 % of the girls receiving the vaccine complained of symptoms of autoimmune disease within 7 months. Since cervical cancer kills only 1.5 Americans in every 100,000, he noted, “Merck’s own data show that the chances of getting an autoimmune disease from this vaccine are 1000 times the risk of dying from cervical cancer.”

Merck’s own data showed that administering the Gardasil vaccine to girls who had previous exposure to HPV actually raised their risk of developing precancerous lesions (or worse) by almost 45%.

Not only did a heartbreaking 50% of the subjects in both the study group and the spiked placebo group experience a serious adverse event within the seven months of the trial, death rates among girls in the study were double background rates. In fact, the rate for girls during the clinical trials (85/100,000) was 37 times the death rate from cervical cancer!  Birth defects among children conceived during the study period were 5x those of the control group and miscarriages were doubled over background rates. Reproductive problems among vaccinated girls were 10x background rates. Finally, Merck’s own data showed that administering the Gardasil vaccine to girls who had previous exposure to HPV actually raised their risk of developing precancerous lesions (or worse) by almost 45%. This revelation is particularly frightening since sexual behavior is only one of many vectors for acquiring HPV. Many children are exposed in the birth canal. Kennedy cited numerous studies showing many very young children are exposed to HPV, including one in which upwards of 34% of girls had exposure to HPV prior to age 10.

Kennedy closed his powerful presentation by chronicling the parade of corrupt conflicts that caused HHS officials to turn a blind eye to the rife fraud that characterized the clinical trials. Merck loaded the two FDA and CDC panels that approved Gardasil, with paid toadies. He showed that the pharmaceutical industry actually pays 45% of FDA’s annual budget and that NIH and its officials own part of the patents to the Gardasil vaccine and collect royalties on every vaccine sold.  NIH collects tens of millions of dollars annually from Gardasil sales.  Finally, 45% of CDC’s budget goes to promoting and purchasing vaccines.  Merck exerts control over the CDC with millions of dollars in contributions to the CDC foundation, which allows funding for pet projects.  This level of support gives Merck the power to also punish the CDC by withholding funding if displeased by the agency.

Jennifer’s illness due to Gardasil

Nicole Maldonado of Baum Hedlund next described the onset of Jennifer’s illness which worsened with each stage of the three vaccine series and how her symptoms were identical to the symptoms seen among hundreds of injured women during the clinical trials around the world, in places as diverse as Japan, Australia, Colombia, and Denmark (where special clinics have been set up to treat Gardasil’s victims), as well as among many girls here in the United States. These symptoms included menstrual irregularities, gastrointestinal dysfunction, musculoskeletal pain, neurological conditions and even death.

One courtroom observer, a concerned mother identifying herself as Rachel Harris said she felt sick to her stomach at the revelations. Jennifer Robi’s mom told me that she felt elated that Mr. Kennedy had mastered the facts so completely and that their family’s story was finally being told.

The rebuttal

The Defendants’ three-hour rebuttal was mainly toothless. Sangiamo doggedly described six studies, that he claimed were relied upon by the plaintiff, that had been retracted. However, only one of those studies was even mentioned on the plaintiff’s lengthy exhibit list (Plaintiff’s attorneys never referred to it in their briefs) and that study was republished elsewhere after the original journal retracted it under pressure from its pharmaceutical advertisers.

Sangiamo argued that the plaintiff had relied on case studies rather than large scale epidemiological studies of the kind largely funded by industry or the NIH which owns the Gardasil patent and profits on every injection sold.  He cited five of those NIH and industry-authored epidemiological studies that found no causal relationship between Gardasil and autoimmune diseases.  All are plagued by fatal defects such as only looking for a very limited number of potential injuries for a short period of time following exposure to the vaccine, despite the fact that autoimmune diseases can take months or years to manifest.  The authors of these studies had financial ties to Merck.

Finally, Merck’s Sally Bryan rose to the podium to explain to Judge Nelson that Merck’s AAHS adjuvant was safe because of the small quantities of this known neurotoxin in each vaccine.  She told the judge that “the dose makes the poison,” and that even water in large enough doses can be toxic. She pointed out that there are only 225 micrograms of aluminum in each vaccine. To illustrate how small this is, she asked Judge Nelson to imagine a dollar bill – which weighs one gram – cut into 1 million tiny pieces. She pointed out that only 225 of these pieces would be in any Gardasil vaccine, far too little to cause any adverse outcome. So in one breath, Merck was telling Judge Nelson that the amount of aluminum in Gardasil was substantial enough to permanently alter a person’s immune system to prevent cancer for the next half century and, at the same time, small enough to cause no harm.

The path forward

At the end of a long day, Judge Nelson ordered both sides to work out a discovery schedule and to reappear in court on February 7 to resolve any differences.

In Merck’s zealous promotion of the Gardasil vaccine, the company and its allies have shamed parents into vaccinating their children, through a series of misleading ad campaigns which play on parental instincts to protect their children from harm, especially from a disease as frightening as cancer. One commercial depicts young girl and boy actors recounting how they developed cancer from HPV and asking their parents if they knew this could have been prevented. “Did you know – Mom and Dad?”  Jennifer Robi has had the courage to tell a real-life story that the public rarely hears – about the risks of the Gardasil vaccine itself.

Watch RFK, Jr. describe his plan to take this issue to the courts


Original article from Children's Health Defense

 

 

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HPV Vaccines: Betrayal of the Public Trust?

HPV Vaccines: Betrayal of the Public Trust?

In 2013 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 Timessuggesting, 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 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.


The above article is from SaneVax.org and was written in 2013. This information is still valid and a reminder is in order for the current fight for our rights around the country and in RI about the HPV vaccine. #InformedConsent is essential and very important points are not being disclosed.

Since this article was published, last month there was a change in the dosing scheduled suggestions by the CDC. Where children under age 15 only need to receive two doses vs three doses. More specific details also apply.

Now on Nov 18th the CDC will hold a training to teach health care workers how to encourage the HPV vaccine and how to understand the new dosing recommendations by the CDC from Oct 2016.

Share this blog post with your legislator and schedule a time to sit down and speak with them.

The Acceptability of the HPV Vaccine Postpartum

The Acceptability of the HPV Vaccine Postpartum

This study is to get women who are not yet 26 but are pregnant to accept the Gardasil vaccination during postpartum. To have the pediatrician recommend the vaccine for the mother during the young child’s well visits.

Wonder if they will also inform that the package for Gardasil states that it is not suggested for breastfeeding mothers?

Follow our blog for more info too


Trial record 9 of 266 for:    HPV children

The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kimberly Kilfoyle, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02602626
First received: November 5, 2015
Last updated: June 7, 2016
Last verified: November 2015
  Purpose

The purpose of this study is to determine if women would find it acceptable to receive the HPV vaccine postpartum at the pediatrician’s office at the time of their child’s two-month well- child visit when offered during the third trimester of pregnancy.
Condition
Vaccination
Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:

  • Acceptability of HPV vaccination [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
    Estimation of the proportion of women indicating that they would be willing to receive the HPV vaccine postpartum at pediatric well-child visits if offered in the third trimester of pregnancy


Secondary Outcome Measures:

  • Proportion of women attending postpartum visits [ Time Frame: At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment. ] [ Designated as safety issue: No ]
    Estimation of the proportion of women who attend postpartum visits with their obstetric care providers


  • Estimate of baseline prevalence of prior HPV vaccination in study population [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Participants eligible for participation based on maternal age and gestational age will be screened for prior doses of HPV vaccine by self-report. Number of participants with self-report of prior HPV vaccination will be recorded and baseline prevalence from our population will be determined.


Other Outcome Measures:

  • Attitudes and beliefs regarding HPV immunization [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale


  • Health Literacy [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Health literacy will be screened using the “Newest Vital Sign” Measure


  • HPV and HPV vaccine Knowledge [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination


Enrollment: 600
Study Start Date: November 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Detailed Description:

There are a large number of young adult women who have not received any doses of HPV vaccine or are incompletely vaccinated. Recommendation for HPV vaccine could occur during pregnancy with the administration of the vaccine postpartum. Finding a way to make it easy for women to present for vaccination is imperative as this is currently a 3-vaccine series. The investigators are interested in understanding if women would find it acceptable if the investigators discussed and encouraged the vaccine while pregnant with receipt of the vaccine through their child’s pediatrician at well-child visits in the postpartum period. The investigators will survey women in the third trimester of pregnancy to determine if they would find this acceptable and follow-up with them after their child’s two month pediatric visit to reevaluate their opinion. No doses of the vaccine will be given.

The investigators are also interested in understanding other factors that could affect whether or not women would be interested in receiving the HPV vaccine postpartum. This includes rates of attendance at postpartum visits as well as behavioral, knowledge and demographic characteristics that may be associated with acceptability of receiving the vaccine.

  Eligibility

Ages Eligible for Study: 18 Years to 26 Years   (Adult)
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
Women will be recruited from the hospital based UNC Obstetric and Gynecology (UOG) Clinic including the resident clinic, faculty clinics and maternal fetal medicine clinics. The UOG Clinic cares for a diverse population of women from the immediate geographical area as well as referrals from 14 surrounding funded health centers.
Criteria

Inclusion Criteria:

  • Pregnant women at 28 weeks of gestational age or greater

Exclusion Criteria:

  • Primary language other than English or Spanish
  • Receipt of any prior doses of HPV vaccine.

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02602626

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kimberly Kilfoyle, MD University of North Carolina, Chapel Hill
Study Chair: Lisa Rahandale, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Kimberly Kilfoyle, MD, Clinical Instructor and Teaching Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02602626     History of Changes
Other Study ID Numbers: 14-2178  5T32HD040672-15
Study First Received: November 5, 2015
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:

Human Papillomavirus
HPV
Postpartum

ClinicalTrials.gov processed this record on June 30, 2016