HPV vaccine - Page 4

Are Safer Vaccines Possible?

1257 views

Perhaps, but only if we can admit that some vaccines cause injury and rework the entire vaccine development and monitoring system.

Vaccine Safety

Vaccine safety is a controversial topic, almost as controversial as politics or religion. In polite company, it is best not to bring up the subject, lest an all-out shouting match ensue.  On the one side, we have the pro-vaccine camp, who believes wholeheartedly that every vaccine is necessary and safe – ‘why else would they be on the market?’ is a common refrain. On the other, the anti-vaccine crowd, who for various reasons, are against vaccines. Some among the anti-vaxers are fundamentally against all vaccines as a matter of religious or libertarian principle. In their eyes, vaccination represents the worst of big government subjugation. It is an attack on their very freedom. Others in the anti-vax crowd come to their views experientially, through injury or tragedy.  Somewhere in the middle, the rest of us, parents, scientists, doctors and health advocates who are neither for nor against vaccines in principle, but who just want our kids to be safe and healthy.

Beyond For or Against

Much like the polarization of politics, the polarization of the vaccine safety and efficacy, all but nullifies reasoned concerns. One is either for or against vaccines. There is no grey area. This is fantastic for vaccine manufacturers because every concern, every injury can be written off by simply de-legitimizing the claimant – placing them in the nutty anti-vax camp, while correspondingly and overwhelming flooding the media with pro-vaccine marketing. Money does indeed buy power and power protects profits. With virtually all vaccines licensed manufactured by just five companies and revenues exceeding $25 billion annually and growing, the money and power are highly concentrated.

Stepping back though, away from the money and marketing, why anyone with a brain would believe that any vaccine or medication was universally safe and effective defies logic, not to mention the inherent variability of human physiology. To be entirely and ardently pro-vaccine as many are, one has to choose to ignore that basic fact – that for some people, some vaccines and medications either will not work or worse, will cause great injury. To ignore that fact, especially when there are no direct financial incentives to do so, one has to invalidate the tragedies that are in front of them; to convince oneself that the injured person before them is either lying to gain attention or simply is not credible and therefore not to be taken seriously. Either way, the net result of de-legitimizing injury, is to shutter the possibility of additional research, research that might find a connection. It’s quite a deft bit of cognitive dissonance, more so as the evidence of injury mounts.

De-legitimizing a claim of vaccine injury is easy; attack the person, not the claim, label the mom (because it is almost always moms making these claims) as irrational (hysterical), ignorant, and best of all, as anti-science; as if science is infallible and all-knowing rather than dynamic and changing. Ironically, bolstering the certitude of science, especially that which comes from organizations whose fiduciary or political obligations demand results remain in their favor, does more to reduce the credibility of the scientific endeavor and the public trust than simply admitting that sometimes the science is wrong or not nearly as clear as we once had believed. Polarization is more than just annoying and inconvenient. It is dangerous.

Skewed Development and Evaluation Process

As with the drug industry, especially after the recent Supreme Court decisions, the entire infrastructure of the vaccine industry is skewed in favor of finding vaccines safe and effective. There is very little space or motivation to find a vaccine dangerous. According to a recent report on Conflicts of Interest in  Vaccine Safety Research:

Fixing the Vaccine System – The Long Game

There is no easy or quick fix. The systems and barriers to vaccine, and indeed, drug safety are deeply entrenched in organizational and legal frameworks. The pendulum has swung so far away from consumer safety in favor of corporate protections that efforts to fix these problems must be viewed in terms of a long game; one that recognizes institutional and policy change has to take place over the next 10-20 years. The first step, however, is to recognize there is a problem and that vaccine injuries are likely within a system where there is little transparency and even less accountability for injuries.

The second and more difficult phase includes the major policy and infrastructure changes.
Those are a mess. Many are discussed in the piece Conflicts of Interest in  Vaccine Safety Research.  Many more need to be added. I will be writing a piece on this topic over the coming weeks. If you would like to contribute your thoughts on removing conflicts of interest from the vaccine safety and indeed, the entire drug development and review process, send me a note. In the mean time, we’re doing our part to understand Gardasil and Cervarix, vaccine safety and injury.

Help Find the Answers – Participate in Research

Hormones MatterTM is conducting research on the side-effects and adverse events associated with the HPV vaccines Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

Share

Gardasil Cervarix Online Study Continues – Participate Now

1438 views

Controversy surrounds the HPV vaccines, Gardasil and Cervarix. Since their release, the vaccine industry, the media and medical societies have touted the safety and success of the vaccines in preventing or reducing HPV viral infections and thus, in preventing cervical cancer. Patient groups, mom’s of vaccine injured girls and anti-vaccine groups on the other hand, argue loudly that the rate and severity of serious adverse events are seriously under-reported by industry and the proof that these vaccines prevent or reduce cervical cancer is lacking. Even one of the lead developers of the vaccine, Diane Harper has come out against it.

Somewhere in the middle is the Vaccine Adverse Event Registry (VAERS), where only 1-10% of a very limited range adverse events are reported. Even with the limited reporting to VAERS, the severity and frequency of adverse events is growing and should not be ignored. Data collected from VAERS indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage. This is compared to a risk of cervical cancer of 7.9 per 100,000 and death from cervical cancer at 2.4 per 100,0000 cases in the US.

Considering the severity of the reported adverse reactions and the noted adverse events reporting rate of less than 10% of all cases, having more credible and complete data about true severity and prevalence of said reactions as well as more detailed data about who is at risk for those adverse events is critical.

As a parent, a researcher and the founder of Hormones MatterTM, I decided to do something about the lack of data in this and other areas of women’s health. As part of the Real Women, Real Data series,  The Gardasil Cervarix HPV Vaccine Survey was launched In May of 2013.  It is a comprehensive, online study of Gardasil and Cervarix side-effects and adverse events. The study will run until a study sample of 1000 is reached. The goal is to provide a more accurate and unbiased look at the rate, range and severity of side-effects and adverse events associated with the HPV vaccines, Gardasil and Cervarix.

Take a survey. Share a survey. Suggest a survey.

We need your help to gather these data.  Please take this survey, if have had either vaccine – whether you experienced any side-effects or not. Understanding who is at risk and who is not, is very important. Share the survey link with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. Please post it on your Facebook pages and share on Twitter, Linkedin, Reddit and other social media. Write about and re-post this link on your blogs. Anything you can do to spread the word is appreciated. We will need at least a thousand women to find the connections.

It is up to us to protect our daughters. Understanding this vaccine is one way to do that.

Purpose the Gardasil – Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for and nature of adverse events associated with each of the HPV vaccines, Gardasil and Cervarix.

Who Should Take the Gardasil Cervarix HPV Vaccine Survey?

Girls or women who have been given either vaccine or the parents or other family members of young girls given the vaccine.

We are not currently collecting data on the adverse reactions for men and boys, but intend to launch a separate survey to tackle that population.

How Long Does the Gardasil Cervarix HPV Vaccine Survey Take?

This is a long survey. We felt it was important to assess the full depth, breadth, onset and severity of adverse reactions in order to give parents and women the data they need to make informed medical decisions. This necessitated a longer than desired survey. We estimate it will take approximately 20-30 minutes to complete the survey.  We hope, given what is at risk, survey respondents will take the time to complete the entire survey.

Is the Survey Anonymous and Secure?

Yes. We do not collect personal identifying information and the survey is hosted with SSL encryption using a verisign certificate Version 3, 128 bit encryption.

How Will the Data be Used?

To inform future research and women’s health decision-making.

Who is Conducting this Research?

Researchers from LucineTM, Hormones MatterTM. For more information on Lucine, click here. For more information about Hormones MatterTM , click here.

What Can I Do To Help?

Our organization is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. Get involved and help us prove that hormones matter and that women’s health data matter. Become an advocate, spread the word about our site, our research and our mission. Join our team. Write for us, partner with us, help us grow. For more information contact us at: info@hormonesmatter.com.

To take the Gardasil Cervarix HPV Vaccine Survey, click here.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

Thank you in advance for your help.

Share

Latest Gardasil HPV Research Fact or Fiction

1046 views

Recently, all the major media reported that the HPV vaccine was working. By their reports, the research showed a 56% reduction in HPV rates for vaccinated girls aged 14-19.

Even a decidedly feminist blog jumped on the bandwagon:

Perhaps one of the only reports to question the validity of these findings comes from an oncology blog for nurses. Assessing the Overall Impact of the HPV Vaccine – well worth the read. Leslie Botha from Holy Hormones Journal adds additional points of contention worthy of consideration. What the rest of the media failed to recognize and repeatedly fails to recognize either by want or by ignorance is that press releases are not often factually correct; something we write about regularly for Gardasil (here, here) and other medications or research (here and here). If a news or media organization is to report on medical and scientific research, they must be prepared to read and critically evaluate the actual research. Otherwise, they ought to label these reports what they are – advertisements.  Here is my take on the latest HPV research.

Behind the PR: Understanding the Research

Every couple years the Centers for Disease Control (CDC) and the National Center for Health Statistics (NCHS) sponsor what are called NHANES studies (National Health and Nutrition Examination Studies). These are health questionnaires sent out to a few thousand individuals deemed to be a representative portion of the population. Depending on the topic of study there are also laboratory based tests and/or in person followups at mobile examination centers (MEC). The study bandied about by the press, was published in the Journal of Infectious Disease (JID) by Markowitz et al., 2013. It compared NHANES data collected from 2003-2006, the pre-vaccine era and from 2007-2010, the post-vaccine era. An earlier study, also published in JID, but authored by Dunn et al. 2011, looked at the NHANES data from 2003-2006 and served as the foundation for Markowitz’s pre-vaccine/post-vaccine HPV analysis.

Background: HPV Prevalence and the Reported Reduction

Even a cursory reading of the Markowitz report – the report on which the PR suggesting HPV success is based –  immediately reveals problems. A deeper dive that includes the earlier JID study, the foundational pre-vaccine data to which the post-vaccine data is compared, demonstrates a statistical sloppiness that is difficult to attribute to ignorance. Numbers are missing, incorrect and misleading.

At the most basic level the data presented about the HPV vaccine’s effectiveness in the reported and marketed extensively by every major and media company are overblown and just a little bit hinky.  While it is true that the researchers report a 56% reduction in HPV rates in girls ages 14-19, that represents only a modest decline in the combined HPV rates (11.5% to 5.1%) tested. What the PR did not mention:

  • Other age groups saw an increase in HPV rates between the pre-vaccine era and post-vaccine era, suggesting that not vaccinating may be better
  • To arrive at this reported 56% reduction for the 14-19 year olds, the researchers had to combine the prevalence rates for each HPV strain tested (not all girls tested positive for all strains), then weight the results and transform – normalize the data to account missing data points and reign in the confidence intervals. The pre-vaccine prevalence rate of 11.5% was arrived at by summing the prevalence rate for each vaccine strain (HPV 6 was 5.4%, HPV 11 was 1%, HPV 16 was 6% and HPV 18 was 1.8%), but we would only know this if we pulled the 2011 study from whence the 11.5% figure came. Markowitz et al. did not annotate this figure. Not all girls had all strains and only HPV 16 and 18 are considered oncogenetic – potentially cancer causing.  Without noting how the 11.5% figure was arrived at and which strains changed from pre- to post-vaccine era, there is no way to determine whether the reduction from 11.5% to 5.1% came from the oncogenic or non-oncogenic strains. Nor is there any way to tell if the prevalence of certain strains increased over time instead of decreased. What if the observed reduction from 11.5% to 5.2% was largely based on HPV 6 – which initiates no more than genital warts?
  • From the total sample of 1363 pre-vaccine era girls and 740 post-vaccine era girls considered, girls from both time periods who were not sexually active and had no record of HPV or vaccine data were included in the original analysis reported in the PR. There was no stratification by these variables in the 56% improvement rate reported.
  • In secondary analysis, when HPV status was evaluated, only a very small sample size of sexually active girls in this age group (111 in the pre-vaccine data and 239 from the post-vaccine data, 8 girls from the post-vaccine sample had no HPV records) were included. These stratified data show that the rate of HPV was lower in non-vaccinated girls at 38.6% compared to 50% in vaccinated girls. So much for the most basic measure of efficacy.
  • The ages of sexually active versus non-sexually active by vaccine status were not given and thus, there is no way to determine whether vaccinating younger, non-sexually active girls has any protective capacity years later when the actual risk for HPV presents.
  • The error rates for some of the reported statistics, hailed as supporting the vaccines were over 30% (how much over, we do not know). Regardless, a >30% error rate is not a acceptable.

Read and Evaluate the Primary Research

Unless and until we get accurate and unbiased data from a large sample, that can be evaluated and verified independently, there is no way to tell if the risks of adverse events associated with this vaccine are reasonable and outweighed by the benefits of preventing cancer. Currently, data collected from the Vaccine Adverse events registry (VAERS) indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. (Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage). This is compared to a risk of cervical cancer of 7.9 per 100,000 and death from cervical cancer at 2.4 per 100,0000 cases in the US. Considering VAERS contains only 1-10% of the total adverse events, the probability increased adverse events is high, so determining the benefits and the efficacy of this vaccine are important.

Who to Trust?

The more the vaccine industry, the CDC, the FDA and other agencies continue to promote truly spurious studies as relevant and proof-positive that a particular vaccine or medication is safe and effective, credibility is lost.  Without an effective counterbalance to the specious claims made by industry, consumers are left fending for themselves. What is perhaps the most dangerous result of this constant barrage of medical marketing and PR is that individuals who may truly benefit from certain vaccines or medications will avoid taking them because of the loss of trust. For the time being, you must pull the research, read and evaluate the studies yourself.

Help Find the Answers – Participate in Research

Hormones MatterTM is conducting research on the side-effects and adverse events associated with the HPV vaccines Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

Share

Rolling the Dice with the HPV Vaccine

1443 views

If you are the parent of a minor child, you most likely have heard about one or both of the HPV (human papillomavirus) vaccines currently on the market. A trip to the pediatrician’s office with a teen or pre-teen is typically where the first discussion takes place. The doctor will dutifully recite information. HPV is the most common sexually transmitted virus in the United States. As a parent, that gets your attention. They go on to further state that the vaccine will protect your child from the strains of the virus that most commonly cause cervical cancer in females and genital warts in males. These are both very uncomfortable subjects for most of us. However, as parents, we want to protect our children at all costs from anything and everything possible.

As with any vaccine, the parent is provided a pamphlet or sheet containing the standard information: what is HPV, why get vaccinated, who should get vaccinated, and the obligatory safety information. After reading the information and listening to the doctor’s recommendation explaining that the vaccine is very safe (and it seems to be for most patients), many parents make the decision to have their child protected. I was one of them. I rolled the dice and sadly, my daughter lost.

The information pamphlet states that the vaccine has been used in the United States for about six years and has been very safe. You are warned about pain and swelling of the injection site, fever, headache, and the most troublesome side effect, fainting. The patient is required to remain in the doctor’s office for a period of time after the injection as a safety precaution.

What the information pamphlet does not address is that over 29,300 injuries and 136 deaths have been reported following HPV vaccines. Vaccine injury reporting is voluntary in our country and the Center for Disease Control acknowledges that adverse events, as they are called, may be 10 to 100 times greater than those actually reported. Do the math.  The reported numbers seem very significant to me, but I am the mother of one of the injured. I trust we can all agree that the actual numbers could be staggering.

The list of new medical conditions being reported following the HPV vaccine is also staggering, I counted 144 conditions. My daughter has 31 of them. She suffers mainly from neurological, autoimmune, and adrenal issues. The worst offender is a migraine-like headache that has been present every day, all day and night for more than a year. The neurologist refers to it as migraine-like because all the symptoms are there yet it does not respond to any medication. Her immune system has also been compromised. She suffers from leaky gut syndrome and now has sensitivity to 20 common foods. Dealing with this for more than a year now has taken a toll on her 16-year-old body. Chronic pain has lead to depression and adrenal fatigue. All of this in a girl who had what was described as an “unremarkable’ medical history prior to vaccination.

While my daughter’s symptoms are grave, she really is one of the lucky ones.  Many of the injured suffer from daily seizures or even multiple seizures per day.  My daughter does not. For that, I am thankful every day. Having a child in crisis is hard. Having a child with a medical crisis that medical doctors do not know how to reverse is even more difficult. My decision to protect her, in fact, caused her great harm.

Choosing to give your child a vaccination is a personal decision, but it is one that should not be taken lightly. Do your own research, do not simply rely on the information pamphlet, it is, after all, written by the vaccine manufacturer. I learned this lesson the hard way.  When you decide if you will roll the dice, please, for the sake of your child, remember this:  Education conquers fear and knowledge is power.

Gardasil Cervarix HPV Vaccine Research

Hormones MatterTM is conducting a large scale assessment of symptoms and adverse reactions associated with the HPV vaccines, Gardasil and Cervarix. If you, your daughter, other family member or friend have had either of these vaccines, we encourage you to take this important survey. The data collected with help delineate the range, severity, frequency and onset of health symptoms associated with Gardasil and/or Cervarix. For more information or to take the survey: The Gardasil Cervarix HPV Vaccine Survey.

 

 

 

Share

Gardasil Autopsies Reveal Cerebral Vasculitis

2650 views

Controversy about Gardasil and Cervarix related injuries surrounds the HPV vaccine. Almost to a tee, major medical centers, presumed thought leaders, post market surveillance, regulatory agencies and the press, promote the safety of these vaccines. It is incomprehensible to these organizations that such a perfect vaccine could cause serious injury or death. Any new report suggesting otherwise is quickly and summarily rejected, the families of the young women injured or killed are lambasted.  Rarely, does anyone standup and support the injured, lest they too be considered among the fringe. All the while, girls and women and their families continue to be injured or even worse lose their lives, by what pro-industry PR suggests are unexplained reasons.

Well, explain them damn it. If it is not the vaccine, then what? Neither the post-vaccine reactions nor the deaths are random and though the culprits may be complicated, basic human decency, not to mention medical ethics demand that we make an effort to understand the causes of the adverse reactions so that we might prevent them.

Looking for Clues

A group of researchers from University of British Columbia are attempting to do just that –  to understand the constellation of adverse reactions reported post vaccine. In one of their latest reports, published last fall in the open access journal Pharmaceutical Regulatory Affairs, they uncovered evidence of a deadly and difficult to diagnose condition called cerebral vasculitis.The syndrome fits clinically based on the presentation of symptoms reported. The study is not without problems and certainly not without criticism from industry. Here is a review and my thoughts on the research and the reactions to the study from industry and regulators.

What is Vasculitis?

Vasculitis is an autoimmune mediated attack within the walls of the blood vessels, that weaken and sometimes necrotize or kill the vessel. The central feature of vasculitis is the inflammatory destruction of the blood vessel. Vasculitides, as they are called, can develop anywhere in the body, in large or small vessels. Where the vasculitides develop and the size and type of vessels involved determines the types of symptoms that present and how the functioning of the injured physiological system will be affected.  As a result, the symptoms often appear heterogeneous and non-specific, making vasculitis very difficult to diagnose – unless one was looking for it. This report suggests that we ought to begin looking for it.

Peripheral and Cerebral Vasculitis

When vasculitis occurs in the body – peripheral or systemic vasculitis, symptoms include but are not limited to:

When vasculitis develops in the central nervous system – the brain and the spinal cord, symptoms include but are note limited to:

  • nerve problems (including numbness, muscle weakness, and pain)
  • severe headaches that last a very long time
  • strokes or transient ischemic attacks (“mini-strokes”)
  • forgetfulness or confusion
  • delirium and/or depressed consciousness
  • problems with eyesight (likely problems with hearing, but no cases cited)
  • speech problems
  • emotional regulation problems
  • seizures or convulsions
  • encephalopathy (swelling of the brain)
  • sensation abnormalities

Cerebral vasculitis, also called autoimmune encephalitis, represents one of the rarest forms of vasculitis because it requires the toxin or mediator to cross the blood brain barrier. Current estimates suggest an annual incidence of only 1-2 cases of cerebral vasculitis per million adults. Cerebral vasculitis is also the most deadly, as the immune system mediated attack of the small to medium blood vessels in the brain often leads hemorrhagic or ischemic stroke and can lead to death.

Gardasil Autopsy Reports

The current study, Death after Quadravalent Human Papillomavirus (HPV) Vaccination: Causal or Coincindental? examined the brain tissue of two young women who died suddenly after receiving the HPV vaccine, Gardasil. One of the young women was 19, healthy, medication free and had no previous medical history. She died in her sleep after being given the third dose of the vaccine, which elicited an apparent exacerbation of symptoms that had developed soon after the first dose.The symptoms that emerged after her first dose included: warts on her hands, fatigue, muscle weakness, tachycardia, chest pain, tingling in her extremities, irritability, confusion and memory lapses or amnesia.

The other young woman was 14 years old, had a history of migraines and was using oral contraceptives. Within two weeks of her first dose, she developed a constellation of symptoms that included exacerbation of migraines, speech problems, dizziness, weakness, inability to walk, excessive vomiting, depressed consciousness, confusion, amnesia. Two weeks after the second dose, she was found dead in the bathtub by her parents.

The original autopsies for each the young women revealed no abnormalities and no precise cause of death. With the second girl, the coroner noted cerebral edema and what is called cerebellar herniation – a condition where brain swelling pushes against lower brainstem compressing the region responsible for respiration (breathing) and heart function.  Even though histopathology was done as part of the autopsy, the coroner’s reports provided no indication of which antibodies were used for histology investigations, suggesting only general and non-specific histopathology, making it near impossible to determine if the HPV vaccine was in involved.

Advanced Immunohistochemistry

Without the appropriate immunohistochemical (IHC) examinations, using specific antibodies to tag the antigens used in the HPV vaccine, there was no way for the coroner to determine whether the HPV vaccine elicited or contributed to the deaths of these girls. Knowing this, the current researchers developed a specific IHC to examine the brain tissue and determine whether the vaccine was responsible. What they found was disturbing, but incredibly important.

The IHC from this study found evidence of autoimmune cerebral vasculitis triggered by the HPV16L1 component of the vaccine. HPV16L1particles were identified all over the cerebral vasculature including adhering to the vessel walls. They also observed an increased expression of the complement of immune markers consistent with vasculopathic syndromes. These included:

  • Excessive adhesion of T lymphocytes
  • MHC- II signaling and deposition of immunoglobulin G-immune complexes to cerebral vasculature
  • Increased MMP
  • Intense micro- and astrogliosis

Diagnosing Vasculitis

Diagnosing vasculitis is difficult both because of its rarity, especially in young, previously healthy, individuals and because the constellation of symptoms often mimic other conditions. Blood work, angiography and often a biopsy of the tissue in question are required but not always confirmatory, making this diagnosis as much about clinical expertise as testing.

Once diagnosed, the treatments include, high-dose corticosteroids and sometimes, chemotherapeutic agents.  If diagnosed, it can be treated or at least maintained. The problem, is that currently few physicians are looking at vasculitis as a possible culprit for the range of symptoms exhibited by Gardasil or Cervarix injured young women. This study suggests we should. There are however, dissenting opinions.

Dissenting Opinions and Possible Problems with the Findings

Following the publication of these findings in October 2012, the CDC convened a panel in November 2012 to review the report. The CDC panel  identified concerns with the study methods and interpretation of findings. The working group contends that:

  1. A finding of vasculitis requires evidence of inflammatory infiltrate damage within the vessel wall and that standard histopathology testing (hematoxylin and eosin- H&E stain) stain would have identified said damage. Since the H&E stain was negative, vasculitis was not evident and did not exist.
  2. Details of the authors’ histopathology methods/staining and the appropriate control data (HPV vaccine free brain tissue) were not included, are new, have not been tested and therefore, are not valid.
  3. HPV-16L1 particles are too small to identify using light microscopy, electron microscopy (EM) would have been required. The authors provided no evidence that EM was used. And again, the issue of the lack of control specimen was indicated as a flaw.
  4. Lack of information about alternative causes of death.

Rebuttal of CDC Panel Findings

Comparing apples to oranges. Neither of the two studies the CDC offers as evidence against the finding of cerebral vasculitis involves research on cerebral vasculitis. One of studies cited is a letter to the editor published in the Rheumatology journal reporting two cases of skin vasculitis, post-Gardasil vaccine; evidence that appears to support a linkage between the HPV vaccine and vasculitis in general rather than dismiss it.

The second study cited as evidence against cerebral vasculitis was the CDS’s own study, a 2009 Post Liscensure Gardasil Surveillance Report that reviewed and tabulated the Vaccine Adverse Event Reports (VAERs) data from June 2006, through December 2008. Neither cerebral vaculitis nor other forms of vasculitis was an endpoint or outcome variable evaluated in this study. Using the CDC’s Surveillance report, which neither included the very endpoints in question, nor gathered manufacturer independent data to verify claims to negate the findings cerebral vasculitis, is spurious at best, and disingenuous or worse when one considers the potential risks involved for getting this diagnosis wrong.

Technical and methodological criticisms. The technical criticisms against the cerebral vasculitis findings involve utilizing new, less well understood methods to detect the disease process versus accepted and tools and techniques. Only time and additional testing will tell whether these concerns are valid. This was a preliminary study, to reject it based on its newness and novelty, particularly when the risks are so high, seems unwarranted. Instead, additional research should be undertaken immediately to confirm or reject the claims and to validate or invalidate the methods.

No control data. This is a red herring, used against some studies when necessary and dismissed in others when it suits the critic. Other highly praised Gardasil studies, for example, find it perfectly acceptable to have no controls groups. Certainly, a control group would be ideal, but in preliminary case reports it is not necessary. The authors of the study in question address the lack of control subjects and recognize the need for additional research. It should be noted, however, that postmortem brain tissue analysis in young, healthy women is not common and it would be difficult to determine what was ‘normal’ versus abnormal. Again, rather than reject the findings of cerebral vasculitis outright, additional testing should begin to validate or invalidate these findings.

Is Cerebral Vasculitis or Vasculitis Linked to the HPV Vaccines?

At this point it is not clear, additional research is needed. However, the clinical presentation of adverse reactions appears to support cerebral and other regional vasculitides. Together with this preliminary postmortem tissue evidence, not only does the vasculitis linkage warrant additional investigation, I feel it should it be included in the diagnostic differential, particularly for the treatment refractory constellation of neurological and autoimmune symptoms so commonly reported by vaccine recipients.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

Share

Gardasil Research versus Marketing: The Reality of One Less

1306 views

Back in 2006 when the Gardasil commercial first aired, the marketing mavens at Merck had us all humming along about how we wanted to be ‘one less.’ Now – 7 years and a myriad of articles, claims and additional research later, the question remains; what does it mean to be ‘one less’ and is it worth the price?

What is Gardasil? Gardasil is a vaccine approved by the FDA and recommended by the CDC as a preventative measure against four strains of HPV that are known to cause 70% of cervical cancer cases and 90% of genital warts. The vaccine must be administered over the course of a year via several injections. It is recommended for those who are not yet sexually active (i.e. younger girls, aged 9-12).

What is HPV and how is it related to Cervical Cancer? There are over 100 strains of HPV (Human papilloma virus) with approximately 30 of them being sexually transmitted. Research has found that, in rare cases, approximately 10 of those 30 strains can lead to cervical cancer. Most women are diagnosed with HPV via an abnormal Pap test. There is no cure for HPV and in most cases the infection goes away and the virus remains dormant within the body.

It is estimated that at least 20 million people in the US already have HPV; with about 50 percent of sexually active men and women at risk for acquiring a genital HPV infection during their lifetime. According to the CDC every year in the United States, about 10,000 women develop cervical cancer, and 3,700 die from it. Although cervical cancer is the second-leading cause of cancer deaths among women around the world, it ranks between 15th – 17th for cancer death in developed nations such as the US and Australia.

What do we know about the effectiveness of Gardasil? Unfortunately, the answer is not much. Despite information put forth by the US CDC, Health Canada, Australian TGA, and the UK MHRA, the efficacy of Gardasil in preventing cervical cancer has not been demonstrated. According to an article published in the Annals of Medicine, the longest follow-up data from phase II trials for Gardasil are on average 8 years. However, invasive cervical cancer takes up to 20 – 40 years after initial infection to develop into cervical cancer.  Currently the death rate in the US from cervical cancer, according to World Health Organization (WHO) data (1.7/100,000), is 2.5 times lower than the rate of serious adverse reactions from Gardasil as reported by the Vaccine Adverse Event Reporting System (VAERS) (4.3 per 100,000 doses)

Since the vaccine is so new, and follow-up trials less than a decade old, the long-term health risks of Gardasil are still widely unknown. Adverse side effects have included death, convulsions, syncope, paraesthesia, paralysis, Guillain–Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.

Is it worth the cost? The vaccine only works against 4 HPV strains and annual pap screens are still needed to detect cervical cancer.  The full injection sequence costs an approximate 400 USD, which is more than the cost of a pap screen. This nullifies any cost savings from the vaccine. In countries where cervical cancer deaths are the highest (Uganda, Nigeria, Ghana), the cost of Gardasil makes it an nonviable option. Current research suggests that by targeting other risk factors such as smoking, the use of oral contraceptives and chronic inflammation in conjunction with the already recommended and proven effective annual Pap test, global minimization of cervical cancer is likely – at equivalent or higher rates than those hypothesized for Gardasil.

For now, until more is known on the effectiveness and risks of Gardasil it may be better to be one more who goes for their annual exam and partakes in safe sexual practices than being an undetermined ‘one less.’

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

Share

Gardasil: The Controversy Continues

2884 views

You have an 11 year old son or daughter. You go to the doctor for a physical or broken bone and he/she recommends a shot for the human papillomavirus or HPV. The name alone sounds horrifying, but then they tell you that this virus causes genital warts and [gasp] cervical cancer. You immediately want to surrender to whatever it is that the doctor is suggesting in order to protect your child. While HPV is the virus that causes these two medical problems, they leave out the fact that there have been many serious side effects, including death, linked to the vaccine. Here are some more interesting facts that I previously reported in Gardasil, Miracle or Deadly Virus?:

  • Researchers have identified 100 different strands of the virus, the Gardasil vaccine only protects against 4.
  • Sexually active individuals have an 80-85% chance of being infected with one of the identified 100 strands of the virus in their lifetime.
  • A healthy body can fight off the infection 80% of the time.
  • With early detection, thanks to the annual pap smear test, cervical cancer can be detected and successfully treated. In 2008, the CDC reported that 12,410 women in the US were diagnosed with cervical cancer. Only 4,008 women in the US died from cervical cancer.

We all want the best for our children. Most parents here the words cancer, genital warts and immediately jump to the conclusion that this vaccine was approved so it must be safe. However, according to the Vaccine Adverse Event Reporting System (VAERS) on the Center for Disease Control (CDC), where parents and patients can report adverse effects of any vaccine, “over 25 million doses of Gardasil and there was an average of 53.9 VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.” The ongoing controversy of how much of these reported side effects are mere coincidence or a direct correlation can’t be measured on the self-reporting site, but consider this:

As a parent or young adult does the risk of a 6.2 percent chance of a serious side effect to protect your child or yourself from 4 out of 100 strands of a virus that the body can fight 80 percent of the time worth it? What’s more, for the 20 percent of patients that will not be able to fight it off on their own, it is usually caught during an annual pap smear test and treated before causing any major threat to the individual’s health.

Why the controversy? Mainstream media touts that the benefits outweigh the good, while alternative news sites and blogs tell of the horrific side effects that ruined or took or ruined their daughters’ lives (and now it is recommended for boys as a preventative measure as they carry the virus). How do you decide what is best? The important thing to remember is that it is your decision. Look into all the research and decide the risk factors of both getting it and not getting it. Here are some important things to look into as you investigate.

Follow The Money

The US is one of the few countries that allow pharmaceutical companies to advertise on television. The broadcasting company that is paid by advertising revenues is probably not going to disapprove of a product that one of their advertising clients is selling in between news segments. Furthermore, Merck paid doctors to promote the vaccine. Health Impact News Daily estimates that Merck legally paid approximately $2,313,942.81 to doctors to promote Gardasil. How can we trust the doctors on the news to be trustworthy and not one of Merck’s paid advertisers? Talk to doctors you trust and ask them if they were paid to promote the vaccine. Get a second opinion, or even a third.

Furthermore, the following medical associations that promote the vaccine also received funds from the vaccine makers according to the Journal of the American Medical Association:

  • The American College Health Association
  • The American Society for Colposcopy and Cervical Pathology
  • The Society of Gynecologic Oncologists

Why Is It A Law?

Some states tried to mandate the vaccine as a law. Personally, I don’t believe any vaccines should be mandated by law, but especially one that is under as much scrutiny as Gardasil. Taking a closer look at the politicians who did, let’s again follow the money trail. Texas Governor Perry passed the law to mandate the HPV shot shortly after Merck contributed $6000 dollars to his campaign (amongst other ties to Merck); in California, Merck donated $39, 500 to legislators voting yea on AB 499 according to Cal Watch Dog. For more information on whether or not it is mandated in your state, please read Is Gardasil Mandated in Your State? for more information. You can get exemptions forms for mandated vaccines here.

The Billion Dollar Question – Does It Work?

In 2011, Dr. Diane Harper, lead developer of the Gardasil vaccine came out in a press release stating,

“The best way to prevent cervical cancer is with routine Pap screening starting at age 21 years. Vaccination cannot prevent as many cervical cancers as can Pap screening. Pap screening with vaccination does NOT lower your chances of cervical cancer – Pap screening and vaccination lowers your chances of an abnormal Pap test. Gardasil® is associated with GBS [Guillian-Barre Syndrome] that has resulted in deaths. Pap screening using a speculum and taking cells from the cervix is not a procedure that results in death. Gardasil® can be offered along with Cervarix® as an option to prevent abnormal Pap test results in those women who can make an informed decision about how much they value this benefit compared to the rare risk of GBS. If a woman has no access to Pap screening, receiving HPV vaccines may help reduce cervical cancer IF the vaccines last long enough. At this time, Gardasil® is proven to last for at least 5 years, and Cervarix® for at least 8.5 years. Health policy analyses show that there will be no reduction in cervical cancer unless the vaccine lasts at least 15 years.”

Not good press for either Merck or GlaxoKlineSmith, the maker of the HPV vaccine Cervarix. Currently, there are not booster shots of either vaccine, and the shot is highly recommended for children 9-12 because they are less likely to already have been exposed to the virus. Doing a little math, that means the vaccine will wear off around the ages of 14-20.5 (depending on which brand was administered) very likely prior to sexual activity! What’s worse is that prior to approval Merck informed the FDA that  if a person has already been exposed to HPV 16 or 18 prior to injection, then Gardasil increases the risk of precancerous lesions, or worse, by 44.6 percent.

The War Wages On

Conventional media and Merck sponsored doctors continue to promote this vaccine, while individuals and alternative news sites continue to warn the public against it. For mothers like Tracy Andrews, the war will never end. Her daughter is one of the unfortunate victims of the Gardasil shot who is permanently disabled because of it. Tracy and her daughter, Alexis, passionately advocate to parents and young adults not to get this vaccine. Together, they also fight to have this vaccine banned. Their story was featured on Lucine and they will also be featured in the upcoming documentary “One More Girl.” This documentary by ThinkExist Productions, plays on Gardasil’s advertising slogan “One less.” The documentary title means “one more girl affected by Gardasil,” while the Gardasil campaign means “one less person affected by HPV.”  The documentary is scheduled to be released in the spring 2013. A preview can be viewed here.

To Vaccinate Or Not To Vaccinate, That Is The Question

In the end, you should discuss the pros and cons with your medical professional and decide for yourself and your family what is best. Arm yourself with as much information as you can so you won’t be intimidated by scary words like “cancer” and “genital warts” and can make an informed decision.

Hormones Matter is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

 

By Jan Christian @ www.ambrotosphotography.com  Gardasil_vaccine_and_box.jpg: Jan Christian @ www.ambrotosphotography.com derivative work: Photohound [CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0), CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0) or CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0)], via Wikimedia Commons

Share

Wal-Mart to Offer HPV Vaccine

846 views

Now, in addition to low priced groceries and other goods, your local Wal-Mart will offer nurse kiosks ready to inject you or your child with a variety of vaccines. Wal-Mart is joining other stores, like Walgreens and CVS, in offering walk-through health clinics. According to recent reports, Wal-Mart will be the first to offer the controversial HPV vaccines Gardasil and Cervarix.

At Hormones MatterTM, we have written a lot about Gardasil and the HPV vaccine questioning its safety. Gardasil: Miracle or Deadly Vaccine?, Is Gardasil Mandated in Your State?, What About the Pap Smear?. For a very heartbreaking story at the dangerous side effects of this story please read A Ruined Life from Gardasil. HPV is a very common virus that many experts believe the body can fight off by itself; with annual pap smear tests a doctor can easily catch and remove any abnormal cells before they become cancer.

The trend of selling direct-to-consumer vaccines, like that of selling over-the-counter medications is time-saving and logical on the one hand, but is troubling on the other, especially with vaccines and medications that have less than stellar safety profiles. Any product sold direct-to-consumer comes with the false presumption that it is entirely safe. Indeed, we have consumer protection agencies to ensure that this is the case with most products. Consumers often mistakenly assume that over-the-counter medications are safe because there is a consumer protection agency protecting their well-being, otherwise the product would not be on the market. Unlike a toy with a choking hazard or a product batch with a chemical contaminant, where the cause and effect are obvious and easily remedied with recall, the direct side-effects or adverse reactions of medications or vaccines are difficult to recognize and more difficult to prove, even under the most regulated of circumstances. When medications or vaccines are sold over-the-counter, it is nearly impossible.

The over-the-counter vaccines effectively remove any ability for physicians, researchers or patients identify side-effects. Selling over-the-counter vaccines is a boon to the pharmaceutical industry, however. With this single move the industry can sell more vaccines, the vaccines become safe in the eyes of the consumer while the industry removes the ability to prove otherwise, and a brilliant, albeit less than ethical, corporate strategy is pushed on consumers.

What do you think, should vaccines be available at the local pharmacy?

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

Share