HPV

Save the Pap Smear! A DES Daughter’s Perspective on Cervical Cancer and the HPV Vaccine

6956 views

DES daughters have unique credentials and knowledge regarding cervical cancer. We have become cervical cancer “experts” based on our own shared experiences and through our knowledge of DES research. We also have the advantage of acquiring this knowledge about cervical cancer before HPV was even detected; and before HPV tests and HPV vaccines were developed.

We know that there are two main types of cervical cancer: the slow-developing squamous-cell cancer (squamous carcinoma); and the much more aggressive glandular-cell cancer (adenocarcinoma). We know because we are at higher risk of both types.

In retrospect the DES story is a result of serendipity, a confluence of very specific and unique circumstances. DES emerged as a public health crisis in 1971 when it was discovered that DES daughters were at risk of an aggressive, glandular cancer of the cervix/vagina because of their in utero exposure to DES.

In a strange way it was actually fortunate that the ‘DES cancer’, clear cell adenocarcinoma of the cervix/vagina, was so unexpected and so shocking that it was noticed by clinicians, i.e. a rare virulent cancer previously only seen in post-menopausal women was suddenly being diagnosed in young women and girls.

It was also fortuitous that these cancer cases were located in a very specific geographical region- a particular hospital, the Vincent Memorial Hospital, in Boston. The original and most influential promoters of DES as a pregnancy maintenance treatment were The Smiths of Boston: Dr George VS Smith, Head of the Gynecology Department at Harvard University Medical School from 1942 to 1967; and his wife Dr Olive Watkins Smith, a biochemist. The ‘DES Cancer’ was originally known as ‘The Boston Cancer’

In retrospect, it was also fortunate that the use of DES during pregnancy was always controversial and that clinical trials were undertaken in the early 1950s. In fact one to the earliest large-scale, prospective, double-blind, randomised clinic trials (RCT) reported in the medical literature was conducted on DES and involved 2,000 women.

As a result of these circumstances – the sentinel finding of the ‘DES Cancer’; and the existence of research cohorts that could be reassembled – there has been follow-up in the USA into the long-term adverse outcomes of DES exposure. The cohorts of these original RCTs were reassembled providing a strong research tool – DES mothers could be compared to mothers in the control group; DES daughters with the control group daughters; DES sons compared to the control group sons.

The DES Cancer: A Decades-Long Side Effect

The ‘DES Cancer’ finding sent shock waves through the medical science community. Up until this time, based on the Thalidomide tragedy, it was believed that any adverse outcomes to a drug would be evident soon after the exposure, as in “birth defects”. With DES and clear cell adenocarcinoma of the cervix/vagina, the adverse outcome was expressed decades after the exposure.

It was found that the timing of the DES exposure was critical; and, using mice, researchers were able to examine more precisely the effect of timing and dose. The mouse is a valid model as the differentiation stages of the reproductive tract is similar and comparable to that of a human. By correlating both dose and time of exposure, researchers were able to replicate in mice the adverse health outcomes found in the human DES population. A 1981 landmark publication, Developmental Effects of DES in Pregnancy edited by Arthur L. Herbst and Howard A. Bern, brought together leading experimental researchers and expert DES clinicians.

DES - Herbst, Berne study

And this collaboration continued. The DES experience was central to the development of the scientific endocrine disruption paradigm. DES is the primary model for environmental endocrine disruptors.

From Lessons learned from perinatal exposure to diethylstilbestrol

“The synthetic estrogen diethylstilbestrol (DES) is well documented to be a perinatal carcinogen in both humans and experimental animals. Exposure to DES during critical periods of differentiation permanently alters the programming of estrogen target tissues resulting in benign and malignant abnormalities in the reproductive tract later in life.

Using the perinatal DES-exposed rodent model, cellular and molecular mechanisms have been identified that play a role in these carcinogenic effects. Although DES is a potent estrogenic chemical, effects of low doses of the compound are being used to predict health risks of weaker environmental estrogens. Therefore, it is of particular interest that developmental exposure to very low doses of DES has been found to adversely affect fertility and to increase tumor incidence in murine reprodu ctive tract tissues. These adverse effects are seen at environmentally relevant estrogen dose levels.

New studies from our lab verify that DES effects are not unique; when numerous environmental chemicals with weak estrogenic activity are tested in the experimental neonatal mouse model, developmental exposure results in an increased incidence of benign and malignant tumors including uterine leiomyomas and adenocarcinomas that are similar to those shown following DES exposure.

Finally, growing evidence in experimental animals suggests that some adverse effects can be passed on to subsequent generations, although the mechanisms involved in these trans-generational events remain unknown.

Although the complete spectrum of risks to DES-exposed humans are uncertain at this time, the scientific community continues to learn more about cellular and molecular mechanisms by which perinatal carcinogenesis occurs.

These advances in knowledge of both genetic and epigenetic mechanisms will be significant in ultimately predicting risks to other environmental estrogens and understanding more about the role of estrogens in normal and abnormal development.”

From another study looking at the role of endocrine disrupting compounds and developmental timing on female reproductive disorders:

“The ability of synthetic chemicals to alter reproductive function and health in females has been demonstrated clearly by the consequences of diethylstilbestrol (DES) use by pregnant women…. The daughters of women given treatment with DES were shown to have rare cervicovaginal cancers. Since the initial 1971 publication linking treatment of women with DES and genital tract cancers in offspring, other abnormalities have been observed as the daughters have aged, including decreased fertility and increased rates of ectopic pregnancy, increased breast cancer, and early menopause. Many of these disorders have been replicated in laboratory animals treated developmentally with DES. The lessons learned from 40 years of DES research are that the female fetus is susceptible to environmentally induced reproductive abnormalities, that gonadal organogenesis is sensitive to synthetic hormones during a critical fetal exposure window, that reproductive diseases may not appear until decades after exposures, and that many female reproductive disorders may co-occur.

Other synthetic chemicals used in commerce are known to mimic hormones and have been shown previously to contribute to disease onset. These chemicals are called endocrine-disrupting compounds (EDCs). Endocrine-disrupting compounds are either natural or synthetic exogenous compounds that interfere with the physiology of normal endocrine-regulated events such as reproduction and growth. Although there are many hormonal pathways through which EDCs can act (e.g., agonists or antagonists of steroidal and thyroid hormones), many of the reported EDC effects in wildlife and humans are caused through alteration of estrogen (E) signaling. This is because E signaling is evolutionarily conserved among animals and is crucial for proper ontogeny and function of multiple female reproductive organs

The purpose of this article is to establish the state of the science linking EDC exposures to female reproductive health outcomes. After introducing several topics crucial to understanding the etiology of female reproductive disorders, we present an overview of ovarian, uterine, and breast development, as well as how exposure to EDCs may contribute to some of the most prevalent reproductive disorders in these organs and to pubertal timing. Emphasis is placed on the period of development that currently is known to be most susceptible to disruption and harm by exposure to EDCs. To conclude, we present both specific research needs and several general initiatives needed to improve women’s reproductive health.”

DES Mothers and Breast Cancer

Another example of serendipity concerns the discovery that DES mothers have a higher incidence of breast cancer because of their DES exposure. When the ‘DES Cancer’ was discovered, DES Follow-up clinics were established for DES daughters to attend for the recommended special examination. The nurse in charge of one of these clinics, on chatting to the DES daughters before they had their examination, was struck by the number of daughters who were upset that their mothers had been diagnosed and/or died from breast cancer. This anecdotal observation led to research being carried out and the 1984 publication Breast cancer in mothers given diethylstilbestrol in pregnancy.

The findings were that DES mothers were 40 to 50% more likely than the control group to develop breast cancer. The authors noted a trend that the DES mothers developed the cancer at an earlier age; and that they developed a more aggressive form of the disease with a higher mortality rate.

This finding was further confirmed with animal modelling. Of course it has been known for decades that DES caused mammary cancer in experimental animals. As pointed out by Pat Cody in DES Voices: From Anger to Action (2008),  animal studies dating from the 1930s showed that oestrogen administered to animals – cats; guinea  pigs; monkeys; rabbits; and especially in what came to be the favoured mammals, mice and rats – showed reproductive tract malformations and cancer.

DES was synthesised in 1938 by a team of scientists in England, headed by Sir Charles Dodds. Later in 1938 Dodds reported that orally active oestrogen, including DES, interrupted early pregnancies in rabbits and rats. In 1938, a French researcher reported that male mice treated with DES developed breast cancer.[Lacassagne A (1938) Apparition d’adenocarcinoma mammaires chez des souris males traitees par une substance oestrogene synthetic. Comptes Rendus Biol. (Paris) 129.]

As explained in Barbara Seaman’s highly recommended book The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth (2003), Dodds was aware of what a powerful and potentially carcinogenic drug he had synthesised. In the months following the discovery Dodds became increasingly concerned about the carcinogenicity of the newly synthesised drug. In his laboratory he noticed that men on his staff who handled the stilboestrol powder were growing breasts, suggesting to him stilboestrol might cause breast cancer in men. He suggested that animal studies be carried out looking at the carcinogenicity of stilboestrol in male rodents. In 1940 a paper was published showing that stilboestrol caused mammary cancers in both male and female mice.

DES: Not One but Two Cervical Cancers

That DES daughters also had a higher incidence of squamous-cell abnormalities (when compared to the control group) was recognised quite early on. At the same time it was reported that DES daughters suffered much higher rates of cervical stenosis following minor procedures.

In the early years many of us purchased medical dictionaries and headed off to medical libraries to look at source material. DES Action has always strived to make information contained in medical journal articles accessible to our members. We have a long history of sharing information, reviewing journal articles and explaining terminology, thus empowering members to make informed decisions about their health care. The issue of how to treat dysplasia was featured in our newsletter DESPATCH a number of times. For example, DESPATCH No. 9 November 1982, looked at dysplasia treatment options and cervical stenosis, and explained the terminology.

DESPATCH No.9 p.1

I think our introduction to this edition of DESPATCH is worth repeating:

“The actual changes that DES exposure causes are quite complex. As a result of this, a DES daughter not only has to cope with the actual screening examination, but with an entirely new language.

This issue of DESPATCH is rather dry and technical: We concentrate on defining terms and de-mystifying the jargon. However, it is important that you are not intimidated by the jargon. Remember a true expert will not hide behind jargon but will be able to explain things simply and clearly. So, if you don’t understand what the doctor is saying, say so and ask that it be explained again….and again!”

It was hypothesised that the DES-related structural changes in both the cervix and uterus may be associated with connective tissue alterations that predispose to abnormal healing and increased propensity to cervical stenosis. Therefore the recommended management of DES daughters with these squamous-cell abnormalities was monitoring with minimal intervention. Those of us who knew we were DES exposed, and were attending DES follow-up screening clinics, were in the privileged position of having expert monitoring without intervention.  And that is why many DES daughters have personal experience of even high-grade squamous-cell abnormalities resolving over time without any treatment.

That’s not to say it was easy, particularly in the early years. Often we were being called back for 3 monthly checks. But as time passed, and we experienced that the abnormalities ‘matured’ or resolved, we became more relaxed about squamous-cell abnormalities.

We used to joke that discussing cervix status seemed to be almost a defining feature of our group –  nowhere else you could comfortably talk about the state of your cervix.

As I said we were in a privileged position of having expert screening with clinicians who explained and discussed issues. Over the years I’ve had three occasions when the clinician noted that “according to the textbook” he should probably do a biopsy but, as he was confident it would resolve, he would leave it. As I knew he was an expert, and that he was referring to squamous-cell abnormalities, I was happy to go along with this suggestion.

Of course lurking in the background was the knowledge that we have a life-long risk of the ‘DES Cancer’, clear cell adenocarcinoma of the cervix/vagina.  Initially we were screened every 6 months, but then it went to annual checkups.

DES Daughters and the HPV Vaccine

So when there was news of a ‘cervical cancer vaccine’ being developed, we naturally were very interested and read up on it. However, the more we read, the less sense it made. When we realised it was for squamous-cell cervical cancer, the unanimous opinion was “Why bother?!’  It wasn’t even a cervical cancer vaccine, but a HPV vaccine (or, to be pedantic, a ‘HPV strains 16 and 18’ vaccine).

Why would you bother having a part-HPV vaccine when we knew through experience that even high-grade squamous-cell abnormalities usually resolved spontaneously without any intervention?

The vaccine was designed to prevent the very abnormalities that empirical evidence of the National Cervical Screening Program (NCSP) showed would resolve anyway – crazy. We looked on in bemusement at the HPV hysteria that erupted in 2006. It was an extraordinary example of manipulating the media for commercial gain when the drug manufacturer orchestrated the listing of Gardasil on the Pharmaceutical Benefits Scheme and the National Immunisaton Program.

This battle to list the HPV vaccines, and how commercial pressure and political opportunism threatened the independence of Australia’s healthcare system, is discussed in Healthcare’s Sticking Point.

It was a classic textbook example of disease mongering: Take a common, essentially benign condition (HPV infection) and it suddenly and only becomes “serious” or “life-threatening” when Big Pharma has a product to sell (i.e. HPV vaccine).

It was disgraceful that public health money was diverted into the HPV industry. In terms of women’s health, it would have been more productively spent on education programs and publicity campaigns on the value of Pap smears, in order to raise the participation rate of the NCSP; or on research into a screening test for ovarian cancer.

All we could do was shake our heads in bewilderment: If the government wanted to waste billions of dollars on a school-based vaccine program of unproven value, so be it. At least there was the safety net of the NCSP and women having regular Pap smears.

And now that is under threat. The proposed changes to the NCSP, due to be implemented on 1 December 2017, is that HPV testing has been fast-tracked to become the primary cervical screening tool; that the commencement age be raised to 25 years; and the screening interval be extended to 5-yearly.

This is a public health crisis in the making. There are two type of cervical cancer and the proposed policy is focused on just one. It is modeled exclusively on squamous cancer and ignores empirical evidence from the NCSP that glandular cancer now represents approximately 30% of cervical cancers diagnosed in Australia today.

This will put the lives of women, particularly young women, at risk.

As there appears to be a push worldwide to introduce this screening regimen (HPV testing as the primary cervical screening tool; commencement age 25 years or later; and 5-yearly screening intervals) potentially millions of women are at risk. It could be a medical and public health disaster on a scale never before seen.

If the DES experience teaches us anything, it is to remain vigilant about the efficacy and safety (both short-term and long-term) of pharmaceutical products, and this includes vaccines. It involves understanding the different types of cervical cancer; understanding the various risk factors, including HPV and endocrine disruptors; and being informed about the benefits and limitations of the screening tests, such as the Pap smear and the HPV test.

Stay with us, as we cover each of these topics over the next few weeks.

DES Daughters, Sons, and Grandchildren – Share Your Story

If you are the daughter, son or grandchild of a woman given DES during pregnancy, please share your story with us.

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.

This article was published originally on May 1, 2017.

Photo by Ernest Karchmit on Unsplash.

Share

Death by a Thousand Cuts: Vaccines, Non-Profits, and the Dissemination of Medical Information

4076 views

The vaccine debate and prying into Planned Parenthood’s Standard Operating Procedure are two arenas I have not gravitated toward. Genetically engineered crops, industrial farming, confined animal feeding operations (CAFOs), dams killing wild salmon, these are my fortes. The news daily is like death by a thousand cuts for me tied to new studies on collapsing ecosystems, indigenous people fighting against mines and other extractive industries, and more and more on climate change.

I never thought I’d be embroiled in a fight for my livelihood because I lightly questioned the efficacy of rampant vaccination of girls (and now boys) with the Merck-marketed HPV vaccine, Gardasil. To date, more than 270,000,000 doses have been distributed worldwide with the HPV vaccine (World Health Organization’s Global Advisory Committee on Vaccine Safety), both the GlaxoSmithKline and Merck versions.

My story started when I was in a Planned Parenthood training, a mandatory course for social workers titled Fundamentals of Sex Ed. For a total of possibly 30 seconds out of a 16-hour two-day training (I was kicked out after day one), I voiced my opinion about the potential risks associated with Gardasil. On a slip of paper, then, in an anonymous forum, I went further with about 60 words answering this first day evaluation question: What could Planned Parenthood have done differently today in the training?

I am really disappointed that Planned Parenthood in Seattle is so lock-step in line with Big Pharma. Especially in the case of Gardasil, which is a vaccine that has gotten tens of thousands complaints about it. Anyone, including my 16 to 21 year old clients, could easily Google ‘Gardasil Dangers’ and find a plethora of very disturbing and legitimate information about its dangers. I wish Planned Parenthood showed more critical thinking and independent pedagogical standards, including informed consent.

Less than two hours after the training, I was called at my hotel room by my supervisor, who let me know:

The Planned Parenthood trainers said they do not want you back for the second day of training. I am putting you on administrative leave. I am looking into what happened in Seattle. Do not return to the office until further notice.

That was Oct. 15, and I have since been terminated, have been on the job market, am attempting to collect a few weeks of unemployment assistance, have a lawyer investigating my case, and started writing about my case on multiple forums. You can read my posts: Gardasil and the American Bald Eagle – What Would Rachel Carson Do?, My Fate as a Social Worker Sealed by a Vaccine Named GardasilPlanned Parenthood, A VaccineDouble-think Alive and Well in the World of Non-profits.

The Sordid History of the HPV Vaccine Marketing

I have collected a hundred reports, articles, documentaries and blogs tied to the HPV vaccine, which has been in use since 2006. The treasure trove is enlightening, intimidating, depressing and validating. Every drug and chemical in the world should have this amount of scrutiny, preferably before it is released, and yet, the depressing part is that these chemicals get very little advance review and once introduced into our systems of medicine, food production/ processing, and modern industrial existence, the unintended consequences and synergistic downsides are more difficult to elevate to a level of grave public concern. Indeed, it often takes 20 years before the FDA will take action and the lessons of our folly reaches clinical care. Why so long? Perhaps it has to do the intense marketing of these chemicals.

The PR firms, legal teams, government agencies, law makers, and politicians all have a stake in the game with billions of dollars in profits at stake. In fact, the pharmaceutical industry is the single largest contributor to congressional accounts in the United States, spending almost 4 billion dollars annually in lobbying efforts, more than double the spending of the defense industry. This is, of course, in addition to the many millions more spent on marketing their products. The issues whirling around Gardasil represent a microcosm of all that is wrong with our healthcare industry. It is difficult at best and impossible for most to speak out against the power purchased with these multi-million dollar budgets. For citizens, consumer groups, watchdog agencies or journalists going against the grain, the road to hell is paved with threats, lawsuits, and vitriol. We are labeled conspiracists, Luddites, anti-science extremists and crazies or nuts.

Fact is Stranger than Fiction

What I am finding in my own nascent life tied to Gardasil and Planned Parenthood is a type of bearing witness, knowing there are deeper and more layered and nuanced ways of looking at the mad men in advertising, marketing, propaganda and more existential ways of contemplating the insanity of unlimited growth, the consumer assault and battery from the merchants of death. Decades ago, Rachel Carson wrote:

The crusade to create a chemically sterile, insect-free world seems to have engendered a fanatic zeal on the part of many specialists and most of the so-called control agencies.

She believed that she was living in an era

…dominated by industry, in which the right to make a dollar at whatever cost is seldom challenged. When the public protests, confronted with some obvious evidence of damaging results of pesticide applications, it is fed little tranquilizing pills of half-truth. We urgently need an end to these false assurances, to the sugar coating of unpalatable facts.

The cross-pollination of a huge marketing campaigns with scientists and medical companies and pharmaceuticals is both bizarre and business as usual. Here, in 2006, from one of those marketing firms:

More than 95 insurance plans–covering 94 percent of insured individuals–have decided to reimburse Gardasil, according to Merck. The Centers for Disease Control and Prevention has also added the vaccine to its Vaccines for Children Contract, making it available to Medicaid-eligible, uninsured, under-insured, or Native American children up to the age of 18.

Analysts are optimistic about the vaccine’s market potential. “It’s very clear that patients are going to be interested in it,” said John Lebbos, MD, therapeutic area director of infectious diseases at market research firm Decision Resources. “From what I’ve seen, it’s going to be a blockbuster.”

Education about the vaccine is going to be a critical piece–due both to a lack of understanding about HPV as well as early controversy that vaccination might lead to teen promiscuity.

Note the terminology of the purveyors of capital and profit-making health care: “vaccine’s market potential” and “it’s going to be a blockbuster.” These are the sentiments of a physician whose Hippocratic oath states first do no harm. More importantly, these are the sentiments that drive our healthcare industry. It is profit driven, not necessarily health driven, and therein lay one the many problems associated with the promotion of medications, vaccines, and/or environmental chemicals; profits and health need not align.

Setting the Stage

From the onset of Gardasil, after the fast-tracked shoddy FDA approval (Examining the FDA’s HPV Vaccine Records), Merck deployed the services of one of the world’s more powerful propaganda firms, AKA PR outfits:

The PR genius behind all stages of Merck’s HPV and Gardasil campaigns is the PR giant Edelman. The world’s largest independent PR firm, Edelman boasts more than 2,100 employees working in 46 wholly owned offices worldwide, plus the additional resources of more than 50 affiliates. Apparently Merck is hoping that most, if not all the states in the US, will mandate a vaccine against HPV as a pre-requisite for school attendance. And beat rivals to it, before GlaxoSmithKline gets FDA approval for its Cervarix.

In the dozens and dozens of articles in the New York Times, in reports by PR Watch and Judicial Watch, scant few mentioning of the untold physical incapacitation, chronic illness and deaths tied to Gardasil by many citizen groups with some scientists behind the calls to stop the Gardasil-Cervarix mass vaccination program (TruthWikiUS Court Pays $6 Million to Gardasil Victims Judicial Watch:a, bc, Are You Concerned Over Genetically Modified Vaccine? HPV Researchers, Planned Parenthood Win Prestigious Lasker Medical Awards).

But, 11 years ago, even before FDA approval, Merck and Edelman were on the PR war-path beating the cervical cancer drums:

Merck used its deep pockets to make sure that even before the FDA had approved Gardasil, there was a growing awareness of and concern about HPV and its link to cervical cancer. According to Bloomberg News, Merck spent $841,000 for Internet ads alone relating to HPV in the first quarter of 2006 — months before the FDA had even approved Gardasil (Part One: Setting the Stage).

Drug Marketing through Non-Profit Support and Favorable Legislation

How does this marketing affect the non-profit sector? A report in the New England Journal of Medicine found that “83 percent of the nation’s 104 largest patient advocacy groups take contributions from the drug, medical device and biotech industries,” and “one-fifth of the patient advocacy groups studied accepted $1 million or more from drugmakers, but exactly how much those groups accepted is fuzzy.” It is fuzzy because non-profit funding streams are not disclosed and/or are purposefully channeled through pharma subsidiaries in order to obfuscate obvious connections. If the organization’s existence depends upon funding from a product manufacturer, is it unreasonable to assume that the organization might be beholden to the views of their funders? I don’t think so. Check out the interview with one of the world’s richest men’s son, Peter Buffet, on the Charitable Industrial Complex here: My talk with Peter Buffett ,Warren Buffett’s son, about what’s wrong with philanthropy.

Here’s just one example of non-profit collusion with the pharmaceutical companies and health care for-profits. This is a three-part series written for PR Watch in 2017 by journalist Judith Siers-Poisson:

According to their website, “Women in Government is a national 501(c)(3), non-profit, bi-partisan organization of women state legislators providing leadership opportunities, networking, expert forums, and educational resources to address and resolve complex public policy issues.” The campaigns that they feature on their home page deal with kidney health, Medicare preventive services, higher education policy, and the “Challenge to Eliminate Cervical Cancer,” which was publicly launched in 2004.

On February 2, 2007, Texas Governor Rick Perry, against the wishes of his conservative base and to the surprise of critics, signed an executive order mandating HPV vaccination for girls entering seventh grade. Then, unfortunately for Perry and Merck, details of his many connections with both Merck and Women in Government became public.

Ellen Goodman of the Boston Globe noted, “It turned out that Perry’s former chief of staff is now a lobbyist for Merck. Did that look bad? Whoa, Nellie. Did it look bad that Merck had funded an organization of women legislators backing similar bills? Whoa, Merck.” USA Today reported that Perry’s current chief of staff’s mother-in-law, Texas Republican State Representative Dianne White Delisi, is a state director for Women in Government. Perry’s wife, Anita, a nurse by training, addressed a WIG summit on cervical cancer in Atlanta in November 2005. Perry also received $6,000 from Merck’s political action committee during his re-election campaign.

In 2004, more than 20 WIG funders were pharmaceutical companies or entities heavily invested in health care issues that could come before state legislators. A short list includes both Merck & Co., Inc and Merck Vaccine, GlaxoSmithKline (which will soon have the second HPV vaccine on the market), and Digene Corporation (which manufactures an HPV test). Other drug interests listed as donors to WIG include Novartis, Eli Lilly, AstraZeneca, Bayer Healthcare, Pfizer, Bristol-Myers Squibb (both the company and their foundation), and Pharmaceutical Research and Manufacturers of America, also known as PhRMA, one of the largest and most influential lobbying organizations in Washington representing 48 drug companies.

The funders of Women in Government today, as I am looking at their website, are still those big ones listed above and others in the for-profit health care fields.

So here the pharmaceutical companies funded a non-profit organization that then supported legislators and legislation favorable for the companies and products. By all accounts, a common practice. What happens when they also fund the organizations tasked with providing healthcare, organizations such as Planned Parenthood? Can we tie Planned Parenthood to the makers of Gardasil? I think we can. Here is just an introduction to their funding.

According to a Washington Post article run in August 2015, during the fiscal year that ended June 30, 2014, Planned Parenthood affiliates around the country received $528.4 million in government funds (a combination of state, federal and sometimes local government dollars). Those federal dollars were the single largest source of money coming into the organization and its local affiliates, by far. Another $305.3 million came from non-government sources, about $257.4 million reached the organization after private donors and foundations made contributions and bequests. The organization also raised another $54.7 million in fees charged for its services. Government funding, with federal dollars comprising the biggest portion of this part of the organization’s budget, are absolutely critical to Planned Parenthood’s total operation, but so too are the private funds. How and from whom those private funds come aligns quite clearly with the organization’s view on certain drugs and vaccines. On the surface, this seems perfectly reasonable. Why wouldn’t a private foundation support an organization that aligns with its goals? It would be illogical to support an organization with contrary views. What becomes clear though, once we begin to unravel these connections, is just how deeply entrenched these alliances are. It begs the question, if a significant portion of one’s operational budget comes from a foundation and/or a manufacturer who supports a particular product or set of products, is it possible to question those products in any meaningful way or at all? Probably not.

Just recently, Peter Doshi, associate editor of the British Medical Journal, published a scathing report about the specious relationships between vaccine educators like Every Child by Two, the Immunization Action Coalition and even the American Academy Pediatrics, the CDC and the pharmaceutical industry. Each organization received millions of dollars in funding both directly from the CDC and from industry, and as a consequence, their recommendations regarding vaccines are in lockstep with their funders. When pressed about these relationships and whether any of the organizations had ever questioned the safety or efficacy of the products they recommend, each admitted that they had not.

So just how independent and reliable is the health information put forth both non-profit organizations like Planned Parenthood, who receive their funding from industry or foundations supported by industry? Moreover, how closely must the organization’s employees adhere to the accepted party line? If my case is any indication, pretty damned closely.

Stay tuned for part three in this series, where I’ll detail the complicated and compromising funding sources of Planned Parenthood and its affiliates.

We Need Your Help

Hormones Matter needs funding now. Our research funding was cut recently and because of our commitment to independent health research and journalism unbiased by commercial interests, we allow minimal advertising on the site. That means all funding must come from you, our readers. Don’t let Hormones Matter die.

Yes, I’d like to support Hormones Matter

Bamboo shoots. Photo by David Inouye.

Share

Another Day, Another Death

3159 views

Another Gardasil girl died last month. I didn’t know her, but her mother had written for us a few years back. My heart aches for her family and for all of the other families who have lost loved ones to pharmaceutical industry malfeasance. Sadly, her death is just one more in a long line of deaths attributable to this vaccine. For the industry that profits from this vaccine, her death means nothing.

No one, except her family and friends will suffer for her death. There will be no culpability from the industry that manufactures and distributes this vaccine, none from the governmental agencies that fail to address the safety issues of these medications, none from the doctors who push this and others vaccines and then dismiss the side effects outright leaving parents to navigate the resultant complex illnesses on their own. No one will admit responsibility. How can they? We have all have been fed a heavy diet of ‘vaccines are always perfectly safe’, that injuries and deaths are due to random chance, not the cocktail of toxicants proffered under the guise of herd immunity. Just unlucky I guess, the price to pay for the safety of others.

Vaccines are perfectly safe.

Really?

Forget, of course, that this is foolhardy and that nothing is perfectly safe.

Forget also that industry knows these vaccines are neither safe nor effective, having fudged the trials and post market research, spent billions on marketing to promote the faulty research, and no small sum on astroturfing campaigns, replete with vitriolic trolls and an echo chamber of paid ‘thought leaders‘.

Forget that 70% of major media budgets are funded by the pharmaceutical industry advertising, as are most medical associations, medical education, university and continuing, medical journals, and patient support groups. Health journalism too, receives its fair share of pharma funding.

Forget that the pharmaceutical industry spends more in lobbying politicians than any other industry, including defense.

Forget that the FDA is a revolving door to cushy industry jobs. Approve this or that drug and one is set for life once one’s government affiliation is over.

Forget too that FDA review panels are staffed with industry insiders and that FDA approves 96% of all applications. Can’t imagine how bad a drug has to be in order the FDA to reject it.

Forget that when vaccine side effects began to be recognized en masse during the Reagan administration, industry quickly colluded with governmental agencies to force vaccination and eliminate any liability for themselves. Enter the vaccine courts, where no matter the injury, no matter the negligence or malfeasance, the government foots the bill for industry. What an ideal business model; all products are always safe and if they aren’t someone else covers those costs. Liability? Responsibility? Nope.

Forget all of these things, and yes, vaccines can be considered perfectly safe, side effects ignored, and deaths considered unfortunate matters of coincidence.

Except they aren’t and we shouldn’t forget.

Young women are dying and/or are debilitated to the point of wanting to die, thousands of them, with this one vaccine alone. This is on top of the skyrocketing number of vaccine and pharmaceutical injured children. Did you know that 1 in every 68 children suffers with neurodevelopmental disorders; 1 in 68. That is a staggering statistic that should give us all pause, but mostly, it doesn’t. Neither does the fact that 70% of adults take at least one medication chronically, 50% take two or more, and 20% take five or more medications, or that toddlers represent the largest growing market for psychotropic medications – toddlers! Admittedly, toddlers can be a bit crazy, but do we really, truly believe that toddlers need antidepressants, stimulants, or worse yet, antipsychotics?

With all of these medications and vaccines, are we healthier?

Nope.

In fact, for the first time in generations, we are living sicker and dying younger. But no, we hold tight to the belief that pharmaceutical medicine is working and all of these injuries, illnesses, and deaths are flukes attributable to the vagaries of random chance.

It was a convenient dissonance while it lasted; still is for many. It allowed us to avoid the much starker reality of modern pharmaceutical medicine or modern living in general: that chemistry matters, that toxicants don’t just magically disappear once they enter the body (or the oceans), and that for all of our technological brilliance, we really have no frickin clue what the compound effects of all of these chemicals are. We really don’t. Heck, we don’t even know what most medications do. A study in the British Medical Journal found that only 50% of medications have sufficient data to suggest that they are likely effective. And since we don’t test most medications on women, we really have no idea whether any medications work or induce serious side effects in women.

Pharmaceuticals are chemical toxicants, plain and simple. They are poisons, albeit sometimes necessary poisons, but poisons nevertheless. We don’t call them poisons though. We call them medicines, but the fact remains, poisons don’t become less poisonous simply because we rename them.

Poisons, by their very nature, are designed to kill things, to block things, and otherwise usurp normal biological functions. Poisons do not ‘heal’. They supplant and they override. Neither do they become less poisonous simply because we take them in small doses. In fact, in many cases, it’s with the smaller doses, particularly when taken chronically, that we see the most devastating side effects, the complex multi-system ones that do everything but kill the individual outright. We are dissonant from these concepts, sometimes willfully. The chemistry is complicated, the disinformation dense, and if we’re truthful with ourselves, it’s easier not to know. Until it isn’t.

Knowing all of this, what do we say to the families who have lost love ones to vaccine injury or death or medication injury or death? How do we go about our daily lives knowing the science is corrupted, arguably with intention, and that more will suffer as a result?

I don’t know the answer to either of these questions. All I know is that as a mom, I feel your loss and I am sorry.

We Need Your Help

Hormones Matter needs funding now. Our research funding was cut recently and because of our commitment to independent health research and journalism unbiased by commercial interests we allow minimal advertising on the site. That means all funding must come from you, our readers. Don’t let Hormones Matter die.

Yes, I’d like to support Hormones Matter.

Image by Manie Van der Hoven from Pixabay.

Share

What About the Pap Smear?

4868 views

In 2008, the New York Times noted that pharmaceutical companies made a forceful push to get Gardasil to the public, even though critics were wary that the long-term outcome was unknown. It only took Gardasil six months to be approved after submitting their application to the FDA. The Center for Disease Control recommended the product shortly after, even though it can take years for most vaccines to be accepted.

Adverse effects from the HPV vaccine are already being reported, but other impacts may be less obvious, such as a false notion that the vaccine prevents cervical cancer.

Forgotten Pap Smear

Amid mounting skepticism over the safety and effectiveness of the HPV vaccine, our attention seems to have been drawn away from the cervical cancer prevention method of yore – The Papanicolaou smear, or, as you may refer to it as, the Pap smear.

A British cervical cancer specialist, Angela Ruffle, stated in the New York Times that she was against any fast adoption of Gardasil in England. She was not just wary of adverse side effects from the vaccine, but also concerned about a false sense of confidence that could deter women from getting regular Pap smears, which are still necessary to detect strains of HPV that Gardasil does not vaccinate against. Mrs. Ruffle cautioned that “if we do this quickly and badly, we can cause more deaths.”

Even the lead developer of Gardasil, Diane Harper, underlined the importance of the Pap smear:

“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… 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.”

What the Cell?

When my legs are in stirrups for my pap smear, I’m usually concentrating more heavily on pushing my tailbone down, as opposed to what the procedure actually entails. As it turns out, your nurse practitioner, or doctor, is actually scraping at your cervix to collect a sample of cells.

Yes, they’re scraping at your cervix, but it sure beats Guillian-Barre Syndrome.

The doctor then places the cell sample into a container that will be sent off to the laboratory for inspection. Any abnormalities detected in the cell samples allow doctors to take preventative measures against cervical cancer.

Promoting Fewer Pap Smears

Pap smear views have shifted, though, and in June, the US Preventive Services Task Force (USPSTF) made changes to their 2003 recommendations, calling for less frequent pap tests. Women should now begin Pap testing at the age of 21, with no more than one Pap smear every three years; whereas women were previously urged to begin Pap screening within a few years of becoming sexually active, and obtain a Pap test at least every three years, though more frequent screening was recommended.

The USPSTF changed its Pap Smear recommendations for the same reason it recommended fewer mammograms: The false positive results led to invasive, painful, and costly biopsies that were unnecessary. False positives findings from Pap smears could also result in future pregnancy risks.

HPV is common, but most healthy men and women are capable of eliminating the infection on their own, so detection of HPV does not necessarily lead to cervical cancer. For this reason, the USPSTF recommends against regular HPV screening for women younger than 30 years of age. And if you are 30, you can put off your Pap screening for 5 years if you combine the Pap test with HPV testing.

HPV Testing – The End for Pap Smears?

There is now a Hybrid Capture II High-Risk HPV DNA test that analyzes DNA from your cervix to detect high-risk HPV. A study supported by the Bill and Melinda Gates Foundation found that HPV DNA testing significantly reduced advanced cervical cancer, as well as deaths from cervical cancer.

The low-cost HPV DNA test will have a major impact in developing countries, where cervical cancer results in over 250,000 deaths a year, but the Pap Smear has already reduced the number of deaths caused by cervical cancer to 4,000 per year.

The Pap smear, however, may very well be run out of town now that HPV DNA testing is included in the Affordable Care Act, offering women over 30 HPV testing every three years. Of course, it’s hard to say, since this HPV DNA test only detects 13 types of HPV; and while the types of HPV tested for are high-risk, cancer-causing strains, there are at least 100 different strains of HPV, which means at least 87 strains will not be detected.

Regardless of whether or not Pap screening will be replaced with the HPV DNA testing, it’s important to note that regular screening is necessary to detect and prevent cervical cancer; the HPV vaccine alone does not prevent cervical cancer.

This article was published originally on Hormones Matter in July 2012.

Share

HPV Vaccines are not Effective, Safe or Necessary

4547 views

I was recently invited to present my research on the HPV vaccine at the Euroscicon Controlling Cancer Summit held in London on 12 May 2014. The theme of the presentations was Advances in Cancer Screening and Prevention Research and the paper I presented was titled: HPV vaccines have not been demonstrated to be safe and effective in the prevention of cervical cancer.

HPV Infections Mostly Harmless

In my presentation I provided evidence that HPV infections are harmless and asymptomatic unless specific environmental co-factors are also present. This is why HPV infections should not be feared by the public and why the medical literature states that cancer is a rare outcome from any type of HPV infection. The fact that cervical cancer is a higher risk in developing countries than in developed countries is explained by the presence of environmental co-factors that are necessary for an HPV infection to progress to cancer. These co-factors (risk factors) are more prevalent in the developing countries. The fact that HPV infections are mostly harmless on their own means that vaccinating all women in developed countries (e.g. Australia, US and the UK) results in the majority of women (99%) being on a drug for a disease that they are not at risk of getting. This is not cost-effective and it is also not necessary because the vaccine has not been proven to be safer or more effective than Pap screening combined with surgery.

If the HPV vaccines are proven to have value in years to come it could be offered to women in the high-risk category. That is, women who are exposed to the environmental co-factors that are necessary for an HPV infection to progress to cervical cancer. However, as yet the vaccine has not been proven to be safe or effective in preventing cervical cancer. Currently governments are claiming that because the HPV vaccine targets 2 of the 15+ strains of HPV associated with causing most cervical cancer, it will prevent some cervical cancer, but they have not determined how much can be prevented. This argument is flawed if the majority of women on the drug are not at risk of cervical cancer and if there is already an effective method of preventing cervical cancer in place. In this case, Pap screening combined with surgery is an effective method of prevention (9 out of 10 cancers) and it is risk free and will still be required by vaccinated women.

The Global Harm Associated with HPV Vaccines

Currently there is much global debate about the harm that is being associated with HPV vaccination programs. As of June 2014 Japan has stopped recommending this vaccine until further safety studies have been conducted. India and Utah have also stopped recommending this vaccine and France is considering similar action. In France the use of HPV vaccine was debated in an open scientific forum on 22 May 2014. This forum allowed all stakeholders to present their case to the French parliament. This is the debate that governments and health professionals are not having in many other countries, for example, Australia.  In fact, the Australian government is recommending this vaccine free to all adolescent girls and boys in school programs without a debate about its safety and efficacy in preventing cervical cancer (a non-infectious disease).

HPV Vaccine Adjuvants

The HPV vaccine has two ingredients that are linked to causing infertility. These are sodium borate and polysorbate 80 and the Australian government has not explained why these ingredients are in a vaccine that is being recommended free to adolescents. This vaccine also has three times as much aluminium hydroxyphosphate sulphate (an adjuvant that is linked to autoimmune diseases and hypersensitivity) as any other vaccine and three times as many adverse events have been reported to this vaccine. The most common adverse events are neurological conditions and autoimmune diseases.

Adverse Events Associated with HPV Vaccines

Since the introduction of HPV vaccines 34,700 adverse events have been voluntarily reported to the US CDC, including 157 deaths and 6,977 permanent disabilities and chronic illness. This is possible because the Merck (vaccine manufacturer) funded Phase 3 clinical trials for Gardasil vaccine did not use an ‘inert’ (non-active) placebo in the unvaccinated control group. They used aluminium adjuvant in the comparison group and they did not collect long-term adverse events. The clinical trials only followed the health outcomes of all vaccinated girls actively for 15 days after vaccination. After this time the reporting of AE’s was voluntary which does not allow scientists to make causal relationships to the vaccine.

Here is a link to a video of the serious adverse events that some girls have experienced after using this vaccine. These have included seizures, paralysis, convulsions, tics, encephalopathy, chronic fatigue syndrome and death. The parents of injured children and those that have died after vaccination urge you to research this vaccine before you trust the government’s recommendation of this vaccine.

Report from the French Parliament on the Safety of Aluminium Adjuvant in HPV Vaccines (22 May 2014) 

The public hearing held in Paris on the safety of aluminium adjuvants in vaccines was attended by the French Health Minister and reported on by the European parliament. The hearing was open to the press and titled ‘Vaccine Adjuvants: A Controversial Question’. The most recent science on aluminium adjuvants in vaccines demonstrates that many individuals have a pre-disposition (genetic condition) to experiencing a serious reaction from aluminium adjuvants in vaccines. These serious reactions include neurological damage and autoimmune diseases – multiple sclerosis, arthritis, lupus, etc – and are caused by the artificial stimulation of the immune system with vaccines. Here is a link to the report on the public hearing http://sanevax.org/french-vaccine-debates-immediate-measures-required/

This indicates the significance of fully informing parents about the vaccines that are recommended in government vaccination programs and the importance of vaccines being administered by general practitioners with an assessment of the family history of the patient. Vaccines are a medical intervention and they should not be administered in school programs because family history is a contraindication to vaccination.

Conclusion

Cervical cancer is curable with early detection by Pap screening (9 out of 10 cancers) and all vaccinated women will still need Pap screening. This is because the vaccine (costing $Au450 per person) does not target ~30% of cervical cancer (13+ strains of high-risk HPV are not covered in the vaccine) – even if it is proven to be of some value in years to come. It is also a fact that HPV infections are harmless unless specific environmental co-factors are also present and this is why vaccinating all women in developed countries results in the majority of women (99%) being on a drug for a disease they are not at risk of getting.

Reference

Wilyman J, 2013, HPV vaccination programs have not been shown to be cost-effective in countries with comprehensive Pap screening and surgery. Infectious Agents and Cancer. 8:21 (June): pp1-8.

About the Author: Judy Wilyman MSc, is a PhD Candidate studying Population Health Policy at the University of Wollongong (UOW) School of Social Sciences, Wollongong, Australia. She is the founder of Vaccination Decisions, a website that she has set up to present her research.

Participate in Research

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. 

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.

What Else Can I Do To Help?

Hormones MatterTM 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. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow. For more information contact us at: info@hormonesmatter.com.

To support Hormones Matter and our research projects – Crowdfund Us.

Share

The Pharma Funded Promotion of HPV Vaccines

3893 views

Promotional campaigns for HPV vaccines have informed women that infections from HPV-16 and -18 are the cause of most cervical cancer. However, in 2006/7 when HPV vaccination programs were implemented globally, the scientific community knew that most women do not develop cervical cancer or warts after any type of HPV infection – including HPV-16/-18. HPV infections from all sub-types are found in high frequency among women with normal cervices and cervical cancer is a rare outcome from these infections. This demonstrates that HPV infection of any sub-type (including HPV-16 and -18) is not predictive of cancer; particularly as ninety percent of HPV infections have no clinical consequences at all. It has been known for decades that environmental and lifestyle co-factors are also necessary for HPV infections to progress to cervical cancer. This is why 83% of cervical cancer occurs in the developing countries.

Does the HPV Vaccine Prevent Cervical Cancer?

The promotional campaigns for HPV vaccines have been designed and funded by the pharmaceutical companies. This vaccine has not been demonstrated to prevent cervical cancer. It was trialled against a surrogate for cervical cancer – pre-cursor lesions (grade 2/3) in 15-26 year old women – and these lesions are not predictive of cancer later in life. More than 95% of high-grade lesions (CIN 3) in young women (15-26 years) regress without treatment. In addition, the phase 3 clinical trials that tested the vaccine against pre-cursor lesions were conducted from 2003 to 2007 and were not complete when the HPV vaccine was licensed by the US Food and Drug Administration in June 2006. The vaccine was fast tracked for approval by the FDA due to industry lobbying and Merck ensured that Gardasil® was not just approved for high-risk groups. The FDA approved the vaccine for universal use in all women even though it was known that many co-factors, that were not prevalent in developed countries (Australia, USA and UK), were essential for HPV infections to progress to cervical cancer. The time frame from application to approval of the HPV vaccine by the FDA was only 6 months and 3 weeks later the CDC recommended the vaccine for use in all women.

Yet the phase 3 clinical trials to determine the safety and efficacy of this vaccine against cervical cancer were not completed until 2007. In the US, the 1986 National Childhood Vaccine Injury Act removes liability from vaccine manufacturers for all design faults and negligence relating to their vaccines [1]. The US government has a no-fault compensation program that is tax-payer funded. This program removes all liability from the vaccine manufacturers and there is no onus to demonstrate that their products are safe and effective before they are implemented in the population. However, only Americans can seek compensation from the US government program. People who are harmed by HPV vaccines in other countries, such as Australia, receive no compensation from their governments.

Lobbying for HPV Vaccine Approval

Merck & Co is the manufacturer of the Gardasil® vaccine and when the medical director, Dr. Richard Haupt, was questioned about the speed with which the HPV vaccine was brought to the market he replied ‘Our hope and belief is that this is a remarkable vaccine that will have a huge impact on women [2]. ‘Hope’ and ‘belief’ are not the same as scientific evidence.

Politicians were lobbied and invited to receptions urging them to legislate against a ‘global killer’ [2]. Abramson, the chairman of the committee of the CDC that recommended the vaccine for all girls aged 11 or 12, stated ‘there was incredible pressure from industry and politics to approve this vaccine [2]. Diane Harper, a scientist involved in the development of the vaccine, agreed ‘Merck lobbied every opinion leader, women’s group, medical society, politicians and went directly to the people – it created a sense of panic that says you have to have this vaccine now [2]. In the US pharmaceutical companies are allowed to advertise directly to the public and the campaigns for HPV vaccines were very aggressive.

Educating Physicians about the HPV Vaccine

It was important for Merck to promote the vaccine through trusted sources and this was done by securing government reimbursement and mandates to promote the vaccine to all women, not just high-risk populations [3]. This enabled Merck to fund the professional medical associations (PMA’s) to promote the vaccine. The pharmaceutical companies supplied the medical associations with a Speaker Lecture Kit. This included ready-made presentations and letters to promote Gardasil® as a preventative for cervical cancer, even though the data was incomplete. The commercials for Gardasil® stated in small print ‘the duration of protection has not been established’ [2]. Much of the promotional material did not address the complexity of the issues surrounding the vaccine and did not provide balanced advice regarding the risks and benefits of the vaccine [3]. It was also presented in a way that obscured the involvement of pharmaceutical companies.

Doctors and nurses were recruited for an ‘Educate the Educators’ program created by the pharmaceutical companies to train health professionals to promote the vaccine. The PMA’s maintained a registry of educators and participants lectured to thousands of healthcare professionals. Hundreds of doctors were paid $4,500 per 50 minute lecture to present the information supplied by the pharmaceutical companies at Merck sponsored conferences [3]. They were also paid to attend advisory board meetings to discuss the vaccine [2]. In addition, there has also been an increase in cervical cancer awareness for patient groups financed with the help of Merck and GlaxosmithKline: often the financial support is indirect so patients are unaware that ‘expert’ advice has been paid for by the vaccine makers [2].

One of the Speaker Kit medical slides stated ‘Cervical cancer screening is described as secondary prevention identifying a precursor lesion; the HPV vaccine is primary prevention that would eliminate the cause of cervical cancer’ (Speaker Lecture Kit slide 13 in Rothman and Rothman 2009). This information is dishonest because it does not inform women that HPV alone is not sufficient to cause cervical cancer and also that there are 13+ other cancer causing strains of HPV that are not covered by the vaccine. Hence, the vaccine will not eliminate the cause of cervical cancer.

Whilst the slides acknowledged the uneven distribution of cervical cancer rates globally they did not draw attention to the risk factors that make cervical cancer a higher risk for women in developing countries. This knowledge is critical to women in determining the necessity for using this vaccine. The education campaigns emphasized the worldwide incidence of this disease whilst leaving out the risk factors for the disease and precautions about the risks of vaccines. Merck also funded the American College Health Association (ACHA) Vaccine Toolkit for clinicians [3]. This included talking points, sample e-mail messages to students and parents and sample press releases and public service announcements. At no time has the public been informed that the information they received on this vaccine was designed by pharmaceutical companies.

Protecting Population Health

The pharmaceutically funded promotional campaigns for HPV vaccines have maximized the threat of HPV infections and minimised the environmental and lifestyle co-factors that are necessary for the development of cervical cancer. The public places its trust in medical associations to provide non-biased science to health professionals for the promotion of medical products to the community. Clearly this trust has been breached in the case of HPV vaccines. At a minimum the public is entitled to be informed openly about relationships with industry and precise funding arrangements in order that they can weigh up the credibility of the information. This was an intentional deception as the pharmaceutical companies sought to present their information through trusted sources and the PMA’s condoned it.

Population health cannot be protected if there is no accountability for the health information that is supplied to doctors from industry funded research and presented to the community in the mainstream media.

About the author: Judy Wilyman MSc (Population Health), PhD Candidate University of Wollongong. More facts about HPV infections and the development of cervical cancer have been published in the Infectious Agents and Cancer Journal and can be accessed here:  HPV vaccination programs have not been shown to be cost-effective in countries with comprehensive Pap screening and surgery.

References

  1. Habakus LK and Holland M (Ed), 2011, Vaccine Epidemic: how corporate greed, biased science and coercive government threaten our human rights, our health and our children. Center for Personal Rights.
  2. Rosenthal E, 2008, The Evidence Gap: Drug Makers Push Leads to Cancer Rise, The New York Times, August 20, accessed 21.12.09
  3. Rothman SM and Rothman DJ, 2009, Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism, Journal of the American Medical Association, Vol 302, (7) p. 781 – 785.

Participate in HPV Vaccine Research

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.

Hormones MatterTM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

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

What Else Can I Do To Help?

Hormones MatterTM 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. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow. For more information contact us at: info@hormonesmatter.com.

To support Hormones Matter and our research projects – Crowdfund Us.

 

Share

Marketing the HPV Vaccines to Prevent Cervical Cancer

3449 views

HPV vaccines have been promoted to the public as a ‘vaccine to prevent cervical cancer’ (a non-infectious disease) yet these vaccines have never been demonstrated to prevent any cervical cancer. Six years after the HPV vaccine was implemented globally, Ian Frazer, the Australian inventor of the vaccine, stated ‘HPV vaccines may prevent cervical cancer.’ This is why the health department only refers to this vaccine as an ‘HPV vaccine’. In 2007 when the vaccine was approved for all women in many countries it was also known that there were 15 plus high-risk HPV strains that were associated with causing cervical cancer. Yet the HPV vaccine, Gardasil®, only covered 2 strains that were associated with cervical cancer – HPV 16 and 18 – the other 2 strains in the vaccine were associated with causing genital warts. This means there are 13 other high-risk HPV strains that are not covered in the Gardasil® vaccine and this is why vaccinated women will still require regular Pap screening.

Low Risk for Cancer

Women were also not informed that an infection with HPV is harmless and does not cause disease – cancer or warts – unless other co-factors are also present. These co-factors are not prevalent in developed countries. This is why Ian Frazer stated in 2005 ‘80-90% of cervical cancer occurs in the developing countries’. Not countries like Australia, Europe and the US. These countries have a low risk of cervical cancer. In Australia the death rate to cervical cancer when the vaccine was introduced in 2007 was 1.7 women /100,000. Pap screening combined with surgery is effective (9 out of 10 cancers) in detecting and preventing cervical cancer – and Pap screening will still be needed by vaccinated women. This means that it is not cost-effective for governments to be subsidizing the HPV vaccine when we already have an effective detection and prevention (surgery) in place that is virtually risk free.

HPV is Common

HPV is a common infection in all women. 80% of healthy women will have an HPV infection during their lifetime but this is harmless unless the co-factors are present that are necessary for the development of disease. In a developed country the risk of dying from cervical cancer is 0.25% but in developing countries it is 1.5%. Whilst the pharmaceutically funded marketing campaign informed women of the high incidence of HPV infection (80%) in women it did not inform women that the majority of these women are not at risk of developing cervical cancer or warts. The Australian Government states that the majority of women with an HPV infection are not at risk of cervical cancer.

This means that a drug has been recommended to all women but the majority of these women are not at risk of disease. However, many are now at risk from the side-effects of the vaccine. The government has not reduced the risk of disease with this policy but possibly increased the risk – at great expense. HPV vaccines are the most expensive vaccine on the market – $Au450 – yet the risks and benefits of this vaccine are still undetermined. The clinical trials had not been completed when the vaccine was approved for the market by the FDA in 2006. The safety of this vaccine has never been established.

The HPV vaccine had not been tested using an inert placebo in the unvaccinated group. The Merck funded clinical trial used aluminium adjuvant as the placebo in the unvaccinated group – this is a substance that is linked to causing autoimmune diseases and hypersensitivity. Comparing the vaccinated group to a group that is given aluminium adjuvant does not provide information on the harm this vaccine will cause in healthy people. The most frequent adverse reactions caused by this vaccine are neurological reactions such as seizures, convulsions, paralysis, tics, encephalopathy and thyroiditis. Many deaths have also been linked to the vaccine.

There were 21,265 adverse events reported to the US FDA and CDC alone up to September 2012. Many of these included permanent chronic illness and death. In 2013 the governments of India and Japan are no longer recommending this vaccine to the community.

This vaccine has only been trialled by the manufacturer of the vaccine, Merck, and it was promoted to the public by a campaign that was designed and funded by the manufacturer of the vaccine. In 2006 Merck won the ‘Brand of the Year’ for Gardasil® for creating a market out of thin air for this vaccine.

For the full report published in Infectious Agents and Cancer: HPV vaccination programs have not been shown to be cost-effective in countries with comprehensive Pap screening and surgery. Judy Wilyman’s research is being presented at the University of Wollongong, Faculty of Law, Humanities and the Arts, School of Social Sciences, Media and Communication.

Participate in Research

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.

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.

Share

A Day in the Life of Alexis Wolf: Six Years After Gardasil

7909 views

Alexis is now 20 years old. Six years have passed since her first injection of Gardasil. Life has changed drastically since then. After the Gardasil vaccine, Alexis developed encephalopathy, Traumatic Brain Injury (TBI) and a horrible seizure disorder that has yet to be controlled. Read the first part of Alexis’ Gardasil journey here.

Post Gardasil Brain Injury

Alexis’ brain injury post Gardasil is in the frontal lobe. This part of the brain controls so much of who we are. This has left Alexis with the mental capacity of about an 8 year old. She gets very confused easily and struggles with short term and long term memory so she requires constant supervision with frequent redirection on everyday tasks. Her skill level of preparing meals for herself and daily personal hygiene is almost nonexistent. She can no longer take showers due to the danger of having a seizure and falling. I have to help her take a bath and make sure she gets clean. I have to assist in washing her hair to make sure it gets clean. I also have to get her clothes ready for her. She can usually dress herself with little assistance.

Post Gardasil Bowel and Bladder Problems

Since receiving Gardasil, Alexis progressively lost bladder and bowel control.  She has to wear adult diapers.  Sometimes she will put her fingers inside her anus to try to help herself go #2. Although we have discussed this with all of her doctors and with her, telling her it is very dangerous for her and everyone one else, she cannot control herself. We make her wash her hands OFTEN. I wipe things down with Lysol wipes OFTEN.

Post Gardasil Pain

Alexis has often expressed frustration, depression and suicidal thoughts as to her present life and her future. She can be swift to anger and have great mood swings. She will slam doors, throw things, spit at us and call us a variety of cuss words. She is miserable most of the time. She complains about pain constantly. We have been turned away by three different pain specialist because they review her records and tell me she is “too complex” for them to treat. The only thing she has to help her with the pain is medical marijuana in the form of tinctures and vapors. When her head hurts really badly she will hit her forehead with the palm of her hand and say “brain get better, brain get better…” She also complains about all over body aches, sharp pains in her chest, joint and muscle pain. She will tell us that everything looks scary, strange and unusual even herself. The best description she was able to give us was that it looked like the walls were melting and people looked like cartoons. I had to take her out of high school for the above reasons. Her teachers were not very patient with her and they would push her buttons so one day she hit one of her teachers in the arm. The school called the police so I took her out of school.

Post Gardasil Seizures

Alexis’ speech patterns can often digress to repetitive statements over and over. This occurs without the knowledge that she is engaged in that behavior. Her motivation level is very low due to her brain injury. Getting her to do anything is quite the struggle. Almost every task is labored and takes lots of patience from the person helping her. Often at times she will flat out refuse to move and begs to take a nap. She naps off and on all day every day. We really do not know how long she sleeps at night but we think it is no longer than two hours at a time. The seizures happen all the time and they wake her up while she is sleeping. She is usually unable to fall back to sleep, so she wanders the house and searches for food. She has horrible impulse control and she is not able to tell if she is full or not. We have to keep the fridge and the pantry locked up at all times so she does not eat herself into a coma. If she eats a full meal and then has a seizure she will forget that she has just eaten and she begs for food saying that she is starving. We also lock up her medications because she will forget that she has taken them and try to take more even though I store them in those daily dose medicine boxes. She can have many, many seizures in a day. She takes anti-seizure meds and she also has a device implanted in her chest called a VNS therapy. It is supposed to reduce or stop her seizures but so far we have not really noticed a difference. She has had it for 3 years and soon she will be due for a battery replacement that will require another surgery. The battery should have lasted 5-10 years but the doctors have made so many adjustments on the therapy levels that the battery only has a few months left of power.

Alexis having a Seizure in 2010

Six Years and Counting

In the past six years we have had to deal with many people who do not understand the side-effects of the Gardasil vaccine. We have been accused of horrible things. We have had to endure being investigated by Child Protective Services, Adult Protective Services, police, detectives and more. Family, friends and neighbors have turned their heads and left us behind. Alexis’ father has not spoken to her in two years and all the help he had once offered is nonexistent. The government services that should support Alexis and her brain injury are bogged down so she is on a waiting list of over 40,000 people. I was told she MIGHT get services in 2019 when her name comes up next on the list. The way things have been going it is possible that all money and services may dry up and go away before her name even comes up.

Alexis’ inability to live independently will require lifelong care and assistance. I worry all the time about what will happen to her when I am no longer able to care for her. Every day new challenges arise so I can never put down my guard. I have been told by at least two doctors that I should look into some sort of institutional assisted living facility, but I cannot wrap my mind around that just yet. Life is quite different than it was six years ago, before Gardasil. Six years ago Alexis was a normal 14 year old. Starting to wear make-up and get interested in boys…working hard in school and enjoying honor roll. She had her whole life ahead of her and now she spends every day in a living hell filled with pain and misery, begging to be better, begging everyone to pray for her.

Six years ago, before Gardasil, life was very different.

Alexis Wolf before Gardasil
Alexis Wolf, age 14, before her first Gardasil injection.

 

Alexis Wolf after Gardasil
Alexis Wolf, age 20, six years after Gardasil.

 

Participate in Research

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.

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.

 

Share
1 2 3