vaccine

Piled Higher and Deeper: Vaccine Industry Shills

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A few years ago, I stumbled upon some philosophical papers on a concept called ‘vaccine denialism’ and for those same years, I have tried and failed to write a cogent and detailed response. Each and every time I re-read those papers, I become angered, incensed really, at both the obvious venality of these arguments, but also, the conspicuous hubris promulgated throughout. These articles possess a holier-than-thou approach to philosophical reasoning that I find contemptible, particularly when the arguments themselves, though tightly constructed, have no bearing on the reality they pretend to interpret. The authors presume that their intellectual eminence as philosophers and their ability to construct snazzy philosophical arguments grants them sufficient expertise to trust uncritically the affirmations and eminence of others in fields disparate from their own. It is as if once one reaches a level of expertise in one’s field, he/she is somehow magically, and without so much as a modicum of effort, granted expertise in all other fields; a sort of universally transferable expertise. If it were a gender issue, I would call it mansplaining, but it is not. Authors of both sexes participate in these shenanigans. They evoke the pretense of knowledge and nothing more.

“It is an approach which has come to be described as the ‘scientistic’ attitude – an attitude which, as I defined it some thirty years ago, ‘is decidedly unscientific in the true sense of the word, since it involves a mechanical and uncritical application of habits of thought to fields different from those in which they have been formed’.” – Friedrich von Hayek

With the confidence of transferable expertise, the authors who proffer the tenets of vaccine denialism proceed, mechanically and uncritically. Each paper begins with the presumption that the research on vaccines is settled and that vaccines are entirely safe and effective, and thus, necessary. No exploration of the actual research, the science, or even the business models or ethics of the manufacturers of these products is undertaken. It is simply presumed that the science of vaccines is unassailable, beyond question, and beyond repute. Not only is this not the case, but there is an entire literature that painstakingly details the egregious errors in vaccine science and the industry and regulatory corruption that allows such errors to promulgate.

Armed with an uncritical acceptance of a heavily conflicted science and possessing a certainty that no legitimate scientist would claim, these authors proceed to denigrate the legitimacy of any counterview. From this position of absolute certainty, the authors suggest that we must seek to understand why the denialists deny/refuse vaccines. The underlying assumption is that since these products are safe and effective, any reasonable person would gladly submit to their protective powers (and they, by their own estimation, are the arbiters of reason). To not accept the totality of the benefits of these products ipso facto declares one’s inherent foolishness; a foolishness that can only be explained by an alternate reality of sorts. In philosophical terms, the rules by which reality is constructed is called an ‘episteme‘.

In this work, all sorts of constructs are used to understand the alternative ‘episteme‘ of the denialist, including notions of displaced power struggles between the sexes – male physicians / female caregivers, moral permissiveness, intellectual incompetence, and, my favorite, a sort of neurotic tribalism. Most of these articles are published in reputable public policy and philosophy journals. Indeed, vaccine denialism, also called vaccine hesitancy, is such a hot topic in these journals that I cannot help but wonder about industry connections. Even the World Health Organization has jumped aboard the vaccine denialism train, promoting ways to combat the purported egregious lack of reason.

Potential industry influence aside, so much is wrong with these articles that reading them is painful – head bangingly painful. The entire body of work, from the derogatory and inflammatory titles that serve to shut down any discussion about risks, to the use of old misogynist tropes of power and conscripted morality through the selective abrogation of philosophical constructs, represents all that is wrong with the current model of pharmaceutical medicine and those who seek to justify it (neither does it speak too highly of academic philosophy). These articles are myopic, uncritical, and downright ignorant of the science and the institutional corruption of the organizations promoting said science.

What strikes me as the most egregious error in this line of reasoning is the total lack of critical evaluation of the veracity of the original premise. The writers unconditionally accept that vaccines are completely safe and effective as reported by the CDC and other agencies. They also accept wholeheartedly the concepts of herd immunity and embrace the notion that collateral damage, and side effects, are acceptable so long as the greater good is achieved.

The premise of total safety and efficacy is incorrect and I would say more than just a little bit ignorant. By not questioning those presumptions and taking the safety and efficacy claims of an entirely corrupt industry as ‘truth’, all of the arguments crumble. Heck, even if it were not a corrupt industry, it is an obvious fallacy to assume anything in medical practice is entirely safe and effective for all people; a fallacy that does not require a PhD or MD to recognize. Simple common sense tells us that injecting toxic compounds into the body is likely to have some deleterious effects on health. An exploration of the chemical makeup of these compounds and even the manufacturer’s own warnings shows this to be true.

The efficacy question is no less problematic, particularly when one becomes versant in the larger body of vaccine research. If, as some of the ‘philosophers’ suggest, it is our moral duty to vaccinate for the good of the community and to bear any ill-effects that these chemicals impart, the reasonable person should like to be certain of the benefits, but we cannot.

“…what most politicians, who believe they are acting in the best interest of their constituents don’t understand, and likewise most physicians who are on the payroll of vaccine manufacturers either directly or by proxy choose to ignore, is that a substantial number of the recommended vaccines cannot prevent transmission of disease. This is because either they are not designed to prevent the transmission of infection (they are intended to prevent disease symptoms), or because they are for non-communicable diseases.”

If, as the research shows, no vaccine is completely safe and many vaccines do not promote public good in a way that makes compulsory vaccination reasonable, then what are we to make of these philosophical contortions that demonize folks who dare to present legitimate concerns? Is simple ignorance at play or is a more willful, perhaps even purchased, ignorance responsible? For as much as these folks fail to recognize the legitimacy of the vaccine concerns or even the reality of the adverse reactions that fuel these concerns, it is difficult not to reflect back at them the alternate episteme hypothesis. One could argue that the episteme under which most of this uncritical acceptance of chemical safety resides, is one that was carefully constructed by those who benefit most from this dogmatic approach.

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This article was first published on January 30, 2019.

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episteme

A Matter of Episteme

Last week I wrote about a series of articles claiming that folks who question vaccine safety and efficacy have constructed

Do We Need a New Approach to Vaccine Recommendations?

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vaccination

In a recent article published in the British Medical Journal, Crowcroft et al (2015) suggest we need a new approach to vaccine recommendations. Focusing mainly on the economic and ethical considerations involved in public policy surrounding vaccine programs and vaccine approval the authors write:

“We are on a steep trajectory away from an era of inexpensive vaccines for diseases that are widespread in the absence of immunisation… Technologies such as searching genetic codes for possible antigens and the development of new adjuvants to stimulate immune responses also bring considerable uncertainty about safety and effectiveness.” 

“…some sections of society are less likely to vaccinate themselves or their children. Those who hesitate to vaccinate are often highly educated, well resourced, and demand respect for their perspectives.” 

Though speaking specifically about a ‘novel vaccine’ for serogroup B meningococcal disease, Bexsero (Novartis, Basel), the issues and problems of vaccine safety and approval apply to all vaccines. Arguably, more important than the economic risk to benefit models used by healthcare policy analysts to calculate the health costs for vaccines are the very real questions associated with safety and efficacy. Those concerns neither make it to same cost/benefit calculations, inasmuch as the actual costs associated with mitigating adverse reactions are not included, nor do they appear paramount to policy makers or ethicists. The preference instead is to assume that risks of adverse reactions and ineffective vaccines are minimal compared the risks associated with the diseases vaccines purport to protect against. I would suggest that efficacy and safety are central to any risk/benefit calculation and ensuing policy decision. For without those data, neither the economic costs nor the human costs of said policy decision can be accurately assessed.

Vaccine Safety and Efficacy  

If we look at the historical data, across multiple vaccines, a pattern emerges that is quite distinct from the models proposed by many healthcare agencies and governmental institutions.

Crawcroft and Britto (2002) called whooping cough a continuing problem, which has re-merged in countries with high vaccination coverage [with inexpensive vaccines] and low mortality.  Then they contradicted themselves. “Pertussis has re-emerged…because of low coverage after a vaccine scare in the 1980s (in the United Kingdom) or the use of vaccines with poor efficacy (Canada, Sweden).”

“Germany stopped their vaccination programmes completely and only reinstated vaccination for pertussis after years of recurrent epidemics of whooping cough.” However, according to Miller and Farrington (1988), “In West Germany, unlike the UK, there are no national statistics on pertussis incidence, no national vaccination policy and no figures for vaccine uptake. Local studies have shown that vaccination rates are low and that pertussis is prevalent particularly in 2-4 year age-group, which is typical of a country with low uptake, similarly serotype 2 predominates.”

Whooping cough vaccine was introduced in the UK during the 1960s and national statistics on uptake rates are available from 1961.

“Mortality data show that death from whooping cough declined before ‘the disease was reduced by vaccination’”.

Are there any Diseases Reduced by Vaccination? 

Starting with smallpox vaccines, continuing through typhoid, diphtheria and later on DPT and other vaccines, the highest incidence of targeted diseases occurred in the vaccinated. Famously, the Leicester citizens’ boycott of smallpox vaccine stopped smallpox epidemics in their city. Outbreaks of typhoid in the army occurred right after mass vaccination (Wright 1901). A huge diphtheria outbreak in the vaccinated in the 1940s in Nazi Germany and in the Nazi occupied countries. A documented 300% increase in the incidence of whooping cough starting in the 2-months old DPT recipients in the USA in mid seventies (Hutchins et al 1988).

The US outbreaks of measles in even 100% vaccinated populations started in 1963 with the licensure and mass use (Sencer et al. 1967) of the  measles vaccines. The destruction of transplacentally-transmitted immunity (Mulholland 1995) predicted by vaccine researchers early in the piece, resulted in pertussis and measles occurring in newborn babies in all countries with high vaccination compliance. Outbreaks of provocation paralysis (infantile paralysis) provoked by all vaccinations) (McCloskey 1950) are well-documented.

Natural infectious diseases of childhood (both mortality and morbidity) were on the downward trajectory 50 years before any vaccines were administered in mass proportions. The main reasons were better nutrition (especially better vitamin C status), sanitation, clean water and uncrowded living conditions. Generational immunity acquired by repeated exposure and inherited and acquired natural immunity cannot be overlooked, either.

The largely unvaccinated Amish (claiming religious exemption) had not reported a single case of measles between 1970 and December 1987, for 18 years (Sutter et all 1991), while the well-vaccinated non-Amish communities experienced regular 2-3 year epidemics in even 100% vaccinated populations. Pro-vaccinators claimed success and set a date for measles eradication (1 October 1982). Instead, large measles outbreaks occurred in the vaccinated non-Amish, starting in 1982, and on 5 December 1987 in the Amish.  The situation simply confirmed Hedrich’s (1933) evaluation of measles epidemic cycles (2-3, 11, and even 18 years).

Pertussis followed similar dynamics motivating pro-vaccinators to claim success with early pertussis vaccination. However, it did not take long and pertussis outbreaks in fully vaccinated populations followed mass vaccination drives. Instead of abandoning the obviously ineffective vaccination, the culture of “lies, damn lies and statistics” set in.

Sweden discontinued pertussis vaccine use for 11 years in 1979; whooping cough became a mild disease and stopped occurring in babies and young children below one year of age (Isacson et al. 1993).  Very few doses of pertussis vaccine were administered, however, even those few recipients developed pertussis (one in 3).  372 (61%) of the 377 parents interviewed, reported clinical pertussis in their unvaccinated children (confirming Hedrich’s (1933) concept of herd immunity).

When Sweden resumed pertussis vaccination (with acellular vaccine) in mid 1990s, not only the incidence went up, but the babies under the age of one contracted the disease already during the trials of acellular vaccine straight after the first dose of the vaccine (Olin 1995). The trial was discontinued before the expected termination date. Epidemics in the vaccinated have continued.

Japan moved the DPT & P vaccination age to two years in mid seventies with similar effect as observed in Sweden, including a substantial fall in the overall infant mortality (from 17th to the first, lowest infant mortality rate in the world (Jenny Scott 1990).

The UK experienced similar dynamics, also in mid seventies. After the first media report of brain damage linked to DPT vaccine the UK parent’s compliance fell down to 30% or even 10%), but according to Fine and Clarkson (1982), paradoxically, the inter-epidemic period did not decrease after the 1974 fall in vaccine uptake.

Pertussis incidence and hospital admissions fell markedly and so did the overall infant mortality. Macfarlane (1982) wrote, ”The postneonatal mortality fell markedly in 1976, a year on which a sharp decline in neonatal mortality rate began. Between 1976 and 1979, however, neither the late neonatal nor the post-neonatal mortality rates fell any further.  Indeed, the post-neonatal mortality rate increased slightly among babies born in 1977.  Obviously, when the compliance started climbing, so did the infant mortality rates in England and Wales and Glasgow. Epidemics in the vaccinated followed.

Preston (1994) analyzed the pertussis situation and wrote, ”In the mid-1970s, the general public and many health care professionals in Britain lost faith in the safety of whole-cell pertussis vaccine. This reaction (largely in response to fears about vaccine-induced brain damage) was unjustified, and caused vaccine uptake in infants to plunge from 80% to 30%.” Preston compared this with the situation in Massachusetts and wrote, “An apparent increase in incidence in 1989-91 was largely due to wider surveillance and the introduction of serologic diagnosis for adolescents with not less than 1 week of paroxysmal coughing…” “Stott and Davis suggested that, in the absence of a positive culture, the term “pseudo-whooping cough” is appropriate for paroxysmal cough of less than 3 weeks duration. Although the authors of the Massachusetts report express concern about the diagnosis of pertussis in fully vaccinated children, they do not tell us how many of these children had positive cultures, culture positivity being the only reliable laboratory test.

Cincinnati likewise experienced a resurgence of pertussis in 1993, with 223 culture-positive cases.  Although 82% of diagnosed “cases” between 6 months and 6 years of age had received at least three doses of (Connaught and Lederle) vaccine, the criteria for clinical diagnosis are not stated, nor are we told the number of culture-positive cases in this age group…Both consider panic measures, such as neonatal vaccination, immunisation of pregnant women and boosting with acellular vaccine.” And, we are told “The vaccine cannot be expected to protect against pseudo whooping cough.  Nevertheless, there are several good reasons for genuine failure of pertussis vaccination.”

Early Vaccination and Later Disease

In all countries with national vaccination programs, the distribution of all vaccine-preventable disease experienced deranged age distribution. The present situation is that in all developed countries with high vaccination compliance epidemics of pertussis, measles, mumps, etc. occur with increased frequency and magnitude, and, in the vaccinated.

Medical researchers documented waning vaccine ‘immunity’, changes in the serogroup, polymorphism and mutations of the causative organisms (directly linked to vaccines in a similar fashion as experienced with antibiotics and other antibacterials and antivirals) (Cassiday et al. 2000; Octavia et al. 2011; Mooi et al. 2014).

Medical research provides important scientific evidence against continued use of vaccines, which is an outdated, ineffective and unsafe technology. Moreover, the evidence of the benefits of natural infectious diseases in providing a life-long specific and non-specific immunity has also been mounting.

References

  1. Crawcroft et al. 2015. Do we need a new approach to making vaccine recommendations? BMJ; 30 January: 350; h308:1-6 (Analysis).
  2. Crawcroft and Britto. 2002. Whooping cough – a continuing problem.  BMJ; 325. 29 June : 1537-1538 (editorial).
  3. Miller and Farrington. 1988.  The current epidemiology of pertussis in the developed world: UK and West Germany. Tokai J Exp Clin Med; 13 Suppl): 97-101.
  4. Wright 1901.  On the changes affected by anti-typhoid inoculation in the bactericidal power of the blood; with remarks on the probable significance of these changes.  Lancet; Sep 14: 715-723.
  5. Hutchins et al. 1988. Current epidemiology of pertussis in the United States.  Tokai j Clin Med; 13(Suppl): 103-109.
  6. Sencer et al. 1967.  Epidemiologic basis for eradication of measles in 1967.  Pub Health Reports; 82(3): 253-256.
  7. Mulholland 1995.  Measles and pertussis in developing countries with good vaccine coverage.  Lancet; 345. Febr 4: 305-307.
  8. McCloskey,  1950,  The relation of prophylactic inoculations to the inset of poliomyelitis. Lancer. April 18: 659-663.
  9. Sutter et al. 1991.  Measles among the Amish: a comparative study of measles severity in primary and secondary cases in households.  J Infect Dis; 163: 12-16.
  10. Hedrich 1933.  Monthly estimates of the child population “susceptible” to measles, 1900-1930, Baltimore, MD.  Am J Hygiene: 613-635.
  11. Isacson et al.  1993.  How common is whooping cough in a non vaccinating country?  Ped infec Dis J; 12(4): 284-288.
  12. Olin 1995.  Acellular pertussis vaccines – a question of efficacy. J of Hospital Infections; 30 (Suppl): 503-507.
  13. Jenny Scott  1990.  US slips in infant mortality.  National Commission to prevent infant mortality.
  14. Fine and Clarkson 1982.  The recurrence of whooping cough: possible implications for assessment of vaccine efficacy.  Lancet; March 20: 666-668.
  15. Macfarlane 1982.  Infant deaths after four weeks.  Lancet; October 23: 9290939.
  16. Preston 1994.  Pertussis vaccination: neither panic nor complacency.  Lancet; 344, August 20: 491-492.
  17. Stott and Davis.  1981.  Pertussis vaccination and pseudo-whooping cough.  BMJ; 282,June 6: 1871.
  18. Cassiday et al. 2000.  Polymorphism in Bordetella pertussis pertactin and pertussus toxin virulence factors in the United States, 1935-1999).  J Infect Dis; 182: 1402-1408.
  19. Octavia et al. 2011.  Insight into evolution of Bordetella pertussis from comparative genomic analyses: evidence of vaccine-driven selection.  Mol Biol Evol; Jan 10; 28(1): 707-715.
  20. Mooi et al. 2014.  Pertussis resurgence: waning immunity and pathogen adaptation – two side of the same coin.  Epidemiol Infect. Feb 13; 142(4): 685-694.

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This article was published originally on Hormones Matter on March 19, 2015.

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Vaccination as stressor

Vaccination as a Stressor

An article in Time magazine, dated June 24, 2019, was published under the heading of “Vaccine Wars”. As most people

Are Safer Vaccines Possible?

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Vaccine safety

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.

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. 

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Gardasil Research versus Marketing: The Reality of One Less

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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.

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Is Gardasil Mandated in Your State?

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Last week I reported on the controversy of the Gardasil Vaccine produced by Merck (it is important to note that GlaxoSmithKline also makes an HPV vaccine called Cervarix). Many women left comments which confirmed my statements and research with personal stories of their once healthy daughters who are now sick and disabled from this vaccine. This week I will look at which states are mandating that school children get the vaccine and one state that passed legislation for the vaccine to be given to children as young as 12 years old without parental consent.

As I stated in my op-ed piece on the Affordable Health Care Act, I am a libertarian. One of my main concerns about the government controlling our health care is mandated vaccines. To those who think that this could never happen, the simple fact is it’s already happening in our schools and in our military. While I’m a proud Marine, I’m ashamed of the fact that the government has been known to conduct ethically questionable experiments on our troops. In my opinion, vaccines are one of those experiments and rather than do they protect the patient, they ask will the people blindly take them?

While in the Marine Corps, I was vaccinated against every possible disease that there is a vaccine for not once, but twice, sometimes even three times (somehow my shot records never made it to my medical records, which I understand is common in the service). This includes the HPV vaccine, Gardasil. When I say it was mandated, I do in fact mean that I was forced to get these vaccines. Per the Uniform Code of Military Justice (UCMJ) my body was property of the US Government when I was in the service. You probably think I’m kidding; I’m not. During safety briefs before summer holiday weekends we were told to wear sunscreen (check out the dangers of sunscreen here) because if we got a sunburn while off-duty we could be charged with destruction to government property. Now, that was a little extreme and I don’t know anyone who was actually charged over a sunburn (although it wouldn’t surprise me), it was still true – we were government property. I tried to avoid the Smallpox vaccine and successfully did until we were at the airport terminal boarding the plane for Iraq, I was informed by our unit’s corpsman administering it, “If you don’t get this shot you can’t deploy.”

I sarcastically replied, “Okay,” only to turn around and see the Executive Officer (XO) standing behind me.

Not amused by my sarcasm, he said, “If you don’t get the shot I will charge you with disobeying orders Lieutenant.” He was dead serious.

Thankfully, I have not had any major complications (although the more research that I do, I think I have some ongoing side effects from the Gardasil vaccine).

State Mandates

According to the National Conference of State Legislatures (NCSL) school vaccine requirements are determined by individual states, a right which might be revoked now that states are mandated to enforce individuals to purchase insurance per the Federal government.

In 2006, the Michigan Senate was the first to introduce legislation (S.B.1416) requiring girls entering sixth grade to have the vaccine. The bill was not enacted. According to NCSL, “Since 2006, legislators in at least 41 states and D.C. have introduced legislation to require the vaccine, fund or educate the public about the HPV Vaccine and at least 21 states have enacted legislation, including Colorado, Indiana, Iowa, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Nevada, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Dakota, Texas, Utah, Virginia and Washington.”

In February 2007, Texas Governor bypassed state legislation and made an executive order that all females going into the sixth grade had to get vaccinated with Gardasil. In May 2007, state legislators introduced and passed the bill H.B. 1098 to override the executive order. 

The Virginia legislature also passed a school vaccine requirement for Gardasil in 2007. To see what legislation related to the HPV vaccines and information has been introduced to your state, see NCSL’s chart here.

No Parental Consent Necessary

Can it get worse than mandating parents to give their kids a vaccine that causes severe side effects and does nothing more than an annual pap can do to prevent cervical cancer? Of course it can. On January 1, 2012, California’s Governor Jerry Brown signed the bill AB 499 into law. It states:

“Existing law authorizes a minor who is 12 years of age or older to consent to medical care related to the diagnosis or treatment of an infectious, contagious, or communicable disease if it is related to a sexually transmitted disease. This bill would additionally authorize a minor who is 12 years of age or older to consent to medical care related to the prevention of a sexually transmitted disease.  Time-critical preventive services for sexually transmitted diseases include the hepatitis B vaccine, post-exposure prophylactic (PEP) HIV medication (which must be administered within 72 hours of exposure), and the human papillomavirus (HPV) vaccine, which, if given prior to exposure, may significantly reduce the risk of certain cancers.”

How did we get here?

This is the easy part. Look at who is benefiting the most -follow the money. In this case, the makers of the vaccines are obviously going to benefit if their product is mandated by use of all children the age of 12-26 years old. Similar to when 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.

The cost of one shot is $120 and the vaccine is a series of three given over the course of a year. That’s $360 for every girl and boy who gets the vaccine. In most states insurance is mandated to cover this vaccine and there are numerous state and federal programs for those who do not have insurance. With all the side effects and even deaths from this shot, why wouldn’t politicians put those tax dollars to use providing un/under-insured women access to pap smears, a screening test that can catch HPV before it develops into cancer far enough in advance that fairly simple steps can be taken to stop cancer before it even develops? Why, because Merck and GlaxoKlineSmith can’t profit from preventing cancer that way. And how much has Merck made from the Gardasil vaccine? According to CNN Money, Gardasil grossed over $1.1 billion in the first nine months on the market. Unfortunately for Merck, the initial sales momentum has flattened out and is declining. The American public are obviously not buying this vaccine, so Merck and others are going to legislators and to have it mandated instead.

What can you do?

As I always say, GET INVOLVED. Get educated. Complacency, apathy and ignorance are how we got to this point (and Citizens United).  Be wary of a bill that puts a private company’s profits above the safety and well-being of the individual, especially one that involves the health of your child. It is incumbent upon all of us to assess the safety and risks of any medication or vaccine before taking it.

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. 

Further Reading:
Gardasil: Miracle or Deadly Vaccine?
What about the Pap?

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Gardasil: Miracle or Deadly Vaccine?

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I normally don’t speak for a larger population because we are all unique individuals; however, I think in this case I can speak for all women. Dread is the only emotion that is drudged up when you get the friendly reminder card in the mail that it’s time for your annual appointment. Stripping down and wearing a stiff hospital gown with your feet up in cold metal stirrups while a doctor sticks a cold, duck-lip looking contraption up your nether regions for a Papanicolaou (pap) test. I don’t think there is a single woman on earth who enjoys this necessary torture, but it is the primary way to detect diseases and/or conditions including cervical cancer.

That is until 2008, when Merck released a vaccine that is advertised to protect against the strands of the Human Papillomavirus (HPV) that cause cervical cancer and genital warts. The shot is being administered to young girls and boys (who can carry the disease, but do not suffer from any health conditions because of it). The shot is administered to girls ages 11-26 years-old and boys age 9-26 years old, but do the pros outweigh the cons? I’ve heard of doctors tell parents, I wouldn’t give this shot to my own child, how can I recommend it to my patients. And I’ve heard doctors say, it’s the greatest vaccine we have that actually protects against cancer.

Let’s look at whether or not prevention outweighs the serious side effects and risks.

HPV

Carolyn Vachani, RN, MSN, AOCN writes that, “The Human Papilloma Virus (HPV) is one of the most common sexually transmitted infections (STI) in the world. It is estimated that 5.5 million people worldwide are infected annually. Sexually active individuals have an 80 to 85% chance of being infected at some time in their life.” It’s not just a sexually transmitted infection; the virus invades the epithelial cells (type of skin cell) on other parts of the body including the oral mucosa, esophagus, larynx, trachea, and conjunctiva of the eye. Further more Vachani writes, “Researchers have identified 100 different strains of HPV, 40 of which can infect the anal and genital areas.”

On Merck’s Gardasil website it boasts, “GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV.” So, what about the other 96 strands, 36 of which infect the anal and genital areas?

Like HIV, there is no cure for HPV; but unlike HIV, the body can fight HPV and win 80% of the time. For the 20% whose body cannot fight off HPV there is a risk that cervical cancer can develop. If it is a strand that causes genital warts there are various methods to treat and get rid of the warts until the body is able to fight off the infection on its own.

Cervical Cancer

In spite of the high odds the body can fight off an HPV infection, cervical cancer is the second most common cancer in women worldwide. Forty years ago, cervical cancer was the leading cause of death of women in the US, but thanks to the availability of the pap test that has decreased 75% over the past 50 years. With annual pap tests, precancerous cells can be detected and removed from the cervix rather simply. According to the CDC, in 2008:

  • 12,410      women in the United States were diagnosed with cervical cancer.
  • 4,008      women in the United States died from cervical cancer.

Those numbers are low compared to developing countries. Out of the approximately 500,000 new cases of cervical cancer annually, 83% are in developing countries. The annual death rate of cervical cancer worldwide is approximately 273,000, of which developing countries account for 75% of the deaths.

There are no symptoms of cervical cancer and no way to detect it except a pap test, which isn’t available in most developing countries explaining the higher mortality rates. A vaccine that protects against the most common strands of the virus is better than nothing, right? Well, let’s take a closer look and see what the controversy is all about.

Gardasil

FDA approved Gardasil on June 8, 2006. As Chandler Marrs reported in Why Few Women Trust the FDA, the FDA doesn’t always have the best record in women’s health, making it difficult to believe everything they pass is safe or effective. The vaccine is a series of three shots taken over the course of a year. On the FDA website it states, “Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations.”

How many deaths and serious side effects are acceptable for the FDA? Apparently quite few; Natural Society reports, “Between May 2009 and September 2010 alone, Gardasil was linked to 3,589 harmful reactions and 16 deaths. Of the 3,589 adverse reactions, many were debilitating. Permanent disability was the result of 213 cases; 25 resulted in the diagnosis of Guillain-Barre Syndrome; and there were 789 other “serious” reports according to FDA documents.”

What does the FDA have to say? “Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS [Vaccine Adverse Event Reporting System]. There was not a common pattern to the deaths that would suggest they were caused by the vaccine.”

On the website Classaction.org, where you can get legal advice on class action law suits against the makers of Gardasil if you or your child has suffered from side effects, they state, “As of Feb. 14, 2011, the CDC has reported that there have been 51 reports of deaths among females who received the HPV vaccine. A total of 32 of these death reports have been confirmed, meaning that a doctor has reviewed the report and any associated records. There have been two reports of deaths among males who were injected with Gardasil.”

That is just in America where cervical cancer can be detected early with annual pap tests. The vaccine against HPV is given worldwide to girls and boys to prevent spreading of HPV. It is now marketed as prevention against anal cancer even though only 10% of women with HPV will develop cancer and  cancer associated with HPV is only responsible for 1% of all cancer deaths.

Judicial Watch

In 2011, Judicial Watch, a conservative, non-partisan educational foundation that promotes transparency, accountability and integrity in government, politics and the law stepped in. They reported that they, “received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reaction reports detail 26 new deaths reported between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome. The documents come from the FDA’s Vaccine Adverse Event Reporting System (VAERS).”

The report also states, “Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse. Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment.” The vaccine is suggested for women who test positive for HPV in order to prevent them from contracting the other strands. (The 25 page report can be viewed here.)

Conclusion

Merck’s website advertises “You/your son or daughter could be one less person affected by HPV disease.” It is important to research all the possible side effects and the rate of occurrence, as well as your/your daughter’s ability to have annual pap tests before making this decision. We are all exposed to numerous strands of the HPV virus. Of the 100 strands, 40 are contacted through sex or genital skin contact. Of those 40, Gardasil only protects against the 4 most common strands because adding more strands to the vaccine caused even more severe side effects. In 80% of the cases of genital HPV, the body fights off the infection. With pap tests, doctors can detect cervical cancer before it becomes deadly (as long as women are getting them done annually). As much as we all hate that annual appointment, it may be a better solution to stick our legs in the stirrups for an exam rather than risk the side effects of the Gardasil vaccine. You decide.

Next week, I will look at how Gardasil was approved by the FDA, how states are mandating it for school children, and how states are passing legislation to make it legal for health professionals to administer the shot to minors without parental consent.

Additional Resources

IARC Monographs on Human Papillomavirus Virus and Studies of Cancer in Humans

Is Gardasil mandated in your state? Read more here
How does a Pap Smear Test prevent cervical cancer? Read more here.

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. 

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