vaccine ethics Archives - Hormones Matter

Do We Need a New Approach to Vaccine Recommendations?

Published on August 24, 2017

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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 17^th 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

Crawcroft et al. 2015. Do we need a new approach to making vaccine recommendations? BMJ; 30 January: 350; h308:1-6 (Analysis).
Crawcroft and Britto. 2002. Whooping cough – a continuing problem. BMJ; 325. 29 June : 1537-1538 (editorial).
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.
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.
Hutchins et al. 1988. Current epidemiology of pertussis in the United States. Tokai j Clin Med; 13(Suppl): 103-109.
Sencer et al. 1967. Epidemiologic basis for eradication of measles in 1967. Pub Health Reports; 82(3): 253-256.
Mulholland 1995. Measles and pertussis in developing countries with good vaccine coverage. Lancet; 345. Febr 4: 305-307.
McCloskey, 1950, The relation of prophylactic inoculations to the inset of poliomyelitis. Lancer. April 18: 659-663.
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.
Hedrich 1933. Monthly estimates of the child population “susceptible” to measles, 1900-1930, Baltimore, MD. Am J Hygiene: 613-635.
Isacson et al. 1993. How common is whooping cough in a non vaccinating country? Ped infec Dis J; 12(4): 284-288.
Olin 1995. Acellular pertussis vaccines – a question of efficacy. J of Hospital Infections; 30 (Suppl): 503-507.
Jenny Scott 1990. US slips in infant mortality. National Commission to prevent infant mortality.
Fine and Clarkson 1982. The recurrence of whooping cough: possible implications for assessment of vaccine efficacy. Lancet; March 20: 666-668.
Macfarlane 1982. Infant deaths after four weeks. Lancet; October 23: 9290939.
Preston 1994. Pertussis vaccination: neither panic nor complacency. Lancet; 344, August 20: 491-492.
Stott and Davis. 1981. Pertussis vaccination and pseudo-whooping cough. BMJ; 282,June 6: 1871.
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.
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.
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.

Are Safer Vaccines Possible?

by Chandler Marrs, PhD

Published on July 19, 2013

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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:

Industry pays for the research from bench through clinicals.
Industry pays fees to submit to FDA, which in turn fund the operations of the FDA –the agency tasked with reviewing the drug applications.
Industry funds the medical societies, medical journals, sponsors conferences and medical education. Negative research risks billions in funding for these organizations.
Expert and advisory panels that review safety claims are often linked to industry, paid by industry. What few conflict of interest guidelines existed were lifted by Congress in 2012.
Post approval surveillance is paid for by industry; studies are designed, reviewed and approved by industry sponsors, an example.
The data for all phases of research, from clinical trials through post approval surveillance are closed and unavailable for review by any agency, including the FDA and CDC. (There is push to open these up for all. See: YODA, European Medicines Agency, PLOS, and BMJ).
Only positive studies are submitted to FDA for approval. (Could have 99 negative, but only the one positive is used, here, here).
Only positive studies are published. (Both by inherent publication bias and for fear of losing industry funds).
A fair number of articles, published in medical journals, signed by experts are ghostwritten by industry, no more than mere marketing documents.
Once a vaccine is approved, the government via the CDC mandate and promotes vaccines and vaccination programs. A large part of the CDC mission is to promote vaccines.
Vaccine injury claims are registered with CDC and FDA sponsored organizations, VAERS and the National Vaccine Injury Compensation Program
Per the National Childhood Vaccine Injury Act of 1986, the government must pay vaccine injury claims through a .75 cent excise tax on the vaccines themselves.
Review of injury is done by the same agencies that approved and then promoted and mandated the vaccine.
Those same experts, supported by industry, that approved the vaccine, review the claims.
Findings of injury would open liability for remuneration from the same agencies that approved, promoted and mandated the vaccine – not to mention the loss of credibility.
Should a claim make it through these hurdles, legal recourse for injury is limited by favorable precedent.
Once service in government agencies is complete, it is often rewarded with lucrative roles within the same companies the agencies are responsible for regulating – within a year of leaving the government.
Industry spends billions annually on lobbyists, to keep these favorable regulations – 3 lobbyist per congressperson.

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.

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