Marc Girard M.D., M.Sc. on the science of vaccination

 

 

(please note this page has been updated on 2nd August 2017 due to incorrect information)

Marc Girard, MSc, MD – Biography
After a first training leading to a MSc in mathematics (partial differential equations), Marc Girard became a MD in parallel of his research on mathematical modelling. He works on drugs mainly as a consultant for pharmaceutical firms, and also practices as a psychotherapist of Freudian obedience.
Besides a number of scientific papers (about 90, most of them in peer-reviewed journals), he published also in literary criticism, esp. about Flaubert, Balzac, Zola as well as the Grimm’s tales. His experience as a drug specialist goes from the early phases of development (I, II and III) to late post-marketing, with a long standing interest in safety (monitoring of clinical trials, pharmacovigilance, pharmacoepidemiology): as early as in 1984, he was the first French author to publish a criticism on the methods used to assess the causality of drugs adverse reactions. He also has a long practice of co-operation with regulatory departments as well as marketing teams, including the redaction of a number of expert reports and medical writing (papers, brochures, proceedings). He was also a medical expert witness and has been commissioned by French Judges in a number of judicial litigations involving drugs (growth hormone, appetite suppressants, cerivastatine, vaccines…); in France, his papers published in judicial journals (about drug causality, defective products and medical expertise) have been appreciated by a number of lawyers and magistrates, and he is currently in charge of a seminar on drugs and medical expertise in two Faculties of law (Versailles & Chambéry). He is also regularly invited to comment on the ethics of drug development.

 

 Here are some of his comments and papers regarding vaccines.

extract from Editorial – Being or not being an “activist”, that is the question

In effect, if this is so easy for amateurs to get involved in vaccine controversies, this is because as a whole, the development, assessment and administration of these agents is a shame for the medical world: the weaknesses, contradictions, dissimulations and even lies of most vaccine leaders or governmental “experts” are so gross that they cannot escape the attention even of non medically-trained persons.

 

 

Marc Girard’s comment on “Safety of vaccines used for routine immunization of U.S. children: a systematic review.”

“By the distance between what it demonstrates and what it claims, this paper (as well as the preceding IOM report this one is supposed to update) illustrates that the issue of vaccines safety is still a matter of serious concern for anyone endowed with a minimum of expertise in drug safety or pharmacoepidemiology.”

 

On VAERS safety data-

“Another illustration of the same bias: when reassuring, VAERS data are unchallenged, whereas the shortcomings of the system are immediately pointed out each time they may suggest a safety problem…”

On Iatrogenic risk

“Yet, experience of drug assessment suggests that below frequencies of, at best, 1-2% of exposed patients, clinical trials fail to identify drug side-effects with a minimum of reliability (the statistical power of postmarketing surveillance being even lower by far). In a country like the USA, this detection threshold is consistent with a shadow area on iatrogenic risk of about 40,000-80,000 persons per vaccine for each vaccinated class of age: it should be obvious that risk-taking of such a size is simply disproportionate to the potential benefits of reducing the morbidity of trivial diseases (even taking into account the natural tendency of vaccine promoters to exaggerate the efficacy of immunizations…). The stubborn obfuscation of this evident arithmetical imbalance by health professionals or governmental agencies suggests that there is something rotten in the kingdom of immunization…”

Safety of vaccines used for routine immunization of U.S. children: a systematic review.

Maglione MA. Pediatrics. 2014. (bottom of page)

Summary of points raised –

Methodological consistency and biases questioned.

Immunization against trivial diseases.

Conflict of interests

Methodological defects concerned with safety assessments in general

Underreporting of adverse events

VAERS data

Clinical trials and post marketing surveillance unreliable.

Iatrogenic risk of immunizations

 

2005 Letter to Dr Jong-wook Lee Director General – World Health Organization

Auto-immune risks of hepatitis B vaccination: a clue to biological plausibility

On Hep B-

It is blatant that in the promotion of the hepatitis B vaccination, the WHO has never been more than a screen for an undue commercial promotion, in particular via the Viral Hepatitis Prevention Board (VHPB), created, sponsored and infiltrated by the manufacturers (Scrip no. 2288, p. 22). In Sept 1998, while the dreadful hazards of the campaign had been given media coverage in France, the VHPB met an panel of “experts”, the reassuring conclusions of which were extensively announced as reflecting the WHO’s position: yet some of the participants in this panel had no more “expertise” than that of being employees of the manufacturers, and the vested interests of the rest did not receive any attention.

 

 

On Adverse events following vaccination-

Vaccine. 2013 Oct 17;31(44):5041-6. doi: 10.1016/j.vaccine.2013.08.087. Epub 2013 Sep 8.

Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use.

On lack of expertise-

“As a drug specialist with a more than 30-year experience in safety, I was often missioned as a medical expert witness in criminal or civil inquiries on vaccine litigations, where I repeatedly pointed out the worrying lack of knowledge of most vaccine experts regarding the basic scientific and regulatory requirements normally applicable to pharmaceutical products – esp. as far as adverse reactions were concerned: this represents a tragic shortcoming for such preventive drugs, targeted towards people in perfect health with the problematic aim of protecting them against diseases the occurrence of which in a severe form is often an unlikely event, and for which therefore the risk of side-effects should not go beyond extremely narrow limits… Amongst many others examples, this paper by Tozzi et al. is an impressive illustration of this lack of expertise a far as drug safety is concerned.”

On algorithms-

“To come now to the assessment of causality of individual adverse reactions, the first remark is that the methodological inspiration of Tozzi et al. is regrettably obsolete. The use of algorithms has been almost completely abandoned by most regulatory bodies, for one reason which was pointed out more than 25 years ago …that use of algorithms is a tool for clinical decisions …whereas assessing causality in drug toxicity is a process of knowledge, and not of decision.”

On ingenuity –

After all and as the authors confess with an astonishing ingenuousness, the main point is it not, to “maintain public confidence in immunization programs”?

Med Hypotheses. 2006;66(1):84-6. Epub 2005 Sep 19.

On Multiple Sclerosis-

“….thus, if one focus on the late significant symptoms, this very long time lag is almost always interpreted as speaking against a vaccine role whereas, when considering the whole of symptoms sequence from its very beginning (i.e. from the time of quite discrete symptoms just after injection), it is on the contrary highly suggestive of a vaccine causality. I have never seen this crucial problem properly taken into account in any database, so that most investigations about the time between vaccination and the onset of MS symptoms are essentially misleading.”

Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. Langer-Gould A.JAMA Neurol. 2014

 

On Hepatitis B Vaccine-

“In spite of a huge number of reports of severe hazards after injection of hepatitis B vaccine (HBV), the issue is regularly raised that no mechanism is available for the development of central demyelinating disorders such as multiple sclerosis (MS). A number of convergent facts, however, suggests that the manufacturing process could introduce HBV polymerase as a contaminant, and then trigger an auto-immune process against myelin in some vaccinated subjects.”

Multiple sclerosis and hepatitis B vaccination: adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence.

Full text

 

Links for Marc Girard and risks of Hep B vaccine.

Why medical journals must make researchers share data from clinical trials

From the Conversation July 6 2015

BMJ Acting Head of Research and Associate Professor of Neurology at Harvard Medical School

This month a new BMJ policy on sharing data from clinical trials takes effect. From July 1 2015, the authors of all clinical trials published by the journal must agree to make individual patient data from the trial available to other researchers upon reasonable request. Among major medical journals, only PLOS also requires data sharing as a condition of publication.

An additional benefit of wider sharing of data from clinical trials is that it might help restore trust in the clinical research enterprise. At present, according to the Center for Information and Study on Clinical Research Participation: “Public sentiment toward the clinical research enterprise is at an all time low … more than 70% of Americans believe that drug companies put profits ahead of patient needs.”

It is important to counter cynicism about medical research. If patients and doctors lack confidence in medical evidence, what hope is there for evidence-based medicine? If the evidence on which guidelines and recommendations are based is not trusted, how likely is it that doctors will apply therapies or act in other ways that are consistent with the best evidence?

read the rest of the article here

Pertussis vaccine – under vaccine selection pressure? Resource page

Any cause that reduces reproductive success in a proportion of a population potentially exerts evolutionary pressure or selection pressure.With sufficient pressure, inherited traits that mitigate its effects—even if they would be deleterious in other circumstances—can become widely spread through a population – Wikipedia

A resurgence of pertussis or whooping cough has been observed in highly immunized populations. Studies have shown that there are other causes beyond increased awareness of disease, use of better diagnostic tools and improved surveillance methods. Waning vaccine-induced immunity (secondary failure) has been identified in many countries and antigenic divergence has been found between vaccine strains and clinical isolates in many countries with high vaccination coverage.

Here are the links to some studies that identify vaccine selection pressure / antigenic divergence as a cause for pertussis re emergence.

 http://www.ncbi.nlm.nih.gov/pubmed/11485646

Adaptation of Bordetella pertussis to vaccination: a cause for its reemergence?

In the Netherlands, as in many other western countries, pertussis vaccines have been used extensively for more than 40 years. Therefore, it is conceivable that vaccine-induced immunity has affected the evolution of Bordetella pertussis. Consistent with this notion, pertussis has reemerged in the Netherlands, despite high vaccination coverage. Further, a notable change in the population structure of B. pertussis was observed in the Netherlands subsequent to the introduction of vaccination in the 1950s. Finally, we observed antigenic divergence between clinical isolates and vaccine strains, in particular with respect to the surface-associated proteins pertactin and pertussis toxin. Adaptation may have allowed B. pertussis to remain endemic despite widespread vaccination and may have contributed to the reemergence of pertussis in the Netherlands.


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1828859/

Antigenic Divergence between Bordetella pertussis Clinical Isolates from Moscow, Russia, and Vaccine Strains

Together with waning immunity, the antigenic divergence between vaccine strains and clinical isolates observed in the Moscow area may explain the persistence of pertussis, despite the high rates of vaccine coverage.

In the past few years, the pertussis epidemiological situation in Russia has been unfavorable. Regardless of the high rates of vaccination coverage for pertussis, we have registered an increase in the incidence of pertussis among school-aged children,  along  with  persistently  high  incidences  among  infants under 12 months of age. In addition, some cases of pertussis have been registered among vaccinated children (8, 23). Similar trends have been observed in many other countries (1, 2, 5, 6, 10). Researchers point to many reasons for the increased incidence of pertussis, including improved surveillance, waning immunity, and pathogen adaptation. The last possibility is supported by the fact that divergence in the protective antigens pertussis  toxin  (Ptx)  and  pertactin  (Prn)  has  been  observed between  vaccine  strains  and  the  strains  circulating  in  many countries


http://www.ncbi.nlm.nih.gov/pubmed/18816412

Bordetella pertussis isolates in Finland: serotype and fimbrial expression.

  1. pertussis continues  to  cause  epidemics  in  vaccinated populations  in  spite  of  high  vaccination  coverage.  As  a result  of  this  study  we  gained  more  information  of  the possible mechanisms the bacterium uses to infect highly vaccinated populations. This information is important for the future development of vaccines against pertussis.

Conclusion

Despite  extensive  vaccinations  in  Finland,  Fim2  strains were  the  most  common  serotype.  Fim3  strains  emerged since 1999 and the emergence coincided with nationwide epidemics. In a population with long-term vaccinations, Fim2 strains could express Fim3 during infection, showing a difference in fimbrial expression between in vivo and in vitro.


http://www.ncbi.nlm.nih.gov/pubmed/24757216

Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination.

Pathogen adaptation is suggested by antigenic divergence between vaccine strains and circulating strains and by the emergence of strains with increased pertussis toxin production.

We show that global transmission of new strains is very rapid and that the worldwide population of B. pertussis is evolving in response to vaccine introduction, potentially enabling vaccine escape.


http://www.ncbi.nlm.nih.gov/pubmed/19158267

Changes in genetic diversity of the Bordetella pertussis population in the United Kingdom between 1920 and 2006 reflect vaccination coverage and emergence of a single dominant clonal type.

This supports a hypothesis that MLVA-27 is under some form of positive selection conferring increased survival in a highly vaccinated population.


http://jid.oxfordjournals.org/content/early/2014/12/08/infdis.jiu665.abstract

Genomic analysis of isolates from the UK 2012 pertussis outbreak reveals that vaccine antigen genes are unusually fast evolving

Importantly, we demonstrate that acellular vaccine  antigen encoding genes are evolving at higher rates than other surface protein encoding genes. This was true even prior to the introduction of pertussis vaccines, but has become more pronounced since the introduction of the current acellular vaccines.

The fast evolution of vaccine antigen genes has serious consequences for the ability of current vaccines to continue to control pertussis.


http://www.ncbi.nlm.nih.gov/pubmed/9453625

Polymorphism in the Bordetella pertussis virulence factors P.69/pertactin and pertussis toxin in The Netherlands: temporal trends and evidence for vaccine-driven evolution.

These results suggest that vaccination has selected for strains which are antigenically distinct from vaccine strains.

There is evidence that the incidence of pertussis is increasing in populations vaccinated with WCVs (1, 4, 5, 11, 12), and our results suggest that one of the factors which has contributed to this phenomenon may be the decline of vaccine efficacy due to antigenic shifts in the B. pertussis population. Our findings also may have implications for the efficacy of ACVs, many of which contain  both  P.69  and  pertussis  toxin  (35).


http://www.ncbi.nlm.nih.gov/pubmed/22717007

Evolution of French Bordetella pertussis and Bordetella parapertussis isolates: increase of Bordetellae not expressing pertactin.

Hence, the generalized use of wP vaccine revealed polymorphisms within the B. pertussis population because it was not able to control all the circulating isolates [13]. The wP vaccine-induced herd immunity enabled isolates, as virulent as but different from the vaccine strains, to emerge [3].

In conclusion, even though genetic rearrangements took place in the absence of human interference [28], human vaccination strategies introduced a new challenge that bacterial populations had to overcome, promoting evolution and selection among these populations. It is clearly known now that in France, wP vaccination favoured genotypic changes (PFGE IV, ptxP3, prn2, ptxA1) in the B. pertussis population [6,7], changes which could not be observed in regions of low vaccine coverage (Senegal) [21]. Gene loss (RDs) and increase in insertion sequence elements are also part of the adaptation of the B. pertussis population to its host. Whether they are influenced by vaccination should be appreciated in regions with no or very low vaccine coverage. Continuous surveillance for antigenic change in B. pertussis and B. parapertussis strains is therefore required as a tool for monitoring pertussis vaccine effectiveness.


http://www.ncbi.nlm.nih.gov/pubmed/16048777

Pathogen adaptation under imperfect vaccination: implications for pertussis.

Inspired by pertussis, we study, by means of an epidemic model, the population and evolutionary dynamics of a pathogen population under the pressure of vaccination.


This is exemplified by figure 1 (bottom panel),which shows the estimated incidence in vaccinated and unvaccinated children aged 5–9 years. This panel shows
that, although the incidence in unvaccinated children (ca 4% of the population) has increased considerably since 1995, the incidence in vaccinated children (ca 96% of the population) has increased much more strongly. As a result, the incidences in the vaccinated and unvaccinated cohorts are at present not significantly different.


Flu shots – what do the experts say?

Epidemiologist Tom Jefferson of the Cochrane Collaboration says he’s not anti-vaccine, but he is anti-poor evidence. The Cochrane Collaboration is a highly regarded, international, not for profit network which evaluates research on a topic and provides independent, unbiased information.

Jefferson maintains that large studies have not been carried out to see just how effective flu vaccines really are, or aren’t. One rationale often used is that it is unethical to give a placebo. Jefferson says if that is a problem, then why aren’t studies randomized against masks, hand-washing or gloves? These measures have been proven to work against all strains of the flu, unlike vaccines.

Some of the studies Jefferson has examined have patently ridiculous conclusions. One which looked at at flu vaccines for the elderly found that the shot protected not only against influenza, but against death from stroke, hypothermia, accidents, heart attack and in fact most common causes of death. It would be a modern medical miracle if it were real.

The Cochrane systematic review found almost three quarters of studies were considered to be of poor quality with ‘overoptimistic’ conclusions, or in other words, the results and the summary don’t tally. Higher quality and government funded studies were less likely to favour vaccines.

Regarding pandemic predictions, Jefferson says that the new WHO definition of pandemic omits that it should cause a large amount of illness or death in a population. It’s now just a new virus which transmits quickly and that we have low immunity to. In fact he feels there is an industry built around these predictions, few of which have any substance. In actuality the amount of people who catch or die from influenza is overestimated, with only 7-15% of influenza like illnesses being attributable to the virus. Much of what we think is the flu is not, and physicians and patients alike cannot tell the difference without specialised testing. Vaccines aren’t any use against these ‘influenza like illnesses’ (ILI) – comprised of up to 200 different pathogens – as they are only protective against certain strains of the flu. Government campaigns to promote flu shots provide ‘data’ purporting to show large amounts of illness and deaths attributed to the flu; but in reality they are unsure how much of it is flu and how much is ILI as surveillance systems cannot differentiate.

Peter Doshi is an assistant professor of pharmaceutical health services research in the School of Pharmacy at the University of Maryland and associate editor at The BMJ. He has worked with the Cochrane Collaboration since 2009 reviewing antiviral drugs for influenza.

In a 2013 feature which ran in JAMA on the flu, Doshi said that “the disease is less fearful than advertised, the vaccines are less beneficial than believed, and the harms of vaccines are not easily dismissed.” He cited the Australian Fluvax debacle and the European narcolepsy fiasco as examples of safety concerns. Doshi also contends that influenza vaccines are aggressively marketed with very little evidence that they work. He calls it ‘disease mongering’ – sales tactics which try to increase the uptake of new products and to make you think that pharmaceuticals should be a normal part of everyday life.

And yes it was also Doshi who worked on the Cochrane Collaboration review of Tamiflu which found that there was a ‘paucity of good data’ supporting the claim that Tamiflu reduced complications from the flu. In addition he campaigns for transparency from the drug companies, asking them to hand over data on clinical trials.  As you can imagine, these activities make him a target for vaccine proselytizers.

Vaccine evangelist/science blogger Skeptical Raptor, disses Doshi when he claims he is not on the faculty at Maryland (he is) and suggests that he doesn’t have a background in research despite the fact that the BMJ and Cochrane Collaboration feel he is amply qualified to comment on these matters. After all he is not doing ‘research’ in the lab, and never claims to have – he is reviewing research that is already available and finding it somewhat lacking. Skeptical Raptor writes so often about Peter Doshi that one must assume that he feels his ‘debunking’ has failed and he needs to back it up with more misinformation.

Doshi is not the only target for the science bloggers- Orac or David Gorski who describes himself as a surgeon/scientist has had a go at Tom Jefferson. On his page’ Respectful Insolence’ Orac’s best attempt to disparage him boiled down to a) he’s a boring dinner companion and b) “Jefferson typically fails to consider the totality of evidence into context and draw conclusions based on more than a very narrow set of observations.”

Considering that Jefferson’s review of flu studies encompassed 274 papers published between 1948 and 2007, I am unable to understand how this fails to consider the totality of evidence, but there you  go, vaccine zealots are undeterred by credible reviews carried out by credible researchers.

References

Do Flu Vaccines Really Work? A Skeptic’s View

Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review

Der Spiegel 07/21/2009

Interview with Epidemiologist Tom Jefferson

‘A Whole Industry Is Waiting For A Pandemic’

 

 Dr Tom Jefferson on influenza vaccination

 

 Influenza Vaccines Time for a Rethink

 

 Influenza: marketing vaccine by marketing disease

 

Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis

The Cochrane Collaborative’s Tom Jefferson makes the huge mistake of appearing on Gary Null’s show

VACCINE DENIERS MISUSE THE PETER DOSHI FLU VACCINE STUDY

Human Cell Lines used in Vaccines

To create a vaccine you need a method to propagate quantities of the bacterium or virus. In the early days of vaccine production, calves were used to produce cox pox virus and even into the mid 20th century pathogens continued to be grown in live animals or animal cells. After the discovery of viruses like the SV40 in animal cells, focus shifted to the viability of human cell lines in the late 60’s. WI-38 and MRC-5 are the two main human cell lines used in vaccine development, with Hepatitis A, rubella, varicella, zoster and MMR being the most commonly used vaccines created with the use of these lines.

Influenza vaccines are still made today using hen’s eggs with the embryo removed, a technology developed in the forties. This method is rather slow and dependant on a continuous supply of hen’s eggs, and is not compatible with the industry’s need to produce vast quantities of vaccines in a short space of time assuming that some of those mythical pandemics eventuate. But human cell lines also have limitations; they will only replicate a certain number of times before dying. This is where tumour cells come in; cancer is all about limitless multiplication of cells which is a handy attribute for vaccine makers.  In the lab this infinite replication translates to a higher yield at a lower cost.

In 2001 a paper on the FDA website outlined some concerns about the use of human cancer cells or designer cells as they called them, for manufacturing viral vaccines.

“Residual DNA in vaccines derived from tumorigenic cells….can pose potential risks to the vaccine recipient in two respects: oncogenicity and infectivity” Oncogenicity is the ability to induce tumours, and infectivity is the capacity to spread disease. Neither of which would seem to be desirable traits.

“..the incoming DNA could integrate into the host genome in certain genes…. tumor suppressor genes, which are involved in cell cycle control among other cellular processes. Loss of function of tumor suppressor genes has been associated with certain human tumors.” Fully functional tumor suppressor genes are something that I think we all would like to keep.

Currently the FDA have an industry guidance document which require the manufacturers to demonstrate that the final product is free of the introduced viral sequences. But get this – “Tumorigenic or tumor-derived cell lines for which the mechanism of transformation is unknown will require additional testing to ensure the absence of potential transforming and oncogenic agents”. Surely it will be more difficult to rid the product of something when you are not sure exactly what it is you’re looking for.

Another problem is the presence of adventitious agents ie any type of virus, bacteria, mycoplasma or TSE (mad cow disease) that you didn’t know was likely to be in there. SV 40 found in early polio vaccines is an example.

In 2013 a company called PaxVax gained FDA approval for A549 cell substrate in human clinical trials. A549 was produced from the culturing of a cancerous human lung tissue. PaxVax plan to produce the H5 Pandemic flu vaccine using this cell line. So don’t forget to rush out and get your flu shot next winter, chances are it might be made using this technology.

References

Current and Emerging Cell Culture Manufacturing Technologies for Influenza Vaccines

Medical research: Cell division

“Designer” Cells as Substrates for the Manufacture of Viral Vaccines

A549: Taking Viral Vaccine Production to the Next Level

Matrix and Backstage: Cellular Substrates for Viral Vaccines

Human Cell Strains in Vaccine Development

vaccine excipients

Cell-Culture-Based Vaccine Production: Technological Options

Guidance for Industry

Characterization and Qualification of

Cell Substrates and Other Biological

Materials Used in the Production of Viral

Vaccines for Infectious Disease

Indications

The Cutter Incident – Polio vaccination in the 1950’s

Polio was never as lethal as described by the media, not even at its zenith in the 40’s and 50’s. Depending on who you consult, between 72% and 95% of polio cases are asymptomatic, which means you were unaware that you even had polio. Ten times more children died in accidents and three times as many died of cancer, but the National Foundation for Infantile Paralysis made sure that polio had enhanced media coverage. They not only portrayed polio as a monster, but a monster that could be easily vanquished. Using the latest techniques in advertising and fund raising resulted in huge donations to achieve this goal and in turn resulted in a rush to produce the vaccine. The National Foundation’s crusade to eliminate polio had created a huge public demand for the vaccine and now safety was taking a back seat. David Oshinsky and George Littlefield, authors of ‘Polio, an American Story’ found that “…during the 1954 trials it had taken an average of four weeks for each lot of polio vaccine to be deemed safe for public use, in 1955 it took less than a day.”

Albert Sabin (who went on to develop the Oral Polio Vaccine in 1961) felt that licensing of the Salk vaccine had been done with speed, not safety as the dominant concern. When he read the Francis report about the new Salk vaccine, he found that during the vaccine trials in 1954 there had been reports of at least 10 cases of paralytic polio in the first month. Yet the report still declared – “The vaccine works. It is safe, effective, and potent.”
The vaccines were triple tested for safety by the NIH, by Salk’s laboratory and by the companies themselves. When Dr Bernice Eddy (who also detected the SV40 virus) tested the vaccines on monkeys, they became paralysed. She informed her superiors that the infected lots came from Cutter laboratories, and showed them photos of the monkeys. Her concerns were swept aside, the monkeys disposed of, and the vaccines released onto an unsuspecting public.
The Cutter incident was caused by the laboratory’s inability to inactivate the polio virus, which should have come as no surprise as it was known that all of the six companies selected by Salk to produce the vaccine for the 1954 trials had trouble inactivating the live virus. Cutter Laboratories knew that about one third of the vaccine lots produced for commercial use contained live virus and they discarded these lots without informing the NIH.
When reports of paralysis in vaccinated children started to roll in a mere two weeks after the vaccine had been licensed, Cutter was asked to recall the doses by Surgeon General Leonard Scheele. The press release from Scheele stated that the recall “..does not imply that any correlation exists between the vaccine and the occurrence of poliomyelitis.”
There was a halt put on all further inoculations until all the vaccine manufacturers had been scrutinized. Even Eisenhower speculated that due to the demand for vaccine, scientists may have tried to “short cut a little bit” on safety tests.

In the end it was ascertained that the Cutter Laboratory vaccine was responsible for 40,000 cases of polio, which paralysed 200 children, and killed 10.

References:

Francis report

Polio : An American Story
By David M. Oshinsky George Littlefield Professor of History University of Texas at Austin

The Cutter Incident: How America’s First Polio
Vaccine Led to a Growing Vaccine Crisis
Reviewed by Michael Fitzpatrick

Asymptomatic polio 

Asymptomatic polio CDC

Waning immunity – Pertussis vaccination resource page

A resurgence of pertussis or whooping cough has been observed in highly immunized populations. Studies have shown that there are other causes beyond increased awareness of disease, use of better diagnostic tools and improved surveillance methods. Waning vaccine-induced immunity (secondary failure) has been identified in many countries. Secondary failure is when a person produces antibodies after vaccination, but the levels decline or wane over time.(Primary failure is when a person fails to make antibodies or doesn’t reach a level considered to be protective.)

Here are links to some of the studies that refer to waning immunity / secondary failure associated with the Pertussis vaccination.

http://www.ncbi.nlm.nih.gov/pubmed/23188029

Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010.

In 2010, California experienced its largest pertussis epidemic in more than 60 years; a substantial burden of disease was noted in the 7- to 10-year-old age group despite high diphtheria, tetanus, and acellular pertussis vaccine (DTaP) coverage, indicating the possibility of waning protection.

http://www.ncbi.nlm.nih.gov/pubmed/25184820

Characteristics of pertussis outbreaks in Catalonia, Spain, 1997 to 2010.

Between 2003 and 2010, after the introduction of the acellular vaccine, the index case was vaccinated with DTwP vaccine in 25 outbreaks (0.43 × 10-6 persons-year) and with DTaP vaccine in 32 outbreaks (0.55 × 10-6 person-year) (RR = 0.78, 95% CI 0.46-1.31; P = 0.35). Of cases, 37.2% were correctly vaccinated, suggesting waning immunity of pertussis vaccine protection and endogenous circulation of pertussis. A greater number of outbreaks had an index case aged

http://www.ncbi.nlm.nih.gov/pubmed/25560446

Duration of pertussis immunity after DTaP immunization: a meta-analysis

Pertussis incidence is increasing, possibly due to the introduction of acellular vaccines, which may have decreased the durability of immune response.

Assuming 85% vaccine efficacy, we estimated that 10% of children vaccinated with DTaP would be immune to pertussis 8.5 years after the last dose.

http://www.ncbi.nlm.nih.gov/pubmed/25621762

Effectiveness of routine and booster pertussis vaccination in children and adolescents, federal State of Brandenburg, Germany, 2002-2012.

In Germany whole-cell pertussis vaccines (wP) were rapidly replaced by high-concentration acellular pertussis-containing vaccines (aP, 3+1 doses) starting in 1995. Boosters were recommended for 9-17 year-olds (2000) and for 5-6 year-olds (2006). Pertussis incidence remains high despite rising vaccination coverage

http://www.ncbi.nlm.nih.gov/pubmed/21034823

Imperfect vaccine-induced immunity and whooping cough transmission to infants

However, by the 1970s, most people obtained immunity through vaccination rather than transmissible natural infection. With so little circulating pathogen people’s immunity wasrarely boosted, thereby creating a large pool of people susceptible to pertussis, and allowing epidemic outbreaks in the current era despite high vaccine coverage. Another potential explanation is that vaccine-driven pathogen evolution selected for a strain that can infect more quickly or symptomatically after vaccination [26].

http://www.nejm.org/doi/full/10.1056/NEJMoa1200850

Waning Protection after Fifth Dose of Acellular Pertussis Vaccine in Children

….indicating that after the fifth dose of DTaP, the odds of acquiring pertussis increased by an average of 42% per year.

CONCLUSIONS

Protection against pertussis waned during the 5 years after the fifth dose of DTaP.

http://pediatrics.aappublications.org/content/early/2013/03/06/peds.2012-1928.abstract

Waning Immunity to Pertussis Following 5 Doses of DTaP

CONCLUSIONS: This evaluation reports steady increase in risk of pertussis in the years after completion of the 5-dose DTaP series. This rise is likely attributable in part to waning immunity from DTaP vaccines. Continuing to monitor disease burden and vaccine effectiveness in fully vaccinated children in coming years will be important to assess ongoing risk as additional cohorts vaccinated solely with acellular pertussis vaccines are introduced.

http://www.ncbi.nlm.nih.gov/pubmed/25483496

Licensed pertussis vaccines in the United States.

….to review evidence that waning protection following licensed acellular pertussis vaccines have been significant factors in the widespread reappearance of pertussis.

http://www.ncbi.nlm.nih.gov/pubmed/25316461

Pertussis. A reemerging and an underreported infectious disease.

Pertussis resurgence has been observed in highly vaccinated populations of Western countries since 1990s. Poor vaccine quality, waning vaccine induced immunity, pathogen adaptation, and enhanced surveillance as well as advancements in diagnostic facilities are some of the reasons considered responsible for the increased reporting of pertussis cases.

http://www.ncbi.nlm.nih.gov/pubmed/20822735

Pertussis outbreak in northwest Ireland, January – June 2010

Epidemiological  investigations  suggest  that waning  immunity  and  the  absence  of  a  booster  dose during  the  second  year  of  life  could  have  contributed to the outbreak.

http://www.ncbi.nlm.nih.gov/pubmed/24066885

Pertussis vaccines: state-of-the-art and future trends.

Waning vaccine-induced immunity and antigenic divergence in circulating strains seem to be the major problems accounting for resurgence of pertussis.

http://www.ncbi.nlm.nih.gov/pubmed/23487373

Reduced risk of pertussis among persons ever vaccinated with whole cell pertussis vaccine compared to recipients of acellular pertussis vaccines in a large US cohort

Unexpected waning of immunity after pertussis vaccination is now well described

We found a markedly increased risk of disease associated with an entirely aP series.

http://www.ncbi.nlm.nih.gov/pubmed/23151168

Resurgence of pertussis calls for re-evaluation of pertussis animal models.

Pertussis has recently re-emerged in well-vaccinated populations most likely due to a combination of pathogen adaptation and waning of vaccine-induced pertussis immunity.

http://www.nejm.org/doi/full/10.1056/NEJMp1209051?query=TOC

Epidemic Pertussis in 2012 — The Resurgence of a Vaccine-Preventable Disease

Recent data from California also suggest waning of vaccine-induced immunity after the fifth dose of DTaP vaccine.5 Certainly the major epidemics in 2005, in 2010, and now in 2012 suggest that failure of the DTaP vaccine is a matter of serious concern.

http://www.ncbi.nlm.nih.gov/pubmed/25093268

Waning vaccine immunity in teenagers primed with whole cell and acellular pertussis vaccine: recent epidemiology.

These epidemics demonstrated a new pattern, with particularly high rates of disease among pre-adolescents and early adolescents. These high rates of pertussis coincided with the first cohorts vaccinated with purely acellular pertussis vaccine

http://www.ncbi.nlm.nih.gov/pubmed/16221076.

Are vaccination programs and isolate polymorphism linked to pertussis re-emergence?

More likely explanations for the re-emergence of pertussis include the change in the epidemiology and transmission patterns of pertussis in highly vaccinated populations, and a shift of disease from young children to adolescents and adults due to waning protective immunity.

http://www.ncbi.nlm.nih.gov/pubmed/24530743

Substantial gaps in knowledge of Bordetella pertussis antibody and T cell epitopes relevant for natural immunity and vaccine efficacy.

The recent increase in whooping cough in vaccinated populations has been attributed to waning immunity associated with the acellular vaccine.

We conclude that the cumulative data is yet insufficient to address many fundamental questions related to vaccine failure and this underscores the need for further investigation of B. pertussis immunity at the molecular level.

http://cid.oxfordjournals.org/content/54/12/1730

Unexpectedly Limited Durability of Immunity Following Acellular Pertussis Vaccination in Preadolescents in a North American Outbreak

Our unvaccinated and under-vaccinated population did not appear to contribute significantly to the increased rate of clinical pertussis. Surprisingly, the highest incidence of disease was among previously vaccinated children in the eight to twelve year age group. We sought to examine the factors that resulted in this peak.

Conclusions. Our data suggests that the current schedule of acellular pertussis vaccine doses is insufficient to prevent outbreaks of pertussis. We noted a markedly increased rate of disease from ages 8–12 years, proportionate to the interval since the last scheduled vaccine. Stable rates of testing ruled out selection bias. The possibility of earlier or more numerous booster doses of acellular pertussis vaccine either as part of routine immunization or for outbreak control should be entertained.

How to write a pro vaccine article

Here’s a great example  X

This is what I took away from “California Set to Mandate Childhood Vaccines Amid Intense Fight” in the New York Times.

1# Interview people who can’t have vaccines, and talk about their rights, but ignore the rights of those who are vaccine damaged.

2# Repeat the ‘science is settled’ or similar as often as possible.

3# Say that measles, mumps and rubella have almost been eliminated by vaccines and pretend that with mandatory vaccination these diseases will disappear altogether.

4# Call the arguments of those who resist vaccination mandates – ‘emotional debates’

5# Mention the autism vaccine link as a) being discredited, and b) as the main reason that people don’t vaccinate

6# Mention herd immunity (relating to vaccination not naturally acquired disease) as if is a fact and not a theory.

7# Wheel out an expert to say vaccines are safe and responsibility to public health overrides individual choice.

8# Make out that immunization rates are low, when in reality California has vaccine coverage above 92% for each vaccine at all schools.

#9 Blame unvaccinated children for the rise in pertussis cases*, oblivious to the science which shows that waning immunity, vaccine selection pressure and asymptomatic vaccinated pertussis carriers are the real cause.

* they forgot to do this, but I thought I’d add it in anyway for good measure.