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.

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