One Click Note: We publish today the most timely paper on Swine Flu authored by Dr Marc Girard MD, France. Below is the Conclusion of the paper. We suggest to our readers that you peruse the full text. It is most informative.
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Marc GIRARD, MSc, MD
Consultant in drug monitoring and pharmacoepidemiology
European expert (AEXEA)
76 route de Paris, 78760 Jouars-Pontchartrain – France
(agosgirard@free.fr)
site: www.rolandsimion.org
EXTRACT
5. Conclusion
As mentioned above, a positive consequence of the swine flu story could be a radical reappraisal of the ferocious antagonism between vaccine promoters and antivaccinationists. This time, by dint of ignoring the basics of drug development, things went too far – and everybody may notice. It is time now to go back, to understand that vaccines are drugs amongst others, with their potential of hazards and the inherent requirement of a cautious assessment regarding their benefit/risk ratio. It is time now to stop considering that vaccines must be beneficial and that they cannot be risky. It is time to require that the elementary principles of drug development cannot be so grossly ignored as they are nowadays as far as vaccines are considered. It is time to recognize that human body is not a bin for the dangerous gadgets that, through lack of professionalism, Big Pharma develops instead of useful drugs.
In April 2007, on the site of the French Association des médecins de l’industrie pharmaceutique, an association of professionals working for pharmaceutical firm, one of the major vaccine makers posted a job advertisement in English (attached). This was for an appointment of “clinical team leaders, global clinical development, vaccines” – typically the kind of guys that may be now in charge of the development of influenza vaccines. After emphasizing an “excellent salary, bonus and benefits package (including 53 days annual leave)”, the ad turned to the candidate profile: “An understanding of the clinical aspects of infectious diseases – virology, immunology or microbiology would be very useful but is not essential. You need to demonstrate the core interpersonal skills, including international outlook, excellent presentation and communication skills, team leadership, impact and influence (...)” (my italics). The ad was strictly silent on any requirement of a past experience in drug development...
This should be a serious concern for any health professional – and beyond: for any citizen – that, in the vaccine sector, things went so far that manufacturers are not ashamed of publicly advertising that, to develop new vaccines, even a simple “comprehension” (not an expertise!) of infectious disease “is not essential” as compared to smartness (“excellent presentation”), a personal gift for chatter (“communication skills”) and good manners with people (“impact and influence”: preferably with opinion leaders and experts of the governmental agencies?).
No wonder that on the basis of such amateurism, vaccine makers are just able to develop defective products. But, perfectly illustrated by the current story of swine flu, the problem is that they are actively encouraged by health authorities to introduce and maintain their defective products, in blatant contradiction with laws in force34.
How to explain this contradiction between the law on the one hand, and the regulatory practice on the other? In its Directive 65/65/EEC (26/01/65), the Council of the European Economic Community was not afraid to write:
Whereas the primary purpose of any rules
concerning the production and distribution of
medicinal products must be to safeguard public
health;
Whereas, however, this objective must be
attained by means which will not hinder the
development of the pharmaceutical industry
or trade in medicinal products within the
Community
At least in Europe, this was probably the first time in the whole history of pharmacy that a mercantile target was put exactly at the same level as the primacy of public health: when laws are so hypocritically ambivalent in their inspiration, no wonder if their enforcement is schizophrenic in practice35...
By contrast, let us compare the Royal Charter granted by King James I of England to the Society of Apothecaries, in 1614:
(...) very many Empiricks and unskilful and
ignorant men do abide in the City of London, which
are not well instructed in the Art or Mystery
of Apothecaries, but do make and compound many
unwholesome, hurtful, dangerous and corrupt medicine
and the same do sell (...) to the great peril and daily
hazards of the lives of the King’s subjects36
“Unskilful and ignorant” drug makers, “unwholesome, hurtful, dangerous and corrupt medicines”, “great peril and daily hazard” for citizens: which of the royal concerns was not sadly exemplified by the story of swine flu?
Conflicts of interests: Dr Girard works as a consultant for pharmaceutical firms, including manufacturers likely to have an interest in influenza pandemic and (at least until recently...) a number of vaccine makers.
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