A paper published in the Indian Journal of Medical Ethics reveals that the European Medicines Agency [EMA] published what seems clearly to be falsified data about the numbers of children who died after receiving Glaxo Smith Kline’s Infanrix Hexa vaccine. A link to the full journal paper is at the end of this article.
The total numbers of children dying were higher in a prior GSK Periodic Safety Report [PSUR16] than in a later one submitted to the EMA some years later [PSUR19]. This was accepted and published by the EMA clearly without exercising the oversight and scrutiny a supposed drug safety regulator should. But as you will see, the EMA does not perform the duties of a safety regulator at all.
This is not an isolated occurrence for the EMA. The EMA has a track record of cover-up regarding this vaccine as CHS reported in January 2015: Vaccines Proven To Cause Sudden Death in Children – 67 Deaths Only Explicable As Caused By Vaccines – Drug Safety Regulators Had The Information for Over 2 Years And Let Children Die
Like the EMA other Governments agencies also have a record of behaviour like this as reported in formal journal published research. This applies to the US FDA as this paper shows by authors from Harvard University’s Edmond J. Safra Center for Ethics published in the Journal of Law, Medicine and Ethics Vol. 14, No. 3 (2013): Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
The authors state:
It is our thesis that institutional corruption has occurred at three levels. First, through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA). Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid “user fees” since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages. Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.
The UK’s Medicines and Healthcare Products Regulatory Agency is similar as this example shows: UK Drug Safety Agency Falsified Vaccine Safety Data For 6 Million
And it is not the first time the MHRA have done something like that. They did exactly the same with GSK’s Pandemrix vaccine – their published safety analysis was manipulated to hide serious health problems caused by the Pandemrix vaccine just as they did with HPV vaccines. With Pandemrix large numbers of children developed narcolepsy and cataplexy which are life-changing conditions.
Lest no one remains under any illusions this CHS article from 2016 showed how the UK’s MHRA used devious means to block the UK Government’s Ministerial mandated introduction of direct reporting of adverse drug reactions by patients: How Crooked is The UK’s Drug Safety Regulator, The MHRA – The Story of Patient Reporting of Adverse Drug Reactions
No one has been prosecuted. No one in the MHRA ever is.
The authors of the journal paper confirm the deception practised by the EMA over Infanrix Hexa deaths in permitting the deletion of records of the sudden deaths of infants to make it look like there is no causal connection with GSK’s Infanrix Hexa and Sudden Infant Death:
….. deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. ….. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA. “
What this also shows is that Europeans are not safe taking medicines authorised by the EMA. It confirms what many insiders have known for a long time. Organisations like the EMA and the EMA are not drug safety regulators but republishers of whatever information drug companies supply regarding the safety of the drug companies’ pharmaceutical products.
In essence the EMA does not regulate safety and check but just acts as a republishing channel for the drug industry.
It would be interesting to know what the legal liability of individuals in the EMA is for failing to exercise due diligence and oversight to prevent dangerous drug products being given to children. If any reader knows of a journal published or other reliable source explaining the position either post a comment or email CHS@childhealthsafety.com.
Whatever the law is, if it is not already, it should be presumed that such individuals are engaged in corrupt practices unless they prove without doubt they are not.
There have been too many drug scandals resulting in serious injury and death. Some recent well-known examples: Vioxx = deaths, Pandemrix = narcolepsy and cataplexy in large numbers of children.
Jacob Puliyel, C Sathyamala
Published online on September 5, 2017. Corrected on September 9, 2017
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