GSK - Babies Died


The Report highlighting the concealment of childhood post-vaccination deaths


The vaccine in question is "Infanrix hexa", which combines diphtheria, tetanus, pertussis, hepatitis B, polio and type B haemophilus influenzae. It is manufactured by GlaxoSmithKline (GSK), and it was introduced in Europe on October 23, 2000.
The Indian reserchers Dr. Puliyel and Dr. Sathyamala have discovered deleted and hidden data in the Periodic Safety Update Reports (PSURs) for this vaccine, those are the reports that GSK has to regularly provide to the European Medicines Agency (EMA- The European equivalent of the American CDC).

These security reports reserved for this vaccine were sent to Dr. Puliyel from an Italian researcher who obtained them from EMA under the Freedom of Information Act - the Italian version of the right to information in India.

The Indian doctors have discovered that in the latest Infanrix hexa vaccine safety report submitted by GSK (2015), GSK deleted the deaths previously reported in his 16th report (2012). The doctors, however, note that it is unclear in the report how these deaths have been erased.

The authors Dr. Puliyel and Dr. Sathyamala note that ten years after the publication of a CDC article examining the relationship between MMR and autism one of the authors, Dr. William Thompson, admitted that he and his co-authors had omitted information statistically significant - the African American males to whom the MMR had been administered prior to the age of 36 months were at increased risk of autism. After Dr. Thompson and his colleagues found evidence of this increased risk, they deleted data from children without Georgian birth certificates (and therefore disqualified a disproportionate number of black children) and presented their data stating that there was no increased risk of autism. It is unclear whether the authors of PSUR 19 had such a retrospective disqualification of children documented as deceased in PSUR 16.

"If these deaths had not been deleted, deaths after vaccination would have been significantly higher than the case-by-case scenario. The manufacturer should have admitted to EMA that their vaccine was the cause of such excess deaths"

Dr. Puliyel and Dr. Sathyamala argue that the manufacturer “has to explain the apparently bad data he has presented to regulatory authorities”.

Until now, the manufacturer has stated that the deaths reported after the vaccine are "coincidental", and that they would have happened to these children even if they had not received any vaccinations.
However, in their journal review, Dr. Puliyel and Dr. Sathyamala show in their analysis that 83% of the deaths reported occurred in the 10 days immediately following the vaccination, and only 17% occurred in the following 10 days.

"If the deaths were coincidental, then they would not all be grouped immediately after the vaccination, but they would be evenly distributed over the 20-day period post inoculation"

Dr. Puliyel and Dr. Sathyamala state that any argument that sudden deaths after vaccination are compensated by the lives saved by the vaccines is not acceptable, just as it would be considered unlawful to kill a person to use his organs to save the lives of another five people.

In the light of their findings, Dr. Puliyel and Dr. Sathyamala suggest that: The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer’s claims in the PSUR need to be reviewed. 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.


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