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Dr Jacob Puliyel Blows Whistle On Indian Rotavirus Vaccine Trials

Dr. Jacob PuliyelBy John Stone

Please sign and circulate petition, and read new article at CHS.

Vaccine safety proponent Jacob Puliyel (consultant paediatrician at St Stephen’s Hospital, Delhi) has drawn attention in the Hindu newspaper  to malfeasance in trials for an Indian rotavirus vaccine. It is proposed to conduct a trial involving 100,000 infants when the data from an earlier smaller trial has been suppressed (the report refers to a lakh which is an Indian unit of 100,000). Puliyel comments in the report:

“Peer reviewed journal Vaccine, published a letter written by me and a colleague, asking for disaggregated data on the number of intussusceptions in Vellore in the randomized control trial during the 2 year study period. The protestation of the authors that the vaccine is safe has little meaning if they do not provide the data. However, the data is not available in the papers published and the peer reviewer of Vaccine and the Editor of this international journal felt that it needs to be provided. Serious concerns are raised if safety data in a vaccine trial done with Government of India funding is not provided in spite of a call for it in an internationally indexed scientific journal.”

In an earlier intervention on Pubmed (14 August 2014) Puliyel quoted actual figures:

Licensing the vaccine for general use (in remote areas of India), seems impossible to justify

I commend Dr John and colleagues for this report on the trial with the 116E Indian rotavirus vaccine. However the authors limit their discussion to comparisons with the trials of Rotarix and Rotateq which recruited some 60,000 patients each. It will be more useful to compare the 116E trial safety results with the RotaSheild vaccine trials http://www.path.org/vaccineresources/files/RotaShield_Fact_Sheet_CDC.pdf.

RotaSheild trial

The RotaSheild trial recruited double the numbers recruited in the present 116E study. RotaSheild was licensed after the trial involving 14,687 patients (10,054 received the rotavirus vaccine and 4,633 received placebo). In the study there was one case of intussusceptions among the 4633 receiving placebo. This suggests that the ‘normal rate of intussusception’ was approximately 2/10,000, in that population. Five cases of intussusceptions occurred among 10,054 RotaSheild vaccine recipients. Thus there were an excess of 3 cases of intussusceptions for each 10,000 children vaccinated. All the intussusceptions were among infants who received a second or a third dose of vaccine. The difference between the vaccinated and placebo recipients was not statistically significant http://www.path.org/vaccineresources/files/RotaShield_Fact_Sheet_CDC.pdf.

116E Trial

With the 116E vaccine trial there were 6 cases of intussusceptions in 2267 controls which works out to be 2.6 cases per 1000 placebo recipients. The ‘normal rate of intussusception’ in this study was at least 10 times higher than the RotaSheild trial (where it was 0.2 cases per 1000 placebo recipients). There were 17 cases of ultrasound confirmed intussusceptions among the 4532 given the 116E vaccine which is 3.75 cases per 1000 babies vaccinated. The comparative figure for the RotaShield study was 0.5 cases/1000. In the 116E trial there was an excess of 1 case of intussusceptions for every 1000 children vaccinated with the rotavirus vaccine (compared to the RotaSheild trial where there were 3 excess intussusceptions per 10,000 vaccinated). RotaSheild vaccine was withdrawn after licensing, on account of unacceptable risk of intussusception. The risk of intussusception in the 116E trial was three times higher than with the RotaSheild trial. We are told that in the 116E trial, 50% intussusceptions diagnosed by ultrasound, resolved spontaneously John J, 2014. In the remaining 50% there is need for urgent treatment by a radiologist or pediatric surgeon. In remote parts of India, without motorable roads, let alone radiologists and pediatric surgeons, mortality will be near 100% http://emedicine.medscape.com/article/930708-overview. Such specialized care (radiological or surgical reduction of intussusception) is not available in vast swathes of India and we can assume vaccinated babies would die at home passing blood and mucus in the stools and it will be presumed they had died of dysentery and sepsis rather than intussusception caused by the vaccine.

Intussusception risks compared to diarrhea deaths avoided

Assuming only 50% ultrasound diagnosed intussusceptions need urgent treatment John J, 2014 we can assume that one child in 2000 vaccinated babies will develop this life threatening condition. The possible harm in remote areas (deaths from intussusceptions 1/2000) is not offset by benefits (diarrhea deaths avoided using the 116E vaccine).

In the first two years after vaccination, there number of infants that needed to be immunized to prevent one episode of rotavirus diarrhea of any severity was 21 Bhandari N, 2014. Assuming mortality from rotavirus diarrhea to be 1% in the first 2 years of life with community management Lal S, 1994 Kosek M, 2003 2100 babies will have to be vaccinated to prevent one death from diarrhea in the first 2 years of life.

When 2100 babies are vaccinated to prevent that 1 death from rotavirus diarrhea - 1 child will have intussusceptions and die in remote areas of the country. This is why, given the limited evidence of this 116E trial, licensing the vaccine for general use (in remote areas of India), seems impossible to justify.

Although Rotashield vaccine has long been withdrawn the two current US products (GSK’s Rotarix and Merck’s Rotateq of which Paul Offit was part inventor) are also associated with intussusception, mortality and contamination with pig viruses, despite which the FDA the continues to license them.

John Stone is UK Editor for Age of Autism.

Note added May 14, 2015. Please sign and circulate petition, and read new article at CHS.

Comments

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John Stone

Please sign Avaaz petition:

https://secure.avaaz.org/en/petition/To_The_Director_Christian_Medical_College_Vellore_632004_Release_Indian_Rotavirus_Vaccine_Trial_Data/

See new article at CHS

https://childhealthsafety.wordpress.com/2015/05/14/rotavirus_petition/

Please circulate.

John

Just saying: I was old enough to remember my vaccine episode (Sept 1970, I was 5 years old). The "culture" back then was deny, deny, deny. And if that didn't work, lie.
My wife's eldest child had over 30 seizures from the DPT (later found in hospital records), but at the time, she was told she was a nervous new mother and her dog just scared him.

How many others are told the same lies?

In 1970, the doctors said there was nothing wrong when my mother told the intake nurse that I had progressive pain in and progressing up my forearms, less use of my hands over the previous weeks, and greater difficulty in breathing since the MMR booster. By September, I was in an oxygen tent, great birthday present for a five year old! In about 1996, almost verbatim to what my mother told the intake nurse was published a type of GBS (Guillain-Barre Syndrome) in Cambridge University Press, but my mother didn't use specific scientific & medical terms, she was just smart as a tack!

Also my job, first and foremost is to protect my son! And I will not let them do to him, what they did to me. In fact, I'm still suffering the consequences of what they did (in 1998, after a MRI, I was told I have active demyelination of the nerves in my brain, and was having mysterious seizures). That's about 28 years after a certain political figure told my parents that this is "how we do business now", I listened, but did not understand what those conversations meant, now I do! That's exactly 28 years since my medical records showed no history of allergies or asthma, that was 28 years since unimaginable pain was induced in me with GBS, now almost 45 years since this all started, but I remember vividly.

LN

Why are drug companies conducting experimentation on human test subjects when serious, likely fatal adverse reactions are occuring? Did they forget to FIRST conduct experiments on animals to rule out potentially fatal adverse reactions BEFORE moving on to human trials? This is in violation of the Nuremberg Code! Were the parents of all of those human test subject babies FULLY informed beforehand that there was a known risk of potentially fatal adverse reactions? If they weren't, then that is ALSO a violation of the Nuremberg Code.

Read about the Nuremberg Code yourself: http://www.nejm.org/doi/full/10.1056/NEJM199711133372006#ref6

John Stone

Nonnymouse

Thank you - have corrected.

Edda West

Dr. Puliyel has been criticizing the effects of India's aggressive vaccination programs for some time: http://jacob.puliyel.com/ This article discusses his suspicion that continuous rounds of oral polio vaccine are driving the surge of acute flaccid paralysis in India: http://jacob.puliyel.com/download.php?id=251 He writes, " In 2011, an additional 47,500 children were newly paralysed in the year, over and above the standard 2/100,000 non-polio AFP that is generally accepted as the norm. (32-33). It is sad that, even after meticulous surveillance, this large excess in the incidence of paralysis was not investigated as a possible signal, nor was any effort made to try and study the mechanism for this spurt in non-polio AFP. These findings point to the need for a critical appraisal to find the factors contributing to the increase in nonpolio AFP with increase in OPV doses – perhaps looking at the influence of strain shifts of entero-pathogens induced by the vaccine given practically once every month."

Additional analysis of non-polio acute flaccid paralysis in India: http://vaccinechoicecanada.com/in-the-news/paralysisdeath-surge/

nonnymouse

John Stone -

You don't mean lakhmi. You mean lakh. Lakhmi is a woman, a goddess. Lakh is a number.

Jeannette Bishop

Thank you, John, and Dr. Puliyel.

david m burd

Thank goodness we have doctor/scientist Dr. Puliyel citing specific stats, and not afraid to speak up. However, the "placebos" mentioned may or may not have been genuine placebos (nothing but saline solution) OR corrupted placebos that use another vaccine, or such, as a so-called placebo. NO elaborations of the placebos were revealed.

I know I'm a "broken record" on this placebo topic, BUT, the U.S. history of the last many decades when testing vaccines has been to NEVER use a true placebo (with one non-American exception that is published by Hong Kong testing a flu vaccine).

So, in India, all the data revealed by Dr. Puliyel might be even more catastrophic as to the deadly outcome(s) of the tested vaccines.

The CDC and the NIH and Phama makers of vaccines have effectively lied for decades as to their "Studies" and "Trials" -- yet I'm sure the average American doctor or pediatrician has put their trust in such corrupt Agencies.


Linda

Yes well once you take blind faith out of the equation the voice of reason prevails. That is exactly right what are the risks and what are the benefits? That use to be considered common sense and first question asked. We definitely need more of this.

Truthseeker2

Will "Science"blogs conveniently ignore these statistics???

Bob Moffitt

"When 2100 babies are vaccinated to prevent that 1 death from rotavirus diarrhea - 1 child will have intussusceptions and die in remote areas of the country. This is why, given the limited evidence of this 116E trial, licensing the vaccine for general use (in remote areas of India), seems impossible to justify."

Imagine that .. a doctor actually questioning the conventional wisdom the "benefits" of vaccine .. always outweighs the "risks".

The sad thing is .. the doctor had to exhibit tremendous courage ... and .. probably will pay some type of professional price .. for daring to question the "benefits vs. risk" ratio.

Angus Files

Well done Jacob Puliyel, we need more just like this honest man with a conscience ,something lacking these days from the top down.

MMR RIP

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