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DeStefano Rides Again: GSK Rotavirus Vaccine Study Loses 80% Of Cases And 18 Deaths

DestefanoWe don't often bring back posts this soon, but in light of Robert Kennedy's calling Dr. Frank DeStefano to task, we thought we'd shed some light on his work. Like shining a flashlight in a very dirty kitchen at 2:00am. You know what happens....

Addendum (October 28, 2015)

I took this article down for 24 hours to consider the points made by "n davis" and "n davis is correct". I had overlooked the fact that the paper selects US cases only - that there are only a trickle of cases from the US against a relative flood from abroad - and this is basis of massive selection bias, particularly in relation to deaths. It also shows that the US reporting system while always vastly inadequate is wilting. Pharmaceutical companies are required by law to forward reports from abroad where they come to their attention: there is nothing in n davis's claim that these reports were unavailable to DeStefano - anyone interested in the safety of the vaccine to US children or any other would have considered all of the reports.

http://wonder.cdc.gov/wonder/help/vaers/VAERS%20Advisory%20Guide.htm

By John Stone

Frank DeStefano, the CDC's Director of Immunization Safety and the lead author at the centre of  CDC whistleblower William Thompson’s allegations about destroying  MMR/autism data, is involved in another  case of apparently hiding data, this time  involving intussusception and death, in a newly published paper concerning the safety of GSK’s rotavirus vaccine, Rotarix - a vaccine given according to schedule to infants at 2 and 4 months in the US, and 2 and 3 months in the UK.

Last month Representative Posey revealed Congress that Thompson told Dr Brian Hooker in a taped telephone conversation regarding the DeStefano MMR paper that:

Sometime soon after the meeting, we decided to exclude reporting any race effects, the co-authors scheduled a meeting to destroy documents related to the study.  The remaining four co-authors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can.

The new CDC based study of GSK’s Rotarix vaccine by Haber et al, of which DeStefano is senior author and therefore responsible for research integrity, admits a small association with the serious condition of intussusception (an intestinal obstruction secondary to the inversion of one portion of the intestine within another). The paper states that from February 2008 to December 2014 the Vaccine Adverse Event Reporting System (VAERS) “received 108 confirmed insusceptible reports after RV1” (Rotarix). However, a careful review of the database reveals no less  than 565 cases for the period. The paper claims to have excluded only 4 reports as unconfirmed (making a total of only 112).

This is a gigantic discrepancy bearing in mind that intussusception is not a speculative diagnosis. DeStefano and the CDC team have apparently discarded more than 80% of the cases reported, which in their turn are likely to be only a tiny fraction of actual cases.  VAERS is a passive reporting system   which may report as few as 1 or 2% of cases. It is also astonishing that the CDC would seriously attempt to estimate the excess rate from this data, but not surprising that as a result it is very small. Other recent studies include a meta-analysis which calculated that risk of intussusception was in the region of five and half times for both products in the first week after the first dose, and a study of Rotarix in Japan conducted by GSK itself which showed that intussuception was nearly three times more likely to occur in the week after the first dose  (based only on spontaneous reports).

A further troubling statistic relating to Rotarix from the VAERS database (previously reported on Age of Autism) is that the mortality rate from reported cases of intussusception is more than double that for the rival product , Rotateq.  This is strongly suggestive that cases of intussusception after Rotarix are more serious, and more deadly than with the rival product. While Haber et al mention only 1 death VAERS currently lists 13 deaths related intussusception from the oral vaccine.

The Haber paper mentions that by April 2012 there were 584 reports intussusception on VAERS associated with the Merck Rotateq vaccine launched two years earlier. Again a search of the database reveal 812 cases  - however they also omit to mention 6 deaths.  



It should be noted that both the GSK and Merck products have recently been withdrawn by the French government following adverse reports. It is unlikely that any parent who had lost a child to intussusception following  Rotarix would agree with the CDC’s assessment:

The estimated small number of intussusception cases attributable to RV1 is outweighed by the benefits of rotavirus vaccination.

There is also a general disturbing mortality rate associated with these products although they are seldom administered on their own: a grand total of 448 deaths are currently listed on VAERS for the three products combined, thirteen more than in February.  In France the concerns leading to the withdrawal of the two current products seem to have extended beyond intussusception including a case where a vaccine was thought to be contributory to a death from necrotizing enterocolitis.

It is surprising  - to say the least – that these serious problems did not emerge in pre-marketing trials. Presently, Dr Jacob Puliyel of St Stephen’s Hospital, Delhi is taking legal action to force the Indian government to publish the results of early trials of its homegrown product Rotavac, manufactured by Bharat Biotech. The court has reserved judgment.

In 2010 the FDA suspended the license for Rotarix when it was discovered to be contaminated porcine virus PCV1 but it was rapidly returned to the market when it was discovered that rival product, Rotateq, suffered from similar problems. The current package insert elliptically states:

In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in ROTARIX. PCV-1 is not known to cause disease in humans.

The Rotarix vaccine was placed on the United Kingdom schedule last year in 2014 despite there being no history of illness fatalities in the country in the first thirteen years of the millennium, although there were about 15,000 hospitalizations a year. It appears all too likely that the recently recommended vaccine in the UK may become a net cause of death to save the costs of short hospitalisations for the correction of dehydration resulting from improperly treated rotavirus gastroenteritis cases. Such a policy would not be tenable if it had to withstand wide public scrutiny.

Meanwhile, at the CDC it appears to be business as usual as ever more infants are discarded as human garbage: the collateral damage of an indiscriminate policy which officials are apparently only too keen to cover up on behalf of their government. If you were engaged in false financial accounting you might  end up in jail or not (like Poul Thorsen), but since it is only sick and dead infants it seems like there is no need to interfere.

John Stone is UK Editor for Age of Autism.

 

Comments

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John Stone

Hi Rachel

I am afraid you are just being silly. If the purpose is to assess the safety of the vaccines then excluding the inconvenient data is just the CDC playing its usual games, and there are two basic points: one is this suspiciously low number of reports from the US given how many are being entered from abroad, and the fact that they sidestep having to deal with x12 deaths from the Rotarix vaccine. In fact this is a very similar story to the Thompson one.

Rachel

@John Stone - the reports from outside the US were out of scope of the study, as the title states: "Intussusception after monovalent rotavirus vaccine-United States, Vaccine Adverse Event Reporting System (VAERS), 2008-2014."

You cannot reasonably accuse a paper of "losing 80% of cases" when those cases were not in scope in the first place.

John Stone

Thanks Jim - and it looks like exactly the same thing going on here. We have four times as many reports on a US database from abroad as from home, so we wonder what happened to all the US reports which are perhaps even below the low spontaneous reporting levels you might expect. Also it excludes all but one death for Rotarix (when there were twelve reported).

Jim Thompson

Dierdre Imus states: To start, there is a big difference between declaring something ‘safe’ and stating there is no ‘evidence of harm.’ See http://www.ageofautism.com/2015/10/deirdre-imus-rebuttal-to-timecom-regarding-chemicals-in-vaccines.html .

Of course this one of the main differences between fake science and real science. Real science makes a guess and then looks at all evidence that might support or refute the guess.

Fake science states a conclusion and then selects only evidence that might support the conclusion. When the selected evidence is observed they declare proven safety.

This way government agencies, without ethics or conscience, can promote corporations’ products with a “safe” label, even though it is based on fake science.

And this is where it got tricky for Dr. Frank Destafano and his colleagues at the Centers for Disease Control in their MMR study. Even when they weren’t looking for evidence of harm they found it. And they literally trash canned it. This is criminal fake science.


Congressman Posey, July 29, 2015, on the floor of the Unites States House of Representatives: “Dr. William Thompson, a senior scientist at the Centers for Disease Control and Prevention, worked with a whistleblower attorney to provide my office with documents related to a 2004 CDC study that examined the possibility of a relationship between the mumps, measles, and rubella vaccine and autism…
‘All the authors and I met and decided sometime between August and September 2002 not to report any race effects for the paper. Sometime soon after the meeting, where we decided to exclude reporting any race effects, the coauthors scheduled a meeting to destroy documents related to the study.
The remaining four coauthors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can.
However, because I assumed it was illegal and would violate both FOIA and DOJ requests,
I kept hard copies of all documents in my office, and I retained all associated computer files.
I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.’” See page H5602 at https://www.congress.gov/crec/2015/07/29/CREC-2015-07-29.pdf .


John Stone

I took this article down for 24 hours to consider the points made by "n davis" and "n davis is correct". I had overlooked the fact that the paper selects US cases only - that there are only a trickle of cases from the US against a relative flood from abroad - and this is basis of massive selection bias, particularly in relation to deaths. It also shows that the US reporting system while always vastly inadequate is wilting. Pharmaceutical companies are required by law to forward reports from abroad where they come to their attention: there is nothing in n davis's claim that these reports were unavailable to DeStefano - anyone interested in the safety of the vaccine to US children or any other would have considered all of the reports.

http://wonder.cdc.gov/wonder/help/vaers/VAERS%20Advisory%20Guide.htm

Denise Anderstrom Douglass

Frank DeStefano is a criminal and needs to be prosecuted. If that is slander they better sue me too. Of course, I'm just one of the little people, and you can't get money out of a stone. How's about you?

Gary Ogden

Thanks, John. It's bad enough that the Wall Street crooks, the torturers, and the Pharma execs never spend a day in jail, but DeStefano and his ilk deserve life sentences at hard labor for maiming and murdering babies and children. It was such a thrill to hear RFK, Jr. calling him out in Grant Park last Saturday.

n davis

@John Stone,

As I wrote earlier, when I searched the VAERS database this morning I obtained a readout in agreement with DeStefano's. Your post seems, therefore, to have something more to do with the different ways to access the database (via NVIC or directly through the VAERS site,) which are not under DeStefano's control. Perhaps you should address why the VAERS system, which DeStefano apparently accessed in the standard way, produces different results than those produced by the NVIC front end to that database.

n davis is correct

NVIC's version of VAERS includes foreign reports, which is where the 465 extra ones come from (as a search using the real thing will easily reveal).

However, the title of the paper is "Intussusception after monovalent rotavirus vaccine-United States, Vaccine Adverse Event Reporting System (VAERS), 2008-2014."

Benedetta

DeStefano - says after every other word -- "you know".

Well I don't know; but I sure have been finding out for the past 30 plus years.

Orange hmmmm the new black -- yes I agree CD; just in time for Halloweenie.

John Stone

Jim

I think people should stop hiding behind "the greater good" and start telling the truth. If the program is only sustainable by telling lies then we will have to do without program: indeed there could scarcely be a weaker case than for for rotavirus vaccine, (except for HPV, flu, Hep B for neonates etc etc)

John Stone

n davis

They said they had 112 reports of which they considered 4 unreliable. If you click on the link provided as of the time writing it will confirm the 565 reports reproduced in the photoshot. If they considered 457 reports to be unreliable they should have said.

Jim Thompson

John, hiding the deaths in a cover-up of data in a scientific report with more children expected to die-- how is this different, in any criminal case, than the following murders?


"The children were completely unsuspecting."

See http://www.auschwitz.dk/Bullenhuser.htm

n davis

I wonder what criteria DeStefano used for inclusion in his database. The paper states, "VAERS received 108 confirmed insusceptible reports after RV1."

When I searched the VAERS database this morning, I came up with 108 case reports of intussusception following RV1 in that time period. Among those cases were some apparent duplicate reports and some rather vague reports like this:

"This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception."

I don't understand why your results differ from Stefano's--and from mine. Perhaps the key is that DeStefano's article addresses only "confirmed" reports, even if those confirmed reports are vague.

CD

Orange is the new black. Really can't wait for these researchers to receive their just punishments for crimes against our children.

Linda1

The other part of this crime is the complete disregard for the (free) protection provided by human milk. How many of those estimated 15,000 hospitalizations would be prevented if infants were breastfed? Science suggests, most:

"Not only is the concentration of secretory antibodies (mainly IgA) in breast milk remarkably high (10–100-fold higher than in serum),[13] milk antibodies also possess a broad range of specificities, reflecting both maternal immunologic memory and antibodies directed towards pathogens that do not infect breast tissues, such as rotavirus.[14] Secretory antibodies in milk mirror maternal antigenic stimulation of mucosa-associated lymphoid tissue (MALT) both in the gut and the airways. Given the symbiosis between the breastfed infant and his/her mother during the first weeks of life, the microorganisms in the mother's environment are likely the same as those encountered by the infant. Intriguingly, milk composition changes (i.e., increase in the total number of white blood cells and higher TNF-α levels) have been documented in relation to active infection in the nursing infant.[15]

Mothers may thus be considered as immune 'factories', providing infants with antibodies that prevent, postpone or attenuate diseases caused by pathogens in their environment. In contrast to most therapeutics and immunizations, breast milk displays the unique potential to adapt itself to the requirements of the infant. Timely immune defenses are tapped from its constituents by immune regulation, modulation and immune acceleration to stimulate novel substances; these ad hoc modifications provide defense even in the face of evolving organisms.[15]"

http://www.medscape.com/viewarticle/814970

"Lactadherin is the 46-kDa glycoprotein of the human milk fat globule membrane, which is also known as PAS-6/7, indicating the two glycosylation variants on sodium dodecyl sulfate–polyacrylamide gel electrophoresis analysis.96 Human milk lactadherin binds specifically to rotavirus and inhibits its replication, thereby protecting human milk-fed infants against symptomatic rotavirus infection.97 Human lactadherin inhibits rotavirus infection of MA 104 and Caco-2 cells by direct interaction between rotavirus and the oligosaccharides of the lactadherin molecule.98"

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3725943/

Instead of making sure that every human infant is appropriately fed human milk, which should be a protected birthright, human milk is replaced at huge financial and human cost with pharmaceutical slop, vaccines, antibiotics, hospitalization, surgery and tragically, in some cases, a grave site.

Go RFK

What a creep!

Benedetta

You think of all the people that have been harmed by vaccines in the past -- all the gut trouble - all the diabetes, all the obesity, all the parkinsons --- the suffereing it has caused

He held back research -

I see my friend has her new grandie strapped in a car seat and has a caption below - off to see the peds for ther first round of vaccines.

You can't turn them for medical dogma - even under the threat of brain injury and death. Frank DeStefano has such power over common people's lives. He could have been a good man and followed the science and instead he held it back making us years behind where we should be.

Jail time I want him to have jail time so really bad. But he won't and life will sort of still go on.

John Stone

I need to update on the Indian court case which has not gone well - some might say scandalously - but just to mention something curious regarding DeStefano which came to my attention recently relating to Thompson's 2007 thimerosal paper "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years".

http://www.nejm.org/doi/full/10.1056/NEJMoa071434

First anomaly I note is that there are no author affiliations. DeStefano is in the last position which makes him senior author and it is also noted that he represents the Vaccine Safety Datalink Team. In a subsequent letter to the journal replying to Sallie Bernard he signs himself:

"Frank DeStefano, M.D., M.P.H. RTI International, Atlanta, GA 30341"

http://www.nejm.org/doi/full/10.1056/NEJMc072980

His address here is not the CDC but RTI International, a commercial sub-contractor to the CDC - so it looks like DeStefano is also an employee of an outfit that the CDC hires. I don't know what the ethics of this are and I don't know why he signs himself from RTI rather than CDC, but I point it out.

Bob Moffitt

Let's be clear here .. IF the growing allegations of CDC statistical research corruption and deception are eventually PROVEN .. Dr Frank DeStefano, the CDC's Director of Immunization Safety .. WILL justifiably be held accountable .. and .. deserving of PROSECUTION .. in a CRIMINAL COURT .. for CRIMES against innocent toddlers .. including FUTURE generations of children not yet born .. that he is ALLEGED to have participated in.

I cannot think of a single CRIME ever committed by a single individual in my 75 years .. that would even come close .. SHOULD THE FESTERING ALLEGATIONS ACCUSING DR DeStefano EVENTUALLY BE PROVEN IN A COURT OF LAW.

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