GSK Rotavirus Vaccine Study Loses 80% Of Cases And 18 Deaths


We 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.

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).

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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.

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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.

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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.