SteveD, I actually agree with your original assessment that clinical testing is superior to passive surveillance - which is why I picked at it. Passive surveillance sucks, plain and simple. So it’d be interesting to ask why passive surveillance outperformed clinical testing for RotaShield?

Perhaps it’s because clinical tests are primarily marketing tools: they are hoops the vaccine manufacturer has to jump through in order to market their product. Of course the advantages are immense: the vaccine manufacturer gets third party approval (the FDA) and they get a guaranteed market (addition to the vaccine schedule).

I would contend that the overwhelming financial imperative to pass clinical testing corrupts the vaccine manufacturer’s ability to produce reliable results. Merck’s goal during clinical testing is not to find out whether the vaccine is safe, their goal is to report that the vaccine is safe (so the product can get on the market and start making money for them).

Exclusion criteria in clinical testing are designed to minimize the potential for catching adverse events. Why exclude children from clinical testing who are intended to get the vaccine once it is licensed? Because if they’re included, Merck lowers its chances of getting the results necessary for product approval.

Every decision Merck makes is financial: if they can make money from a safe product that prevents disease – great! But regardless, they intend to make money, and if that means the product isn’t as safe or as effective as advertised, oh well. Sure that’s just my opinion, no point in arguing about it I suppose.

So this time around there’s a bunch of additional passive surveillance set up to catch problems with the new rotavirus vaccine. Unfortunately we shouldn’t have to rely on parents bringing their damaged kids into the hospital in order to discover vaccine-associated adverse events. Clinical testing is superior to passive surveillance. The only drawback is that you have to actually do it right. And the fact that the vastly inferior passive surveillance outperformed clinical testing in finding the association between RotaShield and intussusception tells us that clinical testing is not being done right.

Steve D

So why have the CDC and FDA not acted on the approximately 60 reported associated deaths on VAERS in the past year? How many would it take to have "triggered any alarms"?

Steve D,

My link does work. It's an Acrobat file, so you have to download it to read it.

As for the worldwide impact of the vaccine, it appears that you're suggesting that the CDC and the various state governments that have added RotaTeq to their vaccination schedules have done so, at least in part, to stop the spread of rotavirus from American children to African children. This is beyond ludicrous. Kim's original post concerns the cost-effectiveness of RotaTeq in the US, where (as bensmyson noted) clean water and nutrition are not the overwhelming problems that they are in developing nations, where the vast majority of rotavirus deaths occur. Is it really likely that children in developing nations are catching rotavirus from American schoolchildren? (Just imagine the government in a developing nation hauling out the old saw that "death is just a plane ride away"...)

Steve D

I don't apologise for expressing expressing outrage at negligence. You are also trying to have your cake and eat it. The deficiencies of a passive recording system, and the fact that even then the asociated death toll is more than 4 times higher than for the disease (and presumably it isn't even mandated for all states), makes this association deeply troubling. If you are simply going to disregard the information because it doesn't meet your preconceived notions about the safety of the medicine then your views can scarcely be respected.

You then dodge by referring me to the global impact of the illness, and we move into quasi racist territory because you seem to be arguing that what might not be good enough for US children might be simply great for the children of the developing world. Indeed, I would point out that pre-marketing trials were carried out on only on "healthy" infants (none of whom were given oral polio vaccine concurrently) admittedly in many countries, but then of course rolled out for everybody. We haven't got the protocol for what constituted a healthy infant but check out this post by Hilary Butler which gives such a protocol for testing a small-pox vaccine ('Why were in this position in the first place') with an absolutely mind-boggling list of exclusions:

http://www.bmj.com/cgi/eletters/331/7525/1148#121832

So, in fact no one has the remotest clue what the risk-benefit ratio is globally and for all children, and frankly the original trials were worthless.

The Offit does not seem to realize that diarrhea is the body's natural defense to get rid of bacteria that it does not like. This vaccine is another example of messing up a person's immune system. Nobody can count the cost of THAT.

http://kerboblog.blogspot.com/2009/02/help-wipe-out-offits-disease.html

Theresa -
Unfortunately, your link does not work. Regardless, I agree that clinical safety trials are not perfect, but the relative strength as compared to VAERS data creates an apples-to-oranges comparison. For example, in VAERS reports there are utterly zero controls on the data.

John -
You are misrepresenting my position. I fully support post-marketing surveillance and believe in its efficacy to do that which it was designed to do. Both VAERS and the vaccine safety datalink are important aspects of this safety system.
Your last statement about "dead infants have to be added to the heap" is a striking example of ignoring the reality of the situation and appealing to emotion. But let's play your game and discuss infant mortality.
From http://www.cdc.gov/ncidod/EID/vol9no5/02-0562.htm
"Each year, rotavirus causes approximately 111 million episodes of gastroenteritis requiring only home care, 25 million clinic visits, 2 million hospitalizations, and 352,000–592,000 deaths (median, 440,000 deaths) in children <5 years of age."
But perhaps you aren't concerned about the potential positive worldwide impact of this particular vaccine?

SteveD,
The problem with the clinical trials is that they generally exclude the very kinds of infants that might be most susceptible to vaccine injury -- premature or low birthweight babies, those with underlying health issues, comorbid conditions or family histories of autoimmune disorders, etc.. It's all well and good to test the vaccine on 70000 of the healthiest babies, but that does nothing to predict adverse events in the real world.

Steve D's definition of "safety" differs from Webster's Dictionary... and reality.

When talking about rotavirus, you don't have to look very far to find confirmation of the failure of clinical testing: there was a rotavirus vaccine before this one. It was associated with intussusception and death.
Clinical trials did not catch the problem.
Post-marketing surveillance did.

Steve D, what's unreliable about VAERS data is that vaccine adverse events are (as John Stone noted) vastly underreported to VAERS. Clinical trial data have never really impressed me as reliable, particularly after reading Bloomberg's report, Big Pharma's Shameful Secret (http://www.bloomberg.com/specialreport/pharma.pdf).

I'm waiting for the cost-effectiveness analysis of the varicella vaccine. The CDC's own VIS indicates that only 100 deaths per year were associated with varicella prior to the introduction of the vaccine--and how much do we spend (through insurers and Medicaid) on pumping Varivax et al into kids every year?

I am actually quite surprised to see this article posted on Age of Autism. Normally this site is so critical of Dr. Offit, but this seems to be a simple question posed by the editor and supported by a published study of whether the Rotavirus vaccine is ultimately cost effective.
I guess what surprises me is that this site would post information that supports the position that Dr. Offit's rotavirus vaccine is:
a) efficacious, and
b) safe (despite Mr. Stone's protestations)

Mr. Stone is comparing VAERS data to the clinical trials results referenced in the study itself:
"Large clinical trials with 60000 to 70000 children have demonstrated these vaccines to be highly efficacious and without evidence of vaccine-associated intussusception or other serious adverse events.3,4"
Clinical trial data are far more reliable than VAERS data for obvious reasons.

The argument for cost effectiveness of Rotateq relates to its potential for improving health and saving lives. If, however, it costs lives the argument lapses and Dr Offit did well to sell his stake when he did.

The study, which was funded and conducted by the CDC can be read in full here:

http://pediatrics.aappublications.org/cgi/content/full/119/4/684

I am not sure how they can waive through all these deaths without suspending its use and calling an urgent review. The longer they leave it the more compromised they will be.

Perhaps Dan from Texas would like to give his explanation.

The conclusion is inconsistent: "unlikely [to be] cost saving... Nonetheless, rotavirus vaccination may still be considered a cost effective intervention." HUH?

I saw Paul Offit speak at the AAP convention in DC a few years about about the meningococcal vaccine. Even he couldn't justify the "cost per life saved" analysis. "Nevertheless, it may still be cost effective" I guess.

Okay, Dan, how many vaccine reactions do they factor in? Unless the number is accurate...

Maybe they will charge Offit with negligent homicide for inventing a vaccine that caused death. Why not, Law & Order ran a storyline about a women charged in the death of a child after her unvaccinated kid gave the dead child the measels. Anyone else witness that load of dung? NBC must have secured their drug ads for at least another year with this gem.