RotaTeck, New Vaccine for RotaVirus

[Ted]

Our baby is 2 months old and our doctor recomended that we be included in
the testing of the new rotavirus called rotatech (I think that is how it is
spelled). I know they pulled the previous rotashield. Does anyone have any
input on if we should do it? The benifits seem pretty good.

TIA

[D. C. Sessions]

In >, Ted wrote:

> Our baby is 2 months old and our doctor recomended that we be included in
> the testing of the new rotavirus called rotatech (I think that is how it is
> spelled). I know they pulled the previous rotashield. Does anyone have any
> input on if we should do it? The benifits seem pretty good.

Actually, even the previous one was a good deal.
The differential risk was quite a bit lower than
the risk from the virus itself, but we're pretty
touchy about that kind of thing.

If your paed thinks it's a good idea, ask why and
what the prior testing showed.

--
| "Really, I'm not out to destroy Microsoft. That will just be a |
| completely unintentional side effect. " -- Linus Torvalds |
+--------------- D. C. Sessions > ----------+

[Roger Schlafly]

"Ted" > wrote
> I know they pulled the previous rotashield. Does anyone have any
> input on if we should do it? The benefits seem pretty good.

What benefits? Rotavirus just causes some diarrhea, and is
usually not a big deal. The previous vaccine was associated
with some serious ethical lapses, and serious complications.
Do you trust them to get it right this time? I wouldn't.

[john]

"Ted" > wrote in message >...
> Our baby is 2 months old and our doctor recomended that we be included in
> the testing of the new rotavirus called rotatech (I think that is how it is
> spelled). I know they pulled the previous rotashield. Does anyone have any
> input on if we should do it? The benifits seem pretty good.
>
> TIA

Oh yeah, ask him if he gets a kickback for supplying kids for trials,
and if his kids are in the trial also.

john

[CBI]

"Roger Schlafly" > wrote in message >...
> "Ted" > wrote
> > I know they pulled the previous rotashield. Does anyone have any
> > input on if we should do it? The benefits seem pretty good.
>
> What benefits? Rotavirus just causes some diarrhea, and is
> usually not a big deal. The previous vaccine was associated
> with some serious ethical lapses, and serious complications.
> Do you trust them to get it right this time? I wouldn't.

I don't have the exact figures in front of me right now but I have
posted them a few times and a google search should pull them up. if
memeory serves....

Basically, based on the available data, the old vaccine (Rotashield)
would have been expected to prevent several hundred thousand cases of
disease per year, several hundred hospitalizations per year, and about
16 deaths per year from rotavirus. I would say this is all a little
more serious than "some diarrhea." Roger has seen these facts before
but he refuses to acknowledge them because they are a bit awkward for
his anti-medicine world view (really more of an "everyone is dumber
than I am" world view).

The down side was an increased incidence of bowel obstruction that
could lead to surgery. In the end this complication would have been
expected to kill between 0-1 kids per year.

About one in three cases of obstruction that occured in the post
vaccination period would have been due to the vaccine but the product
would have surely been blamed for all three. The company decided that
the liability issues were too high and so voluntarily pulled it off
the market despite the fact that doing so is probably resulting
several hundred hospitalizations and 15 deaths per year. In our system
you pay for the things that you might have caused but don't get
rewarded for the lives you might have saved - or even did save!

I don't know anything about this new vaccine so I can't comment
specifically on it. But, if the old one was still around I would have
gladly given it to my kids even knowing all that we know now.

--
CBI, MD

[PF Riley]

On 3 Oct 2003 03:39:13 -0700, (john) wrote:

>"Ted" > wrote in message >...
>> Our baby is 2 months old and our doctor recomended that we be included in
>> the testing of the new rotavirus called rotatech (I think that is how it is
>> spelled). I know they pulled the previous rotashield. Does anyone have any
>> input on if we should do it? The benifits seem pretty good.
>
>Oh yeah, ask him if he gets a kickback for supplying kids for trials,
>and if his kids are in the trial also.

That second question is a good one. My clinic is participating in
pre-licensure trials of a new conjugate vaccine for meningococcus type
C. Almost all parents sign up for it without hesitation when I tell
them I had my daughter get it.

Oh, and no one gets any money for it. Just a free vaccine against a
terrible disease.

PF

[Jeff]

"PF Riley" > wrote in message
...
> On Fri, 03 Oct 2003 19:27:57 GMT, "Marko Proberto"
> > wrote:
> >
> >"Roger Schlafly" > wrote in message
> ...
> >> "Ted" > wrote
> >> > I know they pulled the previous rotashield. Does anyone have any
> >> > input on if we should do it? The benefits seem pretty good.
> >>
> >> What benefits? Rotavirus just causes some diarrhea, and is
> >> usually not a big deal. The previous vaccine was associated
> >> with some serious ethical lapses, and serious complications.
> >> Do you trust them to get it right this time? I wouldn't.
> >
> >"Some diarrhea"??? Are you referring to your posts?
>
> Roger, as usual, is not ashamed of how stupid he is. Apparently he's
> never worked in a typical pediatric ward during the winter,
> calculating fluid and electrolyte replacement therapy for all the kids
> with just "some diarrhea."

Or worked in a pediatric ICU or pediatric emergency room. Kids with
diarrhea and vomiting can go from very healthy, normal kids to very sick in
just hours from diarrhea and vomiting. By very sick, I don't mean that they
have lots of nasty stuff leaving their digestive tracts. Rather, they have s
rapid pulse, extremely pale skin, low blood pressure and poor perfusion
(meaning that the blood is not moving through vital organs well). Unless
they get rehydrated with the right solution, they won't live. And if the
illness strikes in the middle of the night or in the middle of a snow-storm,
the parents might not be able to get the child to help.

Jeff

> PF

[CBI]

"CBI" > wrote in message
om...
> "Roger Schlafly" > wrote in message
>...
> > "Ted" > wrote
> > > I know they pulled the previous rotashield. Does anyone have any
> > > input on if we should do it? The benefits seem pretty good.
> >
> > What benefits? Rotavirus just causes some diarrhea, and is
> > usually not a big deal. The previous vaccine was associated
> > with some serious ethical lapses, and serious complications.
> > Do you trust them to get it right this time? I wouldn't.
>
> I don't have the exact figures in front of me right now but I have
> posted them a few times and a google search should pull them up. if
> memeory serves....

Here are the exact figures cut and pasted from a previous post. The article
we were discussing appeared in the Feb 22, 2001 NEJM.


> The NEJM study was based on data collected after licensure. It was part of
> the post licensure surveillance that was recommended when the vaccine was
> approved. It was a small study looking at about 400 cases each in two
> groups where they did both a case-control and a case-series analysis. In
the
> case control analysis they found a 21.7x risk (9.6-48.9) and in the
> case-series analysis they found a 29.4x risk (16.1-53.6). I notice the
> Schafly's like to quote the higher number. The analysis of data was
confined
> to the 3-14 day period after the first vaccination, after which the rate
of
> intussusception dropped to the baseline level.
>
> According to the authors' estimates a nationwide program of vaccination
> would result in between 361 and 732 extra cases of inussusception above
the
> background rate of 1291 cases per year. In this study about 40-50% of the
> cases required surgery and none of the children with vaccine associated
> intussusception died (one with non-vaccine associated intussusception
died).
>
> Compare this to 3.5 million cases of rotavirus annually leading to 500,000
> office visits and 50,000 hospitalizations and 20 deaths. The vaccine was
> about 80% effective meaning those numbers would likely drop to 700,000
> cases, 100,000 office visits, 10,000 hospitalizations, and 4 deaths. If
> there was a herd immunity effect the reductions would be even greater.
>
> This goes back to my statement about it not being demonstrated that the
> vaccine was dangerous. Yes, it would cause about 500 extra
intussusceptions
> per year leading to about 200-250 surgeries, and 1 or zero deaths while
> preventing over 2.8 million cases, 400,000 office visits, 40,000
> hospitalizations, and 16 deaths. Certainly, efforts to make a safer
vaccine
> should be continued. Looking at these numbers makes me wonder if I can dig
> up some old doses to give to my eight month old. Chances are, it would
help
> her avoid the hospital and have a better chance of survival.
>

[PF Riley]

On Sat, 4 Oct 2003 09:38:20 -0400, "Jeff" >
wrote:
>
>Or worked in a pediatric ICU or pediatric emergency room. Kids with
>diarrhea and vomiting can go from very healthy, normal kids to very sick in
>just hours from diarrhea and vomiting. By very sick, I don't mean that they
>have lots of nasty stuff leaving their digestive tracts. Rather, they have s
>rapid pulse, extremely pale skin, low blood pressure and poor perfusion
>(meaning that the blood is not moving through vital organs well). Unless
>they get rehydrated with the right solution, they won't live. And if the
>illness strikes in the middle of the night or in the middle of a snow-storm,
>the parents might not be able to get the child to help.

It was actually because of rotavirus that I got to see uremic frost.
This was probably a once-in-a-lifetime occurrence for me as,
obviously, thanks to modern nephrology and dialysis, uremic frost
isn't very common. The infant had rapidly become so dehydrated in just
one day that he developed prerenal azotemia (acute renal failure),
complete anuria, and his BUN climbed over 200. As I was admitting him
to ICU, I noted fine crystals all over his skin. A nurse saved his
life by getting a 22 G catheter in his vein (he had, surprisingly,
arrived in ICU from ER without intravenous access because his
intravascular volume was so low his veins were all collapsed) and
after a few IV boluses of normal saline the frost disappeared and
urine output returned. Fortunately plans for dialysis were canceled as
it became apparent the renal failure was purely due to dehydration.

How's that for just some diarrhea?

PF

[Tsu Dho Nimh]

"CBI" > wrote:

>Here are the exact figures cut and pasted from a previous post. The article
>we were discussing appeared in the Feb 22, 2001 NEJM.

>> The analysis of data was confined
>> to the 3-14 day period after the first vaccination, after which the rate
>of
>> intussusception dropped to the baseline level.

Wasn't there actually a decreased risk of intussusception after
they left that window? I vaguely recall seeing a study that
indicated the vaccinated group had a lower incidence over the
whole period, just with the immediate post-vaccine 'blip".



Tsu Dho Nimh

--
When businesses invoke the "protection of consumers," it's a lot like
politicians invoking morality and children - grab your wallet and/or
your kid and run for your life.

[CBI]

"Tsu Dho Nimh" > wrote in message
...
> "CBI" > wrote:
>
> >Here are the exact figures cut and pasted from a previous post. The
article
> >we were discussing appeared in the Feb 22, 2001 NEJM.
>
> >> The analysis of data was confined
> >> to the 3-14 day period after the first vaccination, after which the
rate
> >of
> >> intussusception dropped to the baseline level.
>
> Wasn't there actually a decreased risk of intussusception after
> they left that window? I vaguely recall seeing a study that
> indicated the vaccinated group had a lower incidence over the
> whole period, just with the immediate post-vaccine 'blip".

Not that I recall but I would have to pull the study out again and look at
it and it certainly could have been mentioned in another one that I have not
seen.

--
CBI, MD

[Tsu Dho Nimh]

"CBI" > wrote:


>Not that I recall but I would have to pull the study out again and look at
>it and it certainly could have been mentioned in another one that I have not
>seen.

It was a followup, after the withdrawal. Someone went back
through the public health records and noitced the blip increase
and a longer-term decrease.



Tsu Dho Nimh

--
When businesses invoke the "protection of consumers," it's a lot like
politicians invoking morality and children - grab your wallet and/or
your kid and run for your life.