FDA ties pneumonia deaths to infant vaccine ~ MSNBC

[mzmolly]

MSNBC

WASHINGTON - GlaxoSmithKline Plc's Rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.

The review comes ahead of a Food and Drug Administration advisory meeting next Wednesday to consider approval of the oral vaccine to prevent the most common cause of severe diarrhea and dehydration among infants and young children in the world.

FDA staff said its analysis of 11 studies revealed that in the largest trial, there was a statistically significant increase in deaths related to pneumonia compared with placebo, documents posted on the FDA's Web site said.

That study, which enrolled about 63,000 children, also found an increase in convulsions in children given the drug, named Rotarix. Another study found an increased rate of bronchitis, compared with placebo.

[acmavm]

1. When will it dawn on people that everything we put in our bodies

is a toxin? Some toxins have beneficial effects such as vitamins and nutrients. Some have not so great results such as arsenic and many drugs. And people are just shoving shit into their bodies as fast as they can. Because someone tells them its good for them is good enough reason for some people to start taking or eating everything without thinking about it.

[Warpy]

2. Wow, what a way to look at the world

I suppose you'd prefer to be sealed in a glass container and fed pellets of absolutely sanitized nutrients washed down with distilled water.

One thing you can say about our bodies is that they're designed to handle a certain amount of environmental poison. We're designed that way so we can get the vitamins in potato skins, for instance, or metabolize the alcohol in fermented fruit.

The problem in the story above is one that often happens during clinical trials: a vaccine that worked on a group of healthy adult volunteers did not work on the target group of more fragile clients.

Don't forget that rotavirus also kills infants. A vaccine against it would have been a wonderful thing.

[mzmolly]

3. In the US it is very rare to die from rotavirus. Between 20 and 60 deaths

occur annually. This vaccine would perhaps help in third world countries, but not if we're trading rotavirus/dehydration for pneumonia and/or deadly convulsions?

Children are typically treated by replacing lost body fluids through drinking products that contain water with sugar and minerals. In severe cases requiring a visit to the emergency room or hospitalization, body fluids are replaced with fluids given directly to the child through the veins using an intravenous (I.V.) line.

[Warpy]

4. That's true, but it will help in the US, too

because there are a lot of parents out there who can't even afford the Pedialyte. Until this country straightens out the healthcare mess, expect to see an increase in preventable infant deaths.

A stable vaccine would have been a godsend to people who lack the means to get the baby clean water and electrolytes, let alone a trip to a hospital.

[mzmolly]

6. Gatorade works for dehydration as well.

However, it is interesting to me that one can transport a child to a clinic for a vaccine, but not in the event of an emergency? And, in spite of the barriers you mention, rotavirus still only claims 20-60 lives in the US annually. The flu claims over 30,000. I don't think a mass vaccination program for this illness would be as harmless? But, you can bet when they find a vaccine they can market, we'll all be "afraid" of rotavirus. We'll hear about the half a million deaths "world wide" yet the word "world wide" will be omitted from any propaganda pushing the sale of the vaccine.

However, I don't feel that the vaccine is a done deal. They had another failed vaccine for rotavirus as well yet the pursuit continues. I expect as long as there is a "market" they'll find a way to produce a vaccine?

[acmavm]

5. Yeah, we can handle a certain amount. Not as much as people are shoving

down their throats. And my way of looking at the world is called the scientific approach. You should try it.

Yeah it would be nice to have a vaccine for rotavirus. It would be nice to have a vaccine for the common cold. But we don't. And we don't have anyone policing the phama companies. They are policing themselves. But people just keep on taking the Prozaz and whatever thinking if it comes in a prescription bottle, it's GOTTA be good.

Apparently the only people who aren't guzzling meds are the ones who really need them. To keep them from shooting up shopping malls or college campuses. Otherwise just medicate away. For everything from a twitchy leg to a limp penis.

And hell, the over the counter shit is a multi-billion dollar a year industry. But when the latest drug for losing weight or keeping you awake also is found to cause serious physiological injury well then, it's LAWYER TIME. Money will make it better. And you shouldn't be held responsible, why, you were just an innocent victim looking for the cheap and easy way to make yourself feel or look better.

[Warpy]

8. A rant and an ad hominem. Very nice.

Bye.

[acmavm]

23. As opposed to an inablility to reason and face facts, it ain't bad.

[cosmik debris]

7. That's just ridiculous!

Did you even bother to read past the headline?

There was no evidence presented about causation, only association.

I'm sorry if you are not smart enough to see the difference, but I'm sure a little education would help.

You also managed to overlook any statistically significant drop in the incidence of Rotavirus.

I don't understand why you try so hard to scare people based on such shaky information?

[Celebration]

9. huh?

All the OP did was quote the headline and the article................what's so wrong with that?

[cosmik debris]

10. That bold print didn't appear by itself. n/t

[mzmolly]

13. Ahhh, so now I'm guilty of 'BOLDING'

:eyes:

Are you saying that there is no relationship between the vaccine and the statistically significant increase in pneumonia/convulsions?

http://www.reutershealth.com/archive/2008/02/15/eline/links/20080215elin026.html

Oh and this is such a pity - Bernstein Research analyst Tim Anderson said safety issues could mar his current forecasts for the drug of reaching sales of $1.3 billion by 2012.

[cosmik debris]

16. What I'm saying is that you are a fear monger.

You look for things to incite fear and you post them in the Health Scare Forum.

You emphasize the fear while passing over the rational.

Your reputation precedes you.

[mzmolly]

17. Well then, you can add the FDA and MSNBC to your list of "fear mongers".

Again, the fear mongers among us are those who suggest that we're all doomed to die if every person in the US doesn't get every vaccine ever produced.

Sorry to frighten you with by "bolding" and all. But, thanks for kicking my thread. :hi:

[mzmolly]

24. Yes, I'm a "bolder" and a *gasp* "fear monger" who dares to provide info from the FDA press release,

regarding this particular vaccine.

FYI - Vaccine questions/concerns should never be posted and/or discussed as they may cause mass hysteria and everyone will stop vaccinating and we'll all die of wretched disease! :sarcasm: ;)

:hi:

[mzmolly]

12. Can you share which claim I made regarding "evidence of causation"?

It is you that needs to "read" apparently?

I'm sharing information, feel free to disregard this as "coincidence" again.

[cosmik debris]

14. You are not just sharing information.

You are spinning information with the obvious intent to scare and mislead, thus the passages you put in bold type.

You ignore the reasonable facts in the article (that claim only an association) in favor of the inflammatory speculation.

Your reputation as a fear monger precedes you.

[mzmolly]

15. I would suggest the fear mongers are those trying to convince us

that we need to expose all of our children to the potential risks associated with this vaccine in order to prevent a possible 20-60 deaths in the US annually?

Your reputation as a drug company advocate precedes you.

[cosmik debris]

18. Ah! the copy cat thread. pathetic!

A simple search turns up many post by you inciting fear.

Can you produce any post by me where I advocated for a drug company?

[mzmolly]

19. Again, I'm sorry if my posts "frighten" you.

And, your attempt at advocacy, while weak, can be found in your repetitious, "you're a fear monger!!!" assertions. Apparently "attacking the messenger" is the best you can do? It's par for course with the drug company defense cult.

[cosmik debris]

20. I'm not so easily frightened as you

I read the entire article. I didn't just read the scary parts.

[mzmolly]

21. Perhaps you can share the "non scary" parts?

Feel free to bold if you like.

[chicagomd]

11. Guess the makers of Rotateq

are safe for a bit longer. Back to the drawing board for GSK.

[Celebration]

22. actually, I think this was approved anyway

With one person dissenting for safety reasons.

[mzmolly]

25. Oh my, look at this:

http://www.smartmoney.com/news/on/index.cfm?story=ON-20080215-000711-1029

UPDATE: FDA: Rotavirus Vaccine Effective, Appears Safe

GlaxoSmithKline, in documents also posted to the FDA's Web site, said it believed the risk-benefit ratio for the vaccine is "overall favorable." The company noted that rotavirus causes about 114 million cases of gastroenteritis annually in children age 5 and younger and about 600,000 deaths, worldwide.

Why don't they mention in the sales pitch that only 20-60 deaths occur in the US annually?

If this vaccine is mandated and can "cause" pneumonia in some, will the death toll from the jab exceed the 20-60 we are attempting to prevent?

I'd like to know when a vaccine "appears un-safe" given the criteria for appearing "safe" apparently includes overlooking an increased incidence of potentially deadly pneumonia?

[cosmik debris]

26. The sky is falling! The sky is falling!

[mzmolly]

27. An apt comparison of

your position on the dangers of posting a link to the MSNBC/FDA press release, thanks.

[cosmik debris]

28. Oh, you're just too sensitive, you poor persecuted thing

Shovels not good enough, here ya go.

[mzmolly]

29. I don't feel persecuted.

I feel vindicated by your fear of information though.

Have a nice evening, I'm bored with your nonsense. :hi:

[cosmik debris]

30. Why so defensive?

You don't like being the butt of jokes?

[Name removed]

31. Deleted message

Message removed by moderator. Click here to review the message board rules.

[mzmolly]

32. Ah, another ignorant abusive censor rears HIS ugly head. I'd say attempting to

quell this important info regarding pneumonia and the vaccine is "anti woman/children".

In your world possibly trading pneumonia and convulsions for diarrhea, is a good deal for women/children?

I suggest your rant about my being anti-woman/child is due to your elitist attitude that "men" like yourself do not need to be vaccinated?

[Name removed]

34. Deleted message

Message removed by moderator. Click here to review the message board rules.

[mzmolly]

39. I posted information from the FDA via the MSNBC website. Again, your attempt to censor

with abusive right wing tactics are noted, however they remain futile.

My stand on the HPV vaccine actually mirrored the scientist who developed the vaccine. But, go ahead and pretend you know something.

[mzmolly]

33. If there were a joke to be found, I might be amused.

However, there is nothing funny about your attempt to censor this information.

[xchrom]

35. you are the joke -- and the punchline for those able to read. nt.

[mzmolly]

38. Wow, that is some profound shit.

:eyes:

[xchrom]

45. people like you need it to be simple -- really, really simple.

:eyes:

[mzmolly]

46. Welcome to ignore.

In spite of your obvious ignorance, I've been "listening" to your nonsense for far too long.

Cheers.

[cosmik debris]

36. Ooooo! censorship! That's part of the joke.

You have every right to post whatever you like. I certainly can't censor your posts. That type of accusation is just another symptom of your paranoid fear mongering. Any one who laughs at you must be a censor in your mind.

And you can't even see how funny that is? Watching your reaction to people who contradict you is freakin' hilarious.

[mzmolly]

37. Your continued verbal abuse and insults is an attempt at censorship.

One, that only emboldens me, however.

[cosmik debris]

40. Yes, that's the kind of over reaction I was talking about

Clearly none of your posts have been censored, edited, redacted, or modified in any way. But your repeated howls of censorship show just how paranoid and obsessed you are.

You made a laughing stock of yourself and discredited your own posts.

Congratulations. You made my day!

[mzmolly]

41. Apparently you don't understand the term "attempt at censorship"?

You and your friends wish to bully me into compliance with verbal insults. But it will not work. I will continue to post information such as this even if the truth is offensive to you and your ilk.

[cosmik debris]

42. And you don't understand the difference

between offensive and comical. You haven't offended me in any way. You have merely amused me.

And until you learn the difference between contradiction and censorship, you will continue to amuse me.

That chip on your shoulder must really weigh you down.

[mzmolly]

43. You haven't actually contradicted anything.

But, that's your problem.

I'm done with you, you are the one person on my ignore list. And, it's not because you have anything compelling to say, it's because you are a person of many words and very little thought. I don't mind actual conflicting opinion, but I do mind continued nonsense.

As the old saying goes ... when you wrestle with a pig, you both get dirty and the pig likes it.

:hi:

[cosmik debris]

44. Pobrecita, que lastima!

It must suck being you.