The Toxic Myth

[chicagomd]

For you lurkers in here who get to experience the best of DU's own anti-vaccination crusaders, here is a great blog article that will put some things in perspective and provide you with some history to the "debate".

http://www.sciencebasedmedicine.org/?p=9

[xchrom]

1. recommend

[trotsky]

2. One of the best articles I've read on the topic.

Condenses everything into a very readable and understandable piece.

[cosmik debris]

3. If facts made any difference the debate would be over K & R

But facts have never been able to trump superstition. So we will fight this battle over and over.

[xchrom]

5. what bothers me is that DU becomes a place

that passes on dangerous misinformation as fact.

speech is one thing -- helping people to make themselves and others sick with misinformation is another.

[Kitty Herder]

4. K & R

[varkam]

6. K&R

That's an excellent article. Thank you for posting it.

[Warpy]

7. Although I doubt the antivax crowd will understand any of this

article any better than the technobabble they regularly post (and which is very nicely debunked in this article), I give you kudos for a great try.

The bottom line is that the usual childhood diseases we now vaccinate our kids against weren't just nuisances, they were killers. Even measles was much more dangerous than the worst reactions from the vaccine.

Everything in medicine is decided on a risk vs. benefit basis. Those of us who are old enough to remember polio epidemics and kids in braces in our schools and in iron lungs in the hospitals know what the benefits are. The risk of vaccination is negligible compared to this.

Shame on the antivaxers.

[xchrom]

8. kick

[Celebration]

9. Perfect example

Of what the pro vaccination forces should do in response to the anti vaccine YouTube videos, etc. They should win the argument in the marketplace of ideas. Most certainly there is a lot of unfounded speculation by the anti vaccination forces, and this highlights that speculation. And some of it is really truly bizarre.

I liked reading the responses from people too, including one person on how low nitric oxide, from any reason, could lead to autoimmunity. I found that fascinating.

Here is the most disturbing anti vaccine You Tube video--

http://www.youtube.com/watch?v=yeIjiGRhj20

Let's see--watch until you get to the "joke" about how the USA would win the Olympics against the Russians. Why? The vaccines were being tested in Russia and the Russians would all be getting cancer. Haha, funny.

Let's say this historical information doesn't inspire a lot of confidence in people. You know, as in international politics, sometimes there *is* blowback. And it isn't as if I am exactly trusting of Merck to give us negative information on any of their drugs that they could just as easily hide.

[GoneOffShore]

10. Has our favorite anti vaxxer seen this yet?

Will he read it?

Will his head explode?

We live in hope.

[DCKit]

11. I completely agree with the concept of vaccination...

but American drug companies have gotten a free pass and unflinching government support for far too long. When decisions about what drugs to market are made by accountants who weigh potential profit vs. financial risk from lawsuits than scientists working to develop treatments and cures, the public suffers. The bean counters have formulas for this, and it's the standard across American industry. Car manufacturers, for example, are notorious for applying these formulas in order to save pennies on every component of every vehicle they build.

The World Health Organization (WHO) purchases few, if any, American made vaccines because the American manufacturers do not meet their production and purity standards, not because the prices are higher than those from European and Indian companies. The U.S. sets standards too low because the FDA has been allowed to become a tool of American corporations and is staffed by a revolving roster of industry insiders.

We could argue the point for days, but it's one thing to inject a weakened virus or partial proteins to stimulate an immune response to disease and quite another to knowingly introduce foreign matter that will result in poisoning or unintended allergic reactions - the flu vaccine, contaminated with egg and chicken proteins is a prime example.

You want "safe" vaccines? Go to Central or South America.

[chicagomd]

12. There is no point to argue, with you at least,

because you start off with a statement that ends the argument before it begins: The drug companies are evil, they only think of profit, therefore the vaccines in this country are dangerous and should not be used.

Why don't you read the article and its citations before you post? There is no poisoning, the flu vaccine is not "contaminated" with egg or anything else.

Your post really highlights the issue with the anti-vaccine crowd. You have made up your mind before even looking at the evidence presenting to you, so you respond with unsubstantiated statements and logical fallacy.

[lizerdbits]

13. What specific standards are lacking?

What about WHO standards is superior? What makes the vaccines in Central and South America safer?

The flu vaccine isn't "contaminated" with egg proteins. It's GROWN in embryonated chicken eggs. You are always asked about egg allergies before getting the shot for that reason. That's how you get the virus titers of 10^9 or so. Do you have a better way? I'd love to hear it since it doesn't grow in cell culture that well (at least in MDCK cells which is predominantly what's been used in the past).

[TZ]

14. No you have it exactly opposite

Most vaccines (even by US based companies) are made OVERSEAS because the restrictions in Europe (and India and China) are LESS STRINGENT. Therefore its less expensive. You might want to look up GLP,GMP, GCP on the FDA website and see what that entails. 10 years of toxicology, potency studies,safety studies, surprise inspections, meticulous data keeping etc. WHO actually does a lot of work with US companies INCLUDING Merck. How do I know? I worked in a vaccine research group at NIH that collaborated with both NIH and WHO.
Idiot.

[DCKit]

15. Thanks so much for your considered replies. You've changed my mind about everything.

Bwahahahahahaha!!!! Yet another rabidly third-rail issue to ignore in the future. Really, we buy inferior vaccines from overseas and give them to our kids because there's less regulation? You make a statement like that, then call me an idiot? What are you saying about our government and the drug companies by making that claim?

Since everything I know about drug companies, flawed/rigged drug studies, drug and drug company scandals, vaccines and the hidden, U.S. domestic presence and ownership of India's Serum Institute and the (French) Pasteur Institute is clearly incorrect, there's no reason for me to ever post on these subjects again.

Guess I should simply be happy with the fact that the gubmint is protecting U.S. from those evil, affordable Canadian drugs and socialized medicine and leave it at that. But I won't. The entertainment value of your arguments is worth a day's confinement in GD-P.

Thanks for the laugh.

[TZ]

18. Why do you think these vaccines are "inferior"

What are your creds? Have you actually worked in industry and seen it?
I have, I have also been through an FDA inspection. If there is ANYONE on this board that knows more about clinical trials and drug studies than I do, I would be shocked.
The vaccines we get from overseas AREN'T inferior, they are just cheaper in manufacture (which by the way is VERY EXPENSIVE)
You sir are a moron who has read a few stories on Google and decided you are the expert. You've nicely either ignored or misunderstood(and I think its misunderstanding, your lack of intelligence is quite clear) what we said.
Also WHAT THE FUCK does vaccine manufacturing have to do with cheap Canadian drugs.
You win the coveted dunce-of-the-day-award!!:dunce: :dunce: :dunce: :dunce:
On edit: anything manufactured overseas for sale here HAVE to comply with FDA standards, which doofus, are much more stringent than your itty bitty tinfoil hat squeezed mind can comprehend.

[DCKit]

19. When you're wrong, you're very wrong.

And enough with the personal attacks and juvenile name-calling. This isn't FR, in case you hadn't noticed. Please take your FDA approved happy pills and wait two hours before posting.

From the authors bio at:
http://www.sciencebasedmedicine.org/?author=8

'David H. Gorski, MD, PhD ... An NIH-funded investigator...." was all I needed before the alarm bells went off. The medical equivalent of Dick & Dumbya's climate scientists? Who knows, but I'm beyond cynical these days.

The too-tight tin-foil hat went in the trash several years ago when ongoing revelations about the current administration convinced me that consumer-grade foil was worthless. There is nothing they won't, or haven't done, to benefit the corporations that put them in power and, because WE KNOW they will alter, doctor or create data that supports any position they desire, I look at any study or article with sweeping declarations on either side of an argument with more than a little skepticism, especially those sourced from government agencies, studies and people funded by them. Competently written propaganda is still propaganda, even if it has lots of really big scientifically appropriate words in all the right places.

From: http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/index.html

Following is THE WHO list of approved vaccines and manufacturers for February 2008. As you can see, American companies aren't in the majority (sorry about any formatting errors):
________________________________________

United Nations prequalified vaccines
WHO list of vaccines for purchase by UN agencies as of February 2008

Berna Biotech TT, MR (measles, rubella combination)

Berna Biotech Korea Corp. Hepatitis B (recombinant), DTP-Hep B-Hib (fully liquid pentavalent) (Quinvaxem)

Bio Farma, Indonesia DT, DTP, DTP-Hep B, Hepatitis B filled in Uniject, OPV, TT, TT filled in Uniject, Measles, Measles (20 doses)

Biomanguinhos, Brazil yellow fever (5, 10 and 50 doses) , polysaccharide meningococcal A and C vaccine (10 doses in glass vials)

Center for Genetic Engineering and Biotechnology, Cuba Hepatitis B (recombinant)

Novartis Vaccines and Diagnostics GmbH & Co. KG, Germany (formerly Chiron Behring) DTP, Rabies

Novartis Vaccines and Diagnostics S.r.l, India (formerly Chiron Behring) Rabies

Novartis Vaccines and Diagnostics S.r.l, Italy (formerly Chiron Vaccines) OPV, Hib, DTP-Hib

CSL, Australia DTP, TT

GlaxoSmithKline, Belgium Hepatitis B (recombinant), Hib, OPV (produced in MRC-5), meningococcal A + C, meningococcal ACW 135; DTP-Hep B (Tritanrix), DTP-Hep B to be combined with Hib (pentavalent) (Tritanrix-Hib), DTP-Hep B (Zilbrix), DTP-Hep B + Hib (Zilbrix-Hib), measles, MMR, Rotavirus (Rotarix)*

Haffkine Bio Pharmaceutical Corporation Ltd, India OPV (from bulk supplied by Biofarma, Indonesia)

Institut Pasteur Dakar, Senegal yellow fever

Japan BCG BCG

LG Life Sciences Ltd., Korea Hepatitis B (recombinant)

Merck and Co. Inc, USA Hepatitis B (recombinant), Hib

BB-NCIPD Ltd., Bulgaria, Intervax, Canada BCG, TT, DT, dT

Panacea Biotec, India DTP Biofarma - Hib Novartis (1 dose) (EASYFOUR)

DTP Biofarma - Hepatitis B PHB (1 dose) (1 dose) (ECOVAC) Hepatitis B (Enivac B) OPV (from bulk supplied by Biofarma, Indonesia) OPV (from bulk supplied from Chiron, Italy)

Sanofi Pasteur, France DT, dT, DTP, DTP-Hib, IPV, OPV, TT, measles, MMR, Hib, rabies, yellow fever, meningococcal A + C SBL Vaccin

AB, Sweden Inactivated oral cholera

Serum Institute of India BCG, DT, dT, DTP, DTP-Hep B, Hep B (recombinant), TT, MR, MMR, measles,rubella

Shantha Biotechnics Private Ltd., India Hepatitis B (recombinant), DTP-Hep B (Shantetra), TT (Shan TT)

Statens Seruminstitut, Denmark BCG
______________________________________________

I don't know what other ties there are between WHO and the FDA, but they're not dating the same vaccine manufacturers.

As to my personal credentials, I support litigation against big, bad companies who don't act responsibly and have learned a lot by osmosis in handling and viewing millions of pages of proprietary documents. I also read extensively and my medicine cabinet contains aspirin and a couple OTC ointments - I broke out the Preparation H in honor of this thread. However, much of my family is directly involved in medicine and their chosen fields include: pharmacy, nursing, public health and drug studies. Those with children have always been informed when deciding which vaccines to purchase and, in the 60's and 70's, my Dad purchased our vaccines privately from what he knew to be the highest quality sources.

Additionally, I have a friend who purchases drugs and vaccines for WHO (where and why I became informed about the issues with vaccines) and, living in DC, I am surrounded by highly educated professionals from every field. People talk to me. A lot. That many of my friends and neighbors are career employees of various federal agencies allows me one hell of a perspective on just how broken and subverted the current corporatist system is. If there's one common mantra among them, it's that qualified, educated professionals, not industry insiders, should be running our federal agencies. The career professionals are totally demoralized by the ignorance and unprofessional conduct of their appointed superiors.

While I never claimed that vaccines were responsible for ADD, Autism, Asberger's, bizarre immune disorders or any of the other all-to-common afflictions that didn't exist when I was a kid, you chose to lump me in with that bunch. Boo Hoo, you hurt my wittle feewings. But I'm not anti-vaccine, I'm against contaminated and potentially dangerous vaccines. I'm still willing to accept that vaccines may or may not be either directly responsible or components of the cause, along with a myriad of environmental conditions and food additives that didn't exist or weren't in common use then. If remaining unconvinced on the subject makes me a conspiracy theorist, I hope they'll welcome me aboard the mothership.

Thanks to this thread, my knowledge of vaccine issues is vastly improved. I hope you're happy.

[TZ]

20. ALL those manufactures you mentioned

Have US based places. In fact, I work for someone with manufacturing facilities in Germany, England etc. You do know what CRO's are right? Most american companies don't make vaccines here because of costs. But they do it overseas.
I've actually done work HERE in the US on vaccines for Chiron, MERCK (who is a HUGE AMERICAN COMPANY), GSK, Sanofi-Pasteur,and Novartis. Hmm.I'm an american. So you want to claim that American companies don't "manufacture" good vaccines. That's patently untrue. They all are international companies with STRONG ties to the US. And as someone who has a company that has an INTERNATIONALLY accepted flu vaccine, I call bullshit again.
Again, most of those companies for financial reasons have their manufacturing facilities overseas. But the majority of the safety and toxicology testing is done HERE.
BTW, I worked with WHO on vaccine development at NIH on experimental vaccines. Produced by Merck (here) and approved by the WHO for clinical trials in Africa. Sure sounds like WHO disapproves of US manufacturing techniques:sarcasm:
I'm glad you learned something about vaccines but the truth is WHO would love to see more American companies producing vaccines..Not too many home grown companies do it because of the risk vs. cost. My company has a lot of drugs in the pipeline and on the market that allows them to manufacture some vaccines without going out of business.

[xchrom]

16. kick

[xchrom]

17. kick

[xchrom]

21. kick

[mzmolly]

22. An article by an oncologist on the NIH payroll.

Excuse me for remaining skeptical of his diatribe. His "opinion" offered nothing new.

Perhaps he can shed some light on why the new Rotavirus vaccine is leading to pneumonia? Eh, probably not given he's a cancer surgeon.

http://www.msnbc.msn.com/id/23183636/

[cosmik debris]

23. Are you smart enough to know the difference

between correlation and and causation?

The article you cited from MSNBC/Reuters didn't even say correlation, it said association.

Sometimes the scientific illiteracy here astounds me.

[mzmolly]

24. Are you smart enough to piss the hell off?

Sometimes the blind defense of drug companies here, astounds me.

[cosmik debris]

25. Well, that's certainly a coherent defense.

:rofl:

[mzmolly]

26. As coherent as anything you've said.

:rofl:

[varkam]

27. Let's see...cosmik brought up the (valid) point...

that correlation does not mean causation. You throw a tantrum over defending the drug companies...uh...even though cosmik didn't say anything about drug companies. Yes...very coherent.

[TZ]

28. This same poster believes her scientific knowledge

is superior to mine. Because you know, I am "just" a lab technician and she is an accountant!!

[mzmolly]

32. No, I believe that many ACTUAL scientists are superior to you, a lab tech,

however.

[mzmolly]

29. Let's see ... cosmik stated the obvious while calling me a fear monger,

And, drug companies make vaccines, so I'd say that's coherent" yes ... very coherent.

Double blind studies are designed to uncover potential issues, they are not designed to prove "causation".

[varkam]

30. Uh...actually that's what experiments are for...proving causation.

See, you have an experimental group and a control group. You try to keep all things the same between them except one thing (the independent variable) and then look at various outcomes. If the only thing that is different between the two groups is the IV, then it is a reasonable claim to make that any differences are the result of the manipulation of the IV. That's what an experiment is, in short.

It seems to me that the easiest retort would've just been to say that the conclusions comes as a result of analysis on clinical trials, thereby strengthening the claim that the vaccine is not just correlated with increased deaths but is implicated in them. I guess, in order to do that though, you'd have to refrain from the ad hominems for a moment. Maybe if you were feeling especially sharp you could say that while tossing an ad hom out there.

[mzmolly]

31. Double blind studies used in vaccine trials are not designed to prove causation.

Scientific studies that show an association between a factor and a health effect do not necessarily imply that the factor causes the health effect. Many such studies are preliminary reports that cannot justify any valid claim of causation without considerable additional research, experimentation, and replication.

http://www.saltinstitute.org/rss/environment/2007/11/distinguishing_association_fro.html

It doesn't take a "rocket scientist" to understand that causation in this case, is not established. To insert this "correlation is not causation" meme in thread after thread as though it's some unique epiphany is silly.

I'm off to dinner with the family. Have a nice evening Varkam :hi:

[varkam]

34. Wow.

Scientific studies that show an association between a factor and a health effect do not necessarily imply that the factor causes the health effect. Many such studies are preliminary reports that cannot justify any valid claim of causation without considerable additional research, experimentation, and replication.

I've just been served.

Wait, not really. It's true that many such studies cannot justify such claims...but how exactly does this repudiate what I said about how what experiments are supposed to do is determine causation? What is the additional research, experimentation, and replication that needs to be done? It isn't....an experiment, is it? Many such studies cannot claim causation for a number of reasons, such as small Ns, low statistical power, confounds, et cetera. Also, as a general rule, results of experiments need to be replicated by...well...other experiments. Your claim that double-blind studies aren't meant to determine causation reflects...well...something anyway.

It doesn't take a "rocket scientist" to understand that causation in this case, is not established. To insert this "correlation is not causation" meme in thread after thread as though it's some unique epiphany is silly.

No, it doesn't take a "'rocket scientist'" to understand that causation is not established. Perhaps, given the general lack of scientific education in the health lounge, some posters felt compelled to point that out. Perhaps, given your scary selective bolding of passages, some posters felt compelled to counter-balance the hysteria. Who knows.

To insert this "correlation is not causation" meme in thread after thread as though it's some unique epiphany is silly.

Thread after thread? The drama! :rofl: As far as I can see it, there is one and a half thread on this topic (the rotavirus vaccine). If one and a half threads counts as thread after thread...well...okay.

I'm off to work, so I doubt my evening will be nice.

[mzmolly]

36. Sorry Varkam, you're talking in circles.

As for the thread after thread comment, I've seen the statement in question in many threads, on many subjects. Use the search function if you must.

[varkam]

48. You wrote:

Double blind studies are designed to uncover potential issues, they are not designed to prove "causation".

To which I replied:

Uh...actually that's what experiments are for...proving causation.

And then you said:

Scientific studies that show an association between a factor and a health effect do not necessarily imply that the factor causes the health effect. Many such studies are preliminary reports that cannot justify any valid claim of causation without considerable additional research, experimentation, and replication.

And then finally, I wrote:

Wait, not really. It's true that many such studies cannot justify such claims...but how exactly does this repudiate what I said about how what experiments are supposed to do is determine causation? What is the additional research, experimentation, and replication that needs to be done? It isn't....an experiment, is it? Many such studies cannot claim causation for a number of reasons, such as small Ns, low statistical power, confounds, et cetera. Also, as a general rule, results of experiments need to be replicated by...well...other experiments. Your claim that double-blind studies aren't meant to determine causation reflects...well...something anyway.

So...explain to me how I am talking in circles?

[mzmolly]

50. The discussion is in regard to vaccine trials Varkam.

You left that part out of the quotes above. You also used the term "experiments" vs. double blind studies. "Experiments" are not limited to double blind studies.

Again, you're talking in circles.

[varkam]

52. You're not proving your charge.

You keep claimg that I'm talking in circles, but you haven't really explained how it is that I'm doing that. I'm just asking you for an explanation with regards to how it is that I am, apparently, talking in circles.

No, experiments are not limited to double-blind studies...so what? Experiments are for determining causation, double-blind studies are a type of experiment - do I need to diagram this?

A are B
C are A
---------
Therefore, C are B

Also, I don't see what's so special about vaccine trials in particular. You still have to determine causation, even if all you're looking at is ADRs. That's what these experiments are for...determining causation.

You can drop it any time you'd like, or you can keep claiming that I'm talking in circles. Whichever you prefer.

[mzmolly]

53. I'll allow others to discern for themselves.

The conversation remains on the record.

[varkam]

54. I'm just asking you to state your case. Shouldn't be that hard for you...

especially if it's so clear that anyone passing by can tell that I'm talking in circles. C'mon, mzmolly! 'Splain it to me! I'm just asking for your reasoning behind your claim, now tossed out there a couple of times, that I'm talking in circles.

Or, maybe you were just hoping to shut me down by throwing that out there without any idea of what you were actually talking about. Could be that, too. I thought you always knew what you were talking about, though. Is your Google-Fu failing you?

[mzmolly]

55. I've stated it and I refuse to repeat myself. I think your confusion

speaks for itself.

[varkam]

59. Then just point me to the specific post where you clearly stated your case.

I looked through all the posts in this thread, and nowhere did you explain why it is that I am talking in circles. Perhaps you explained it in another thread?

[mzmolly]

60. You're attempting to move the goal posts from "double blind vaccine studies" to "experiments".

Vaccine studies are designed to demonstrate safety and immunogenicity. When an issue is brought to light, such as the increased pneumonia deaths in the thread I posted http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=2913315&mesg_id=2913315">HERE, it is deemed a "coincidence". Clearly, you know that by now?

Here is ONE example of the "difficulty" proving "causation" in regard to adverse vaccine reactions according to the Canadian Public Health Agency:

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/97vol23/23sup/acs3.html

Although there has been a concern about the possible association of severe neurologic illness (including encephalopathy) occurring within 72 hours of the administration of whole-cell pertussis vaccine, the risk of association is so small compared to the background rate of these types of events that the question of causation cannot be answered. Whether there is a risk of permanent brain damage following pertussis vaccination is even more controversial; available studies have been unable to prove causation.

It's true that many such studies cannot justify such claims...but how exactly does this repudiate what I said about how what experiments are supposed to do is determine causation?

The goals posts moved from the discussion regarding "double blind vaccination studies" which are supposed to determine safety and immunogenicity to "experiments" in general, which are conducted for many reasons.

In all fairness, perhaps you and I had a misunderstanding? I was discussing vaccine trials and you something else?

I'm done with this conversation. :hi:

[varkam]

61. Oy.

The goals posts moved from the discussion regarding "double blind vaccination studies" which are supposed to determine safety and immunogenicity to "experiments" in general, which are conducted for many reasons.

Equivocate much? Both double-blind experiments (such as vaccine trials) are meant to determine causation (does the vaccine cause ADRs, does the vaccine cause the intended effect, etc) and experiments (which, obviously, can have many different research questions, are employed to determine causation). You're essentially just dodging the point, here.

Also, your quote from the Canucks is a red-herring. Difficulty of specific studies in determining causation is not the same thing as an experimental design not being intended to determine causation. In fact, it has relatively little to do with your original (and wrong) claim that double-blind studies are not intended to determine causation.

In all fairness, perhaps you and I had a misunderstanding? I was discussing vaccine trials and you something else?

No. You said that double-blind studies aren't meant to determine causation. That's a statement that is just flat-out wrong, regardless of whether or not you are talking about vaccine trials or something else. I took you to task on it, and you claimed (and still haven't shown) that I was talking in circles.

Perhaps there is a misunderstanding, but I think the misunderstanding is your shallow assumptions as to the nature of the purpose of a double-blind design. Or, perhaps the misunderstanding is mine in that instead of saying double-blind studies aren't meant to determine causation, you meant to say that it is difficult to determine causation with respect to trials on vaccines. If that's the case, then you could've just...you know...said that as opposed to being belligerent.

I'm done with this conversation.

I guess that means I don't need to keep prodding you to provide something you are either unwilling or unable to provide.

[mzmolly]

62. So, by your standards, you feel that the Rotavirus vaccine/pneumonia connection I noted

proves that the vaccine caused said pneumonia in some individuals?

If not, can you can share the pre-licensure/double blind vaccine studies that prove a particular vaccine caused a particular ADR, so that I can better understand what specifically you're trying to communicate?

Perhaps there is a misunderstanding, but I think the misunderstanding is your shallow assumptions as to the nature of the purpose of a double-blind design. Or, perhaps the misunderstanding is mine in that instead of saying double-blind studies aren't "meant" to determine causation, you meant to say that it is difficult to determine causation with respect to trials on vaccines. If that's the case, then you could've just...you know...said that as opposed to being belligerent.

My assertion was in response to the "correlation is not causation" meme as it relates specifically to double blind pre-licensure studies on vaccination. Context in discussion is always important Varkam.

Double blind vaccine studies are "DESIGNED" to demonstrate efficacy and safety, they are not "DESIGNED" to prove "causation" (what scientists regard as sufficient evidence to accept a causal claim) of specific adverse events.

Here is a quote from me above: It doesn't take a "rocket scientist" to understand that causation in this case, is not established. To insert this "correlation is not causation" meme in thread after thread as though it's some unique epiphany is silly.

I think my posts on this have been clear?

Article on establishing "causation" - http://ask.metafilter.com/80526/How-do-we-establish-causation

Edited to add a link to some examples of "study design" from Glaxo: http://ctr.gsk.co.uk/Summary/Vaccine_Hepatitis/studylist.asp

Note, not one study mentions it was "designed" to determine "causation" of a particular ADR. The studies are 'designed' to determine safety and efficacy. However the "safe" thing is eternally debatable as ADR's are generally chalked up to coincidence and the old "correlation is not causation" meme comes in handy, once again.

[varkam]

63. I thought you were done with this conversation. Guess not.

So, by your standards, you feel that the Rotavirus vaccine/pneumonia connection I noted proves that the vaccine caused said pneumonia in some individuals?

Either your not reading what I'm writing, you're going to need some more straw for that giant strawman you're constructing. You posted that double-blind studies aren't intended to prove causation, which is wrong. I never said that this study in particular proves one thing or another.

If not, can you can share the pre-licensure/double blind vaccine studies that prove a particular vaccine caused a particular ADR, so that I can better understand what specifically you're trying to communicate?

I've already said what I'm trying to communicate over and over again, but I'll try it again.

Double-blind studies are a type of experiment wherein the independent variable is manipulated (without either the participants or the experimenters knowing) while everything else is held constant in order to determine the causative effects of the IV. I'm not saying anything about any particular experiment or any particular vaccine or any particular ADR.

My assertion was in response to the "correlation is not causation" meme as it relates specifically to double blind pre-licensure studies on vaccination. Context in discussion is always important Varkam.

So then how is your response that double-blind studies are meant to determine causation relevant to that context, Mzmolly? Aside from being totally wrong, I fail to see how you claiming that double-blind studies aren't intended to determine causation gives you any breathing room.

Double blind vaccine studies are "DESIGNED" to demonstrate efficacy and safety, they are not "DESIGNED" to prove "causation" (what scientists regard as sufficient evidence to accept a causal claim) of specific adverse events.

Wow...that's special. I understand that you don't realize you're contradicting yourself, so I'll break it down for you. You say that these studies are done to determine safety. How is safety determined? They determine whether or not the introduction of the vaccine causes an increase in ADRs in the experimental group versus placebo. The keyword in that last sentence is causes.

I see you're all excited, but only because you fail to understand that determining efficacy and safety, and the larger issue of determining causation and why such trials are performed are actually the same thing.

This is getting a bit silly now, mzmolly. Just drop it.

[mzmolly]

64. Varkam,

I was having a conversation with an individual in more than one thread. Of course you don't know the complete "context" of what was discussed.

- Context -

The GSK Rotavirus vax has been associated with increased cases of pneumonia in pre-license trials.

The "correlation is not causation" meme was inserted into a thread on the matter as if it were not apparent.

In response, I noted that in http://www.journals.uchicago.edu/doi/pdf/10.1086/322561">pre-licensure/double blind vaccine studies "causation" of a particular ADR will not likely be "proven" as such studies are designed to demonstrate safety and efficacy. The Rotavirus issue is an example of this because in spite of the finding I noted, the vaccine has been given a green light by the FDA http://www.thestreet.com/s/fda-panel-blesses-glaxos-rotavirus-vaccine/newsanalysis/biotech/10404288.html?puc=_tscrss">THESTREET.COM

You wish to parse words and play "gotcha" without taking context into consideration.

An aside - why do you think the Rotarix vaccine is on it's way to FDA approval in spite of the possible deadly pneumonia association Varkam? Would you say that the vaccine in question "caused" an increase in pneumonia cases or not? Should the double-blind vaccine trials have fettered that out? Or, do you feel that more studies are needed in order to make such a claim?

I stand by my remarks. And, if I'm feeling better in the am, I'll check back in.

Peace

[varkam]

65. Apparently, you're just not reading my posts.

You posted that double-blind studies are not meant to determine causation with respect to vaccine trials (and yes, I was aware of the context). Regardless, though, your statement is incorrect. That's exactly why double-blind studies are performed: to determine causation.

As far as this particlar vaccine goes, I would say more studies are probably needed (replication)...but you do understand that they're going to be studies of the double-blind variety..right? Cause..you know...that's what those scientists do in order to determine if an IV causes a specific outcome.

You seem to be assuming that I was totally unaware that this discussion was in reference to the Rotarix vaccine, though that assumption would be mistaken. I was aware of the context from the very first post. What I've been harping on for the rest of the discussion, though, is the awe-inspiring comment that you made that double-blind studies are not meant to determine causation with respect to vaccine trials when - in reality - that is precisely what they do. I've been trying to explain that to you, but you seem to be unwilling to acknowledge that (or that you were simply mistaken and meant to add that, perhaps, one study is not sufficient, etc).

Also, it is worth noting that the issue of context is totally irrelevant - as you seemed to be making a statement about double-blind studies in general and not just the Rotarix vaccine.

As to why the vaccine seems headed for approval - I do not know, but that is also irrelevant. It doesn't change the fact that double-blind studies are still used to determine causation (yes, even with respect to vaccines and yes, even with respect to Rotarix).

Okay, I'm done editing now.

[mzmolly]

66. Ditto Varkam.

You have a good one as well. :hi:

[varkam]

67. I'm editing.

I figure I'll give it another go.

[mzmolly]

68. You continue to parse words and avoid context

Varkam.

You posted that double-blind studies are not meant to determine causation with respect to vaccine trials (and yes, I was aware of the context).

With respect to vaccine trials and what else?

A slight correction with context inserted -

Double blind studies in the context of vaccine pre-licensure trials are not meant to determine causation with respect to particular ADR's. ie. >>> is pneumonia CAUSED by the Rotarix vaccine? That's what was being discussed.

From the VSII

The process of evaluating whether a particular vaccine causes an adverse event can start with repeated observations or reports of an adverse event. Then researchers conduct epidemiological studies to determine the risk of the event for vaccinated people compared to unvaccinated people. Still other researchers will try to determine potential biologic mechanisms for the vaccine to cause the event.

As far as this particlar vaccine goes, I would say more studies are probably needed (replication)...but you do understand that they're going to be studies of the double-blind variety..right? Cause..you know...that's what those scientists do in order to determine if an IV causes a specific outcome.

No, such studies can take several forms and generally do.

However, riddle me this - Why are more studies needed? By your criteria, shouldn't the vaccine pre-trial have "established causation"?

Also, do you feel that GSK will be required to conduct "more studies" prior to approval, given they are "probably needed"?

Here is the official take on causation and vaccination: http://www.i4ph.org/vaccine_safety_detail.cfv?id=67

Establishing causality

It is often difficult, time consuming and expensive to answer these types of questions. However, as vaccines are recommended for all children as they are developing, it is critical that the studies be done.

There are a number of factors that are considered in trying to determine whether a vaccine is the cause of an adverse event or disease.(1, 2)

* Time of onset: The onset of the disease must follow vaccination. If symptoms of the disease occurred before vaccination, then the vaccine is not the cause.

* Virus isolation: In the case of a live virus vaccine, a causal relationship between vaccine and disease may often be inferred if the virus is recovered from a normally sterile body site (for example, blood or cerebral spinal fluid).

* Uniqueness of the clinical syndrome: Causation may be inferred if the adverse event or disease only occurs following vaccination and does not occur in persons who did not receive the vaccine. Causation may also be inferred if the adverse event occurs a second time after repeat exposure to the same vaccine.

* Biological mechanism: Biologic mechanisms that could potentially explain how the vaccine might cause the adverse event are not sufficient to prove that the vaccine caused the problem. However, when there is other evidence of an association, such as epidemiologic studies, biologic mechanisms that could explain the association scientifically could help in establishing whether the vaccine caused the problem.

And, most importantly -

* Epidemiological studies: Epidemiological studies often provide the most important evidence as to whether a vaccine caused the problem because most adverse events are not unique clinical syndromes (that is, they also occur in people who did not receive the vaccine). Epidemiological studies determine whether the risk (rate) of the illness of concern is higher in vaccinated persons compared to unvaccinated persons. A higher risk among vaccinated persons could mean that the vaccine caused the problem.

Again - DOUBLE BLIND VACCINE PRE-TRIALS ARE NOT DESIGNED/SUFFICIENT TO ESTABLISH CAUSATION OF A PARTICULAR ADR. UNLESS the event is a "unique clinical syndrome" as described above. Or, unless you consider getting chicken pox from the vaccine an ADR. Regarding this discussion however, pneumonia is not "unique".

Lastly,

Once it has been confirmed that bias, confounding, and chance are not contributing to the observed association, the issue of causation can be addressed. This is the focus of the second section of the figure. A causal association implies that changes in exposure affect frequency of outcome. No single criterion is capable of establishing causation, and not all of the criteria need be supported for a relationship to be causal. Generally, the more supporting evidence there is, the more likely that the association is causal.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1071389

Thanks for the edit. I always enjoy a good vaccine discussion with you Varkam.

In all fairness to you, if my words are taken out of context, they are incorrect. However, as my statement pertains to the conversation, I am satisfied with what I've indicated.

Have a nice day Varkam :hi:

[varkam]

69. Okay.

Are you saying that double-blind trials are not sufficient to determine whether or not a specific vaccine causes a specific ADR? If that's the case, then I agree somewhat. However, there's a mighty big difference between saying that and saying that double-blind studies aren't meant to determine causality. They are. Epidemological studies can provide support for causal notions uncovered during controlled trials, or can provide information for further research, but lack the tight controls seen in scientific experiments and thus are subject to various confounding variables. From the blocks you quoted, note that epidemological studies do not establish causation - they establish an association. I know you hate to hear it, but correlation is not causation.

And I really don't know where you're getting the idea that I said that one study is sufficient to establish causation. Replication is the key word here (and, indeed, in all sciences). I also don't know what you think my "criteria" are for establishing causation. All I've been saying is that double-blind studies (note the plural) are essential to determining causation with respect to vaccine safety and efficacy...which is why the FDA mandates that they be done before they go to market.

[mzmolly]

70. What I'm trying to communicate is clearly stated in

the post you replied to. You did a fair job summarizing here: Are you saying that double-blind trials are not sufficient to determine whether or not a specific vaccine causes a specific ADR? If that's the case, then I agree somewhat.

You also said: I know you hate to hear it, but correlation is not causation.

I have noted extensively in this conversation that the criteria for "establishing causation" as it relates to potential, specific vaccine related ADR's is generally quite complex. I don't hate to hear "it" anymore than I do any obvious drivel noted here ad nauseum.

And, I shall leave it at that.

Peace

[varkam]

72. Well...

you sad that double-blind studies are not intended to determine causation, not that the factors in determining causation are quite complex (which is true). Double-blind studies may not be sufficient for determining causation, but they are, nonetheless, necessary.

[mzmolly]

73. Okey dokey Varkam.

We are essentially in agreement. :hi:

Off to continue watching the debate.

[mzmolly]

58. dup/delete

[cosmik debris]

33. I'm glad you agree that it is obvious

that you are a fear monger. Not that there was ever any doubt.

[mzmolly]

35. If you are afraid of the information provided, that's a personal problem.

Perhaps you can alert on the thread I posted considering you question the validity of statements and/or the "bolding" technique I used. :eyes:

Grow up, clown.

[cosmik debris]

37. Ya can't scare me ya big bully!

Just because you peddle fear doesn't mean I buying it.

I'm certainly not that big a fool as to believe your spin.

When I see your post I just laugh.

Your appeal to emotion always loses when people value reason over emotion.

If you plan to peddle your fear and loathing here, you can expect to be challenged at ever post.

[mzmolly]

38. Perhaps before you laugh too hysterically at others, you can check

your spelling and grammar? Also, I gotta say, I don't consider you a challenge. A joke perhaps, but a "challenge" not so much.

[cosmik debris]

39. OOOOOO! the spelling police are out to get me.

You are really looking petulant now.

Keep digging.

[mzmolly]

40. I think you need a new meme?

The shovel is getting old.

[cosmik debris]

41. When your shit gets too deep, you need two shovels

[mzmolly]

42. Well then, you'll need this:

:P

[cosmik debris]

43. I beat you to it. you just can't win mzcopycat. n/t

[mzmolly]

44. Yes, we cross posted.

Nonsense begets nonsense, and as such, I'm out. Goodnight.

Thanks for the entertainment. :hi:

[cosmik debris]

45. Like I said,

You are always good for a laugh as long as no one takes you seriously.

[mzmolly]

46. Apparently you take me quite seriously, given the amount of time you've spent

googling shovels and all.

Once again, G-Night.

Oh, I plan to post the info from MSNBC in GD soon as well. So, keep your eyes peeled and your shovel links handy.

[cosmik debris]

47. It's like a 40 car pile up.

I just couldn't look away no matter how disastrous your futile posts got.

You just have to gawk at things that crazy,

[xchrom]

49. kick

[xchrom]

51. kick

[xchrom]

56. kick

[xchrom]

57. kick

[Tinita]

71. kick