VAERS Data: A possible source of bias

"David Wright" wrote in message
et...
In article ,
Mark Probert wrote:
David Wright wrote:
In article ,
Mark Probert wrote:
David Wright wrote:
In article om,
PeterB wrote:
David Wright wrote:
In article .com,
PeterB wrote:
Vaccine-man wrote:
PeterB wrote:

The fact your sponsors
Excuse me? What do you mean by my "sponsors"?
You are here defending the vaccine makers and their products in a
newsgroup devoted to the alternatives, which means you are
promoting
vaccine.
Which, in and of itself, is nothing to condemn.
Guess again. Promotion of vaccine should be confined to venues
showing
no interest in properly tested pharmaceuticals, such as drug maker
websites and courtroom fools like Barrett.
The fact that vaccines are not tested in the way you think they should
be doesn't mean they aren't "properly tested." It means that (a) you
carefully avoid any information about testing that might interefere
with your worldview, and (b) that your standards for "proper testing"
can never be achieved in the real world.
Precisely. PeteyB has been bleating and braying about randomized
studies
for testing vaccines, when that method of testing is absurd in this
context. RCTs are appropriate for pharmaceuticals and supplements, but
not vaccines.

Oh, I can't agree with that. They do use RCTs for vaccine testing,
double-blinded, placebo-controlled, and everything. Especially for
diseases for which there is no existing vaccine.

From what I have read, it is not the epitome of ethics to use RCTs in
this setting.

I definitely don't follow you on this one. How else are you going to
find out if the vaccine works or has harmful side-effects? They did
RCTs on varicella vaccine. Why wouldn't you use RCTs for vaccines?

I certainly hope that research is fruitful, though I don't know what
to expect. There may be a large number of factors involved, some of
them antagonistic.

For one thing, they have found that methylphenidate exists in two forms,
l-methlphenidate and r-methylphenidate (not sure of precise terminology)
where one has far fewer side effects than the other.

I would have thought it was l- and d- (levo- and dextro-), but I don't
know for sure. But different isomeric properties are not unusual.
PeterB likes to emphasize them for vitamin E, for instance.

Yes, Lovenox and Xopenex are a couple of popular drugs based on the
principle.
--


--Rich

Recommended websites:

http://www.ratbags.com/rsoles
http://www.acahf.org.au
http://www.quackwatch.org/
http://www.skeptic.com/
http://www.csicop.org/

David Wright wrote:
In article om,
PeterB wrote:

David Wright wrote:
In article .com,
PeterB wrote:

Vaccine-man wrote:
PeterB wrote:

The fact your sponsors

Excuse me? What do you mean by my "sponsors"?

You are here defending the vaccine makers and their products in a
newsgroup devoted to the alternatives, which means you are promoting
vaccine.

Which, in and of itself, is nothing to condemn.

Guess again. Promotion of vaccine should be confined to venues showing
no interest in properly tested pharmaceuticals, such as drug maker
websites and courtroom fools like Barrett.

The fact that vaccines are not tested in the way you think they should
be doesn't mean they aren't "properly tested."

Promoting a drug or other medical intervention without knowing the
risk-adjusted benefit means you are engaging in quackery. That's
exactly why DSHEA was designed for dietary supplements, because they
are *not* promoted as drugs. If FDA were as effective in regulating
pharmaceuticals as DSHEA is in regulating dietary supplements, I would
not be here.

It means that (a) you
carefully avoid any information about testing that might interefere
with your worldview...

I cannot avoid information that isn't there. Tally stroking health
surveys are not virology, any more than skipping rocks across a pond is
geology.

and (b) that your standards for "proper testing"
can never be achieved in the real world.

Why are long term RCTs testing 20,000 people not possible? It's sad
that FDA doesn't require this, but not surprising in light of the fact
that most of FDA's budget is subsidized by the drug makers themselves.
Absolutely, your sponsors can afford to spend some of those billions
responsibly.

This is why it's a good thing that you are not the gating authority on
new vaccines.

Your sponsors are those who have a vested interest in that
effort. Simple enough?

Yes, your paranoia is simply shining through again.

How creative.

How accurate.

Hardly.

didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess.

There is no mess.

Sure there is. Whenever you don't actually know the risk-adjusted
benefit for a particular medical intervention, you have a mess on your
hands.

Not so. You have a *possible* mess on your hands. You only have an
actual mess if the intervention does, in fact, have nasty side effects
that are common enough to make its use a bad idea.

All pharmaceuticals have side effects, but no one knows for whom a drug
will be deadly, as opposed to just "nasty."

That's true. It would be wonderful if we had a way to know. But we
don't.

So, you don't actually believe in evidence based medicine. Thanks for
admitting it.

It was the case with HRT, it was the case with Vioxx, and it's
also the case with vaccine.

For the first two, we have actual data backing up your assertion. For
vaccines, we do not.

Sure we do, it's called VAERs. You said the other day that even an
imperfect collection of data on dietary suppelements would be better
than nothing, but this argument magically fails when it comes to a
collection of patient complaints following vaccination.

VAERS is merely a starting point. It tells you where there might be
problems.

And you have no criticism of the drug makers for not getting started
because VAERs is not a collection of documented vaccine damage. That's
quite a convenient arrangement you and your sponsors have there.

A lot of people are alive and well today because of
vaccines.

Studies show that not more than 3.5% of the decline in infectious
disease mortality occured after introduction of vaccine, and no proof
exists to show what portion of that 3.5% can be attributed to vaccine.
All you have is tally stroking health surveys, which is little more
than guesswork.

It wouldn't be "guesswork" in your mind if it were backing up your
beliefs about the horrors of vaccines, now would it?

Evidence based medicine means assessing the risk adjusted benefit for
any medical intervention. If you don't do that, you're engaging in
quackery. If people get sick following vaccine and bother to report
it, it's worth reviewing. It doesn't mean every problem will be
related to vaccine, but you can't know the extent of the problem if you
racing toward your next vaccine campaign with your eyes closed.

Which isn't happening. You can sleep better tonight.

It's exactly what's happening. And I sleep better at night, for one,
because vaccine and I have nothing to do with each other.

Despite your scorn for "tally stroking health surveys," you've yet to
prove any convincing rationale for why they are bad.

As I've said repeatedly, they don't prove anything more than
association. Getting wet while doing a rain dance....

You *claim* they only prove association. Fortunately, I haven't
suffered some sort of breakdown that would cause me to take your
claims on faith.

You also haven't suffered any sort of connection to reality.

PeterB

David Wright wrote:
In article ,
Mark Probert wrote:
David Wright wrote:
In article ,
Mark Probert wrote:
David Wright wrote:
In article om,
PeterB wrote:
David Wright wrote:
In article .com,
PeterB wrote:
Vaccine-man wrote:
PeterB wrote:

The fact your sponsors
Excuse me? What do you mean by my "sponsors"?
You are here defending the vaccine makers and their products in a
newsgroup devoted to the alternatives, which means you are promoting
vaccine.
Which, in and of itself, is nothing to condemn.
Guess again. Promotion of vaccine should be confined to venues showing
no interest in properly tested pharmaceuticals, such as drug maker
websites and courtroom fools like Barrett.
The fact that vaccines are not tested in the way you think they should
be doesn't mean they aren't "properly tested." It means that (a) you
carefully avoid any information about testing that might interefere
with your worldview, and (b) that your standards for "proper testing"
can never be achieved in the real world.
Precisely. PeteyB has been bleating and braying about randomized studies
for testing vaccines, when that method of testing is absurd in this
context. RCTs are appropriate for pharmaceuticals and supplements, but
not vaccines.
Oh, I can't agree with that. They do use RCTs for vaccine testing,
double-blinded, placebo-controlled, and everything. Especially for
diseases for which there is no existing vaccine.
From what I have read, it is not the epitome of ethics to use RCTs in
this setting.

I definitely don't follow you on this one. How else are you going to
find out if the vaccine works or has harmful side-effects? They did
RCTs on varicella vaccine. Why wouldn't you use RCTs for vaccines?

From what I understand a small RCT may be used, but larger studies are
not, because if a vaccine is shown to be effective in smaller studies,
giving placebos in larger ones would be unethical.

Of course, I do recall that the original large IPV tests, in which I was
a participant, did have placebo.

I certainly hope that research is fruitful, though I don't know what
to expect. There may be a large number of factors involved, some of
them antagonistic.
For one thing, they have found that methylphenidate exists in two forms,
l-methlphenidate and r-methylphenidate (not sure of precise terminology)
where one has far fewer side effects than the other.

I would have thought it was l- and d- (levo- and dextro-),

You thought correctly.

but I don't
know for sure. But different isomeric properties are not unusual.
PeterB likes to emphasize them for vitamin E, for instance.

In article .com,
PeterB wrote:

David Wright wrote:
In article om,
PeterB wrote:

David Wright wrote:
In article .com,
PeterB wrote:

Vaccine-man wrote:
PeterB wrote:

The fact your sponsors

Excuse me? What do you mean by my "sponsors"?

You are here defending the vaccine makers and their products in a
newsgroup devoted to the alternatives, which means you are promoting
vaccine.

Which, in and of itself, is nothing to condemn.

Guess again. Promotion of vaccine should be confined to venues showing
no interest in properly tested pharmaceuticals, such as drug maker
websites and courtroom fools like Barrett.

The fact that vaccines are not tested in the way you think they should
be doesn't mean they aren't "properly tested."

Promoting a drug or other medical intervention without knowing the
risk-adjusted benefit means you are engaging in quackery.

Given your fondess for attempting to redefine words, I'm not surprised
you'd say that, but you're wrong. After all, we'll never know the
risk-adjusted benefit to YOUR satisfaction, so no doctor would ever be
able to do anything at all.

Quackery is either fraud, or pretending to have medical skill where
none is present. Neither of these applies here.

That's exactly why DSHEA was designed for dietary supplements,

No, it was developed to prevent the supplement industry from having to
prove that their products even contain the supposed ingredients, or
from having to suffer any other kind of regulation. It was put forth
by the supplement industry's friends in Congress. Figures you'd
defend it.

because they are *not* promoted as drugs.

Sure they are. Only someone who'd never seen the kinds of claims made
for some supplements would say what you just said -- unless he were a
paid PR flack, I mean.

If FDA were as effective in regulating pharmaceuticals as DSHEA is in
regulating dietary supplements, I would not be here.

Yes, you'd still be here. What regulation has DSHEA really provided?
How many fraudulent promoters have been slapped down or shut down?
Why don't you regale us with a few inspirational cases.

It means that (a) you
carefully avoid any information about testing that might interefere
with your worldview...

I cannot avoid information that isn't there. Tally stroking health
surveys are not virology, any more than skipping rocks across a pond is
geology.

Yet another meaningless analogy. Your constant whining about "tally
stroking" surveys does not show them to be at all flawed.

and (b) that your standards for "proper testing"
can never be achieved in the real world.

Why are long term RCTs testing 20,000 people not possible?

Well, for one thing, you do have the problem of defining "long term."
In you case, I believe it to mean "at least five generations." That's
really too long to wait. In addition, 20,000 people could easily not
be enough to find those one-in-a-million reactions. Reactions, I
should add, that you would spend many, many posts complaining about.

It's sad that FDA doesn't require this, but not surprising in light
of the fact that most of FDA's budget is subsidized by the drug
makers themselves. Absolutely, your sponsors can afford to spend some
of those billions responsibly.

If only I had such sponsors. But you know, if I had to be paid to
respond to you, I probably wouldn't even bother.

This is why it's a good thing that you are not the gating authority on
new vaccines.

Your sponsors are those who have a vested interest in that
effort. Simple enough?

Yes, your paranoia is simply shining through again.

How creative.

How accurate.

Hardly.

On the contrary, perfectly accurate, since nobody here is being paid
to oppose you.

didn't properly study the effects or safety of
vaccines before marketing them is why we're in this mess.

There is no mess.

Sure there is. Whenever you don't actually know the risk-adjusted
benefit for a particular medical intervention, you have a mess on your
hands.

Not so. You have a *possible* mess on your hands. You only have an
actual mess if the intervention does, in fact, have nasty side effects
that are common enough to make its use a bad idea.

All pharmaceuticals have side effects, but no one knows for whom a drug
will be deadly, as opposed to just "nasty."

That's true. It would be wonderful if we had a way to know. But we
don't.

So, you don't actually believe in evidence based medicine. Thanks for
admitting it.

Gee, PeterB, your mastery of the unfounded conclusion remains intact.
No ordinary human could possibly have arrived at that result.

It was the case with HRT, it was the case with Vioxx, and it's
also the case with vaccine.

For the first two, we have actual data backing up your assertion. For
vaccines, we do not.

Sure we do, it's called VAERs. You said the other day that even an
imperfect collection of data on dietary suppelements would be better
than nothing, but this argument magically fails when it comes to a
collection of patient complaints following vaccination.

VAERS is merely a starting point. It tells you where there might be
problems.

And you have no criticism of the drug makers for not getting started
because VAERs is not a collection of documented vaccine damage. That's
quite a convenient arrangement you and your sponsors have there.

The people who pay you to post this garbage are really not getting
their money's worth. I don't know whether the vaccine makers should
be responsible for the collection or not. Even if they were, you'd
accuse them of hiding all the bad data, so what's the point? But
since vaccines are largely government mandated (for school attendance,
e.g.), it makes sense to have a government collection. The problem is
that VAERS is such a lousy system. There should be much better review
of the submitted cases to weed out the silly ones.

A lot of people are alive and well today because of
vaccines.

Studies show that not more than 3.5% of the decline in infectious
disease mortality occured after introduction of vaccine, and no proof
exists to show what portion of that 3.5% can be attributed to vaccine.
All you have is tally stroking health surveys, which is little more
than guesswork.

It wouldn't be "guesswork" in your mind if it were backing up your
beliefs about the horrors of vaccines, now would it?

Evidence based medicine means assessing the risk adjusted benefit for
any medical intervention. If you don't do that, you're engaging in
quackery. If people get sick following vaccine and bother to report
it, it's worth reviewing. It doesn't mean every problem will be
related to vaccine, but you can't know the extent of the problem if you
racing toward your next vaccine campaign with your eyes closed.

Which isn't happening. You can sleep better tonight.

It's exactly what's happening. And I sleep better at night, for one,
because vaccine and I have nothing to do with each other.

That makes me sleep better too. You're much more likely to be carried
off by some disease you could have avoided. I know you think your
wonderful diet will protect you against anything. But it won't.

Despite your scorn for "tally stroking health surveys," you've yet to
prove any convincing rationale for why they are bad.

As I've said repeatedly, they don't prove anything more than
association. Getting wet while doing a rain dance....

You *claim* they only prove association. Fortunately, I haven't
suffered some sort of breakdown that would cause me to take your
claims on faith.

You also haven't suffered any sort of connection to reality.

You PR flacks do get tiresomely repetitious after a while.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If you can't say something nice, then sit next to me."
-- Alice Roosevelt Longworth

In message , Mark Probert wrote:

From what I understand a small RCT may be used, but larger studies are
not, because if a vaccine is shown to be effective in smaller studies,
giving placebos in larger ones would be unethical.

Of course, I do recall that the original large IPV tests, in which I was
a participant, did have placebo.

It's generally considered bad form to go back all the way
to the inventions of fire and the wheel. Best practice is,
in almost all fields, derived incrementally.

In the case of vaccines, "incremental" means a comparison to
present best practice -- anything else, as you note, would
be unethical. If "present best practice" is "no vaccine,"
as it was for the early polio vaccines, you get placebo.

Despite PB's attempts at mathematical masturbation, it's not
too hard to design an experiment that settles the risk/benefit
relationship to a degree much better than that required by
people in ordinary life, and *vastly* better than any established
for "nutritional medicine," which is scrupulously unstudied.

Example: the incidence of measles in an unvaccinated population
is at least 20% of any birth cohort [1]. Case mortality is 1/1000,
ignoring other adverse consequences. Net mortality is thus about
20/100,000. A study on 100,000 which produces (made up numbers)
50% reduction in incidence and 3 fatalities ascribable to the
vaccine would have an extremely high confidence of being a net
benefit. More reduction or fewer adverse reactions would just
frost the cake.

Post-market surveillance pulls in even more data, of course.

[1] More like 100%, but despite being a reportable illness the
reporting rate was never all that good. 20% is the reported
incidence for the US in the 1960-1965 time period.

--
begin signature.exe
A:*Because*it*messes*up*the*order*in*which*people* normally*read*text.
Q:*Why*is*top-posting*such*a*bad*thing?
A:*Top-posting.
Q:*What*is*the*most*annoying*thing*on*usenet?