Re: 2/3 of FDA-approved drugs never studied for adverse effects, a required prerequisite to approval


<James216440@xxxxxxxxx> wrote in message
news:1142007380.631950.324000@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Robert wrote:

<James216440@xxxxxxxxx> wrote in message
news:1141920776.708822.216250@xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Why do you keep posting inane nonsense about the FDA approval process
after you have repeatedly demonstrated you have just about exactly zero
actual knowledge about the process or how science works? What Mrs Hope
posted on the process is exactly how it works. Yes to get

As past member of the hospital research committee that approved research
to
be done or not done at our institution, including the statin AE study,
you
don't know what you are talking about.
I had reviewed several hundred clinical trials, about 5 per month for
years,
and have not even remotely seen what you are implying.
A minority of people are excluded and specified in each protocol. One can
go
back and see the stated exclusion and make judgments based on that
exclusion
as a class. Nobody is hiding anything.
Nobody would make a drug for treatment in diabetes and then exclude
diabetics in the study. Not all diabetics have renal failure so an
exclusion
of renal failure would be understandable and stated in the protocol. This
exclusion would be based on renal failure and not just diabetics with
renal
failure.
The company is not going to study a drug with every conceivable condition
and disease. That's impossible. Are you going to do a 5 year study with
albinos and each condition or multiple conditions?
Are you going to do a study with women who have breast implants and the
drug
and then if they come down with autoimmune disease you guys can blame it
on
the drug?
A person with multiple organ failure and is given the drug and then have
to
study it for 10 years to see if it was the drug or the condition that
killed
him?
I have never heard anything stupid and idiotic and unscientific in my
life.
Experiments are controlled and exclusionary by definition. Take a class
in
science.


Thank you for so clearly making my point. You do not study a drug to
treat diabetes without first excluding all non diabetics. You do not
study a drug intended to treat diabetes on a chonic basis in a five
year study without first excluding all diabetics who are on kidney
dialysis or had a heart attack six months ago. You do not run a five
year study on a drug to lower cholesterol without excluding all people
who do not have diagnosed heart disease but are basically healthy
otherwise and have very high odds of living five years without the drug
thereby excluding most of the population.

sorry...you are totally wrong...

if you think the statin clinical trials excluded "all people who do not have
diagnosed heart disease...etc" you don't know squat

as I said...I was in a statin clinical trial...had NO diagnosed heart
disease...was female and age 50...how come they didn't exclude me??



If these examples are not
examples of excluding most of the population from studies I will eat
the thesis that backed up my PhD in science.

I have never met nor talked to Mrs Hope nor her husband. But I do
think the gross exagerations and lies told by bill and listener need to
be pointed out from time to time. They huff and puff and make a lot of
noise. Neither of them has the slightest knowledge of science or the
regulatory process nor how to interpret data. They are simply nazi
skinheads dedicated to the idea that statins are the greatest thing
since sex. Neither can understand that as used these drugs are doing
more damage to society then good.


tidbit...I have a sister an RN with 20 years experience in cardiac rehab

granted her patients have all had diagnosed heart disease..

however...every cardiologist she knows...even the 40 year old ones..have
themselves on statins (unless they get adverse effects)

whether or not in 20 years they will all have less "events" remains to be
seen

no one here has EVER intimated that popping that pill is the cure all...

we all know that "lifestyle modifications" are a bigger factor than a number
on a lab slip

however...many many cannot get the number down...and choose the
"risk/benefit ratio" of adding a pill to their regimen of good diet..weight
control and exercise

in cardiac risk assessment we have always taught the "risks you cannot
change vs the risks you can"

one cannot change their age..gender..family history...or events that have
already occurred..which increase the possibility of a second one...

do you work in a medical setting?? or do you throw your pHd around while
you sit in a totally unrelated field...

there is science...and there is medicine (experience etc)....if you are a
health care provider seeing patients all day all week..you would perhaps
have a more realistic perception of what risk/benefit actually means

my h.o.

And all I can say about listeners
claim to be jewish is he is the kind of person who gives us real jews a
bad name.



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