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Old 12-09-2006, 04:48 AM
ironjustice@aol.com
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Default Medical forensics / Guessing death incidence

Since we KNOW the CHOIR study led to an increased .. death .. incidence
of .. 33% .. anyone care to venture how many of THESE .. poor .. souls
... are no longer .. with .. us .. ?

http://clinicaltrials.gov/ct/show/NCT00354341

(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With
Early Diabetic Nephropathy

This study has been completed.

<<snip>>
This 15-month, multicentre study will randomise 160 adult patients with

diabetes, early-stage renal insufficiency and moderate anaemia
(haemoglobin
11-12.5 g/dl) to either early treatment of anaemia with epoetin beta
(target
haemoglobin 13-15 g/dl) or standard treatment (no anaemia correction
with
erythropoietin therapy until haemoglobin levels fall below 10.5 g/dl).
<<snip>>
-----------------------------------------------------

The study seems to have attempted to raise the hemoglobin into the area
of .. death ..

I wonder if it .. worked ..

Half were treated more aggressively to drive their hemoglobin levels to

13.5 grams per deciliter, while the rest had a target hemoglobin of
11.3 grams per deciliter.
Patients with the higher hemoglobin target were more likely to die,
have a heart attack or stroke, or be hospitalized for congestive heart
failure, researchers said.

http://tinyurl.com/ylkuwx

US FDA says reviewing J&J anemia drug study
Wed Nov 15, 2006 7:24pm ET
WASHINGTON, Nov 15 (Reuters) - U.S. regulators are reviewing a study
showing kidney disease patients treated more aggressively with Johnson
& Johnson's (JNJ.N: Quote, Profile, Research) anemia drug Procrit had a

higher risk of cardiac complications, officials said on Wednesday.


The Food and Drug Administration likely will issue a public health
advisory to alert doctors and patients to the findings, an FDA
spokeswoman said.


The study, called CHOIR, evaluated 1,432 chronic kidney disease
patients treated with Procrit to boost levels of oxygen-carrying
hemoglobin in the blood.


Half were treated more aggressively to drive their hemoglobin levels to

13.5 grams per deciliter, while the rest had a target hemoglobin of
11.3 grams per deciliter.
Patients with the higher hemoglobin target were more likely to die,
have a heart attack or stroke, or be hospitalized for congestive heart
failure, researchers said.


Procrit is a genetically engineered version of a natural protein called

erythropoietin.


"FDA will fully evaluate the CHOIR study data and determine if any
additional actions are necessary in order to optimize the use of the
recombinant human erythropoietin products," the FDA spokeswoman said.


Procrit was licensed to Johnson & Johnson by Amgen Inc. (AMGN.O: Quote,

Profile, Research), which sells its version of the drug under the name
Epogen for treating patients on kidney dialysis. Amgen also markets
Aranesp, a longer-lasting version of Epogen.


The Procrit findings were presented at a medical meeting in April and
published in Thursday's edition of the New England Journal of Medicine.



Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug
Evaluation and Research, said the agency will consider if dosing
recommendations or other parts of the erythropoietin drug labels need
to be changed.


For now, "our recommendation would be to focus on the current labeling"

that gives detailed dosing advice, he said.


Johnson & Johnson spokeswoman Stephanie Fagan said the CHOIR findings
reinforced the Procrit label directions that advise driving hemoglobin
to 10 and 12 grams per deciliter.


© Reuters 2006. All Rights Reserved.


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  #2  
Old 12-10-2006, 11:06 PM
Beav
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Default Re: Medical forensics / Guessing death incidence


<ironjustice@aol.com> wrote in message news:1165636640..googlegroups.com...
Since we KNOW the CHOIR study led to an increased .. death .. incidence
of .. 33% .. anyone care to venture how many of THESE .. poor .. souls
... are no longer .. with .. us .. ?


Still using a fucked keyboard I see.



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