This guy says the studies were conducted .. 'off label' .. TO ..
"dedeuce" .. "enhanced oxygen delivery" ..
"This was investigated in clinical trials because it was thought that
raising the hemoglobin levels would enhance delivery of oxygen to the
tissue and so enhance delivery of radiation therapy,"
Yeah .. for .. sure ..
A previous study .. http://tinyurl.com/2eocae .. specifically stated
they did THAT study because they .. **feared** .. doctors were giving
too much of the drug to .. "REAP BIG PROFITS" .. instead of the ..
"trying to enhance life" / "enhanced oxygen delivery" .. answer to ..
"why ARE you guys going off label.?"
'They' / doctors get paid BY the shot .. and attempting to raise the
hemoglobin 'off label' was SIMPLY a .. "money making plot" .. BY ..
the medical practitioners or so the investigators / cops who did the
study .. wondered.
Now THIS .. guy .. AGAIN says the study was conducted TO .. attempt to
enhance .. life.
I would tend to believe the .. cops.
The study which found INCREASED DEATH RATE and evidence of ..
malpractice causing death by attempting to PROFIT .. by using PLENTY
of the .. drug .. therefore getting PAID much more .. money ..
http://tinyurl.com/2eocae
Death for profit.
Except in Canada .. as our resident Oncologist points out .. "Canadian
doctors get paid nothing for using of a drug" ..
------------------------------------------------------------------------
Further Restriction of Erythropoietin Use in Cancer Patients Likely
June 13, 2007 - Concerns over the safety of the use of erythropoietin
products in cancer patients have been aired again, this time in 2
Perspective articles in the July 14 issue of the New England Journal
of Medicine. These products, also known as erythropoiesis-stimulating
agents (ESAs), were recently given a black-box warning after evidence
from clinical trials showed a decreased survival in cancer patients,
and these clinical data and their implications were discussed at
length at a Food and Drug Administration (FDA) Oncologic Drugs
Advisory Committee meeting last month.
After all the publicity that has been given to this issue, to maintain
the public trust, "medical oncologists should begin using these agents
in a compassionate but disciplined fashion, placing patient benefit
above all other considerations," comments 1 of the articles. In
addition, the FDA should act transparently in adopting new guidelines,
says the author, Fadlo Khuri, MD, from the Emory Winship Cancer
Institute, in Atlanta, Georgia. The agency is continuing to assess the
risk posed by erythropoietins, and although the recommendations of
advisory committees are not binding, the agency usually follows their
advice. Hence, the FDA is "likely to further restrict the use of
erythropoietins in oncology," predicts the second article, by Robert
Steinbrook, MD, national correspondent for the Journal.
The products involved are epoetin alfa (Epogen, Amgen, for use in
dialysis; Procrit, Ortho, for all other indications, including cancer)
and darbepoetin alfa (Aranesp, Amgen), both marketed in the United
States, as well as epoetin beta (NeoRecormon, Roche), which is
available only in Europe. In the United States, the marketed products
already carry a black-box warning, mandated by the FDA in March 2007,
about the potential for tumor promotion and thromboembolic events. In
addition, FDA instructions require that these products be withheld
from patients whose hemoglobin level exceeds 12 g/dL until the level
falls below 11g/dL, notes Dr. Khuri.
Dr. Steinbrook says further changes that the committee discussed at
its May meeting included:
Restricting use of these agents in specific tumor types in which their
safety is in question until adequate trials are completed and more
data are reviewed.
Defining a hemoglobin level in asymptomatic patients at which
treatment with the agents should be initiated.
Advising discontinuation of erythropoietin treatment after a course of
chemotherapy and reevaluation of the degree of anemia with a
subsequent regimen.
Adverse Outcomes in Cancer Patients
The clinical data suggesting potential harm from erythropoietin use in
cancer patients, which led to the black-box warnings, are discussed in
some detail by Dr. Khuri in his article. Two recent trials (so far
unpublished) have shown a significantly shorter overall survival in
patients on erythropoietin compared with placebo (hazard ratio for
death, 1.30 and 1.37). Both of these trials - the Anemia of Cancer
study involving 989 patients with nonmyeloid cancers and the Lymphoid
Cancers of Anemia Study in 344 patients with lymphoproliferative
cancers - used darbepoetin and were aiming for a high hemoglobin
target (13 to 15 g/dL).
There is also evidence of harm from 4 published studies, Dr. Khuri
notes. Two of these trials were conducted in patients with locally
advanced head-and-neck cancer, 1 was in metastatic breast cancer, and
the other was in metastatic non-small-cell lung cancer (NSCLC). Two of
these trials used epoetin alfa, 1 used epoetin beta, and 1
darbepoetin, and all were targeting hemoglobin levels of 12 g/dL or
more (to 15.5g/dL).
Dr. Khuri notes that at the advisory committee meeting in May, some
experts argued that while waiting for definitive data, oncologists
should refrain from using erythropoietin products in patients with
squamous-cell cancer of the head and neck for whom curative therapy
was intended and advised caution in the use of these agents in
patients undergoing chemotherapy for breast cancer and NSCLC.
Current Use of These Agents In Cancer Patients
Further comments on current use of these agents come from an interview
broadcast on the Journal's Web site with a member of the Oncologic
Drug Advisory Committee, James Doroshow, MD, medical oncologist and
director of the division of cancer treatment and diagnosis at the
National Cancer Institute, in Bethesda, Maryland. Dr. Doroshow
emphasized that erythropoietin products are licensed for use to
relieve the anemia associated with chemotherapy and added that this
use is "certainly appropriate" in cancer patients with hemoglobin
levels less than 8 or 9 g/dL. He also pointed out that there are very
little, if any, data available on the use of these agents in cancer
patients with hemoglobin levels in the 9-to-12-g/dL range.
The recent studies have raised questions over the safety of these
agents when they are used to try to raise hemoglobin levels higher
than 12 g/dL, he continued. This was investigated in clinical trials
because it was thought that raising the hemoglobin levels would
enhance delivery of oxygen to the tissue and so enhance delivery of
radiation therapy, Dr. Doroshow explained. "In that context, however,
unfortunately, the known adverse effect of thromboembolism almost
certainly outweighs any potential benefit, and also there is clear
evidence from at least 2 published studies that there is a decrease in
survival," he said. However, it is not clear at present whether the
diminution in survival is a result of an effect of erythropoietin on
the tumor or whether it is caused by the known adverse effects of
these drugs, he added.
The concerns over use of these products in cancer focuses on the
safety of using these agents to raise the hemoglobin levels above 12 g/
dL, Dr. Doroshow commented. He added, however, that while the adverse
effect on survival has been demonstrated at hemoglobin 12 g/dL and
more, "we simply don't know if survival is also adversely affected at
lower hemoglobin levels," and in view of the publicity given to these
concerns, it will now be impossible to conduct a clinical trial to
find out.
Because of this uncertainty, Dr. Doroshow commented that he personally
would not use erythropoietin products in cancer patients in the range
of hemoglobin 9 to 12 g/dL unless it was in the context of an
appropriate clinical trial with informed consent. He added that he
would also "be very careful" about using these products in certain
tumors, eg, breast cancer and head and neck cancer. In these cancers,
where an adverse effect on survival has already been demonstrated when
target hemoglobin level is above 12 g/dL, there is no way of knowing
whether these products are safe when targeting lower hemoglobin
levels, he said.
N Engl J Med. 2007;356:2445-2448, 2448-2451.
--------------------------------------------------------------------------------
Zosia Chustecka is news editor for Medscape Hematology-Oncology and
prior news editor of jointandbone.org, a website acquired by WebMD. A
veteran medical journalist based in London, UK, she has won a prize
from the British Medical Journalists Association and is a pharmacology
graduate. She has written for a wide variety of publications aimed at
the medical and related health professions. She can be contacted at
[email hidden].
Medscape Medical News 2007. © 2007 Medscape
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