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Anemia treatment increases death
Anemia treatment increases death
**MONEY** might well explain WHY the FDA did not issue a warning on
erythropoietin until nine months after the initial study.
Billions of lost .. revenue.
<<snip>>
Amgen was "fairly contrite about not telling us about it"
<<snip>>
February 16, 2007
Study data for Amgen's Aranesp raise concerns
by Alison Fischer
Preliminary data from an independent study investigating Amgen's
Aranesp (darbepoetin alfa) for an unapproved use in patients with head
and neck cancer undergoing radiotherapy, revealed a "small, but
significant poor outcome" in those who received the drug. The study,
conducted by the Danish Head and Neck Cancer Group, was temporarily
halted in October and a decision not to resume the trial was made in
December.
The trial, which involved more than 500 patients, was designed to test
whether Aranesp enhanced radiation therapy in patients with head and
neck cancer, Forbes reports. However, the preliminary findings showed
that those who were administered Aranesp experienced recurrent tumours
more frequently than those who did not receive the drug.
Amgen was made aware of the study's preliminary data in December and
although it informed regulators, it did not disclose the findings to
investors until Friday. Some analysts questioned Amgen's timing,
including Sanford C. Bernstein's Geoffrey Porges, who remarked that
Amgen was "fairly contrite about not telling us about it. I don't
think that's going to give investors a lot of comfort about their
disclosure policies," Forbes reports.
Meanwhile, Roger Perlmutter, Amgen's executive vice president for R&D,
stated that "we do not know anything about the [study] data other than
what was posted on [the Danish Head and Neck Cancer Group's] Web
site," as reported in The Washington Post. Nonetheless, the company's
CEO Kevin Sharer remarked that, in retrospect, the findings should
have been revealed even though the company has not seen the raw data
from the trial, Forbes reports.
Morgan Stanley's Steven Harr commented that "this trial raises the
question again of whether Aranesp promotes cancer growth, and given
some previous trials with similar conclusions and the recent negative
data in other areas we expect physicians and regulators are likely to
continue to question the proper role of Aranesp, [Amgen's] Epogen and
other drugs in the treatment of anaemia," as reported in The
Washington Post.
Miller Tabak & Co. analyst, Les Funtleyder, added that he believes
"there will be more data that comes out that shows [that Aranesp is
not useful in every circumstance] and the market isn't as big" as
Amgen suggests, Bloomberg reports. Last month Amgen revealed that a
separate study of Aranesp showed an increased risk of death in
patients with cancer who received the drug.
Aranesp, which is approved to treat anaemia associated with chronic
renal failure, and to treat anaemia in some patients undergoing
chemotherapy, had sales of just over $4 billion in 2006.
Who loves ya.
Tom
Jesus Was A Vegetarian!
* jesuswasavegetarian.7h . com
Man Is A Herbivore!
* tinyurl . com /a3cc3
DEAD PEOPLE WALKING
* tinyurl . com /zk9fk
**MONEY** might well explain WHY the FDA did not issue a warning on
erythropoietin until nine months after the initial study.
Billions of lost .. revenue.
<<snip>>
Amgen was "fairly contrite about not telling us about it"
<<snip>>
February 16, 2007
Study data for Amgen's Aranesp raise concerns
by Alison Fischer
Preliminary data from an independent study investigating Amgen's
Aranesp (darbepoetin alfa) for an unapproved use in patients with head
and neck cancer undergoing radiotherapy, revealed a "small, but
significant poor outcome" in those who received the drug. The study,
conducted by the Danish Head and Neck Cancer Group, was temporarily
halted in October and a decision not to resume the trial was made in
December.
The trial, which involved more than 500 patients, was designed to test
whether Aranesp enhanced radiation therapy in patients with head and
neck cancer, Forbes reports. However, the preliminary findings showed
that those who were administered Aranesp experienced recurrent tumours
more frequently than those who did not receive the drug.
Amgen was made aware of the study's preliminary data in December and
although it informed regulators, it did not disclose the findings to
investors until Friday. Some analysts questioned Amgen's timing,
including Sanford C. Bernstein's Geoffrey Porges, who remarked that
Amgen was "fairly contrite about not telling us about it. I don't
think that's going to give investors a lot of comfort about their
disclosure policies," Forbes reports.
Meanwhile, Roger Perlmutter, Amgen's executive vice president for R&D,
stated that "we do not know anything about the [study] data other than
what was posted on [the Danish Head and Neck Cancer Group's] Web
site," as reported in The Washington Post. Nonetheless, the company's
CEO Kevin Sharer remarked that, in retrospect, the findings should
have been revealed even though the company has not seen the raw data
from the trial, Forbes reports.
Morgan Stanley's Steven Harr commented that "this trial raises the
question again of whether Aranesp promotes cancer growth, and given
some previous trials with similar conclusions and the recent negative
data in other areas we expect physicians and regulators are likely to
continue to question the proper role of Aranesp, [Amgen's] Epogen and
other drugs in the treatment of anaemia," as reported in The
Washington Post.
Miller Tabak & Co. analyst, Les Funtleyder, added that he believes
"there will be more data that comes out that shows [that Aranesp is
not useful in every circumstance] and the market isn't as big" as
Amgen suggests, Bloomberg reports. Last month Amgen revealed that a
separate study of Aranesp showed an increased risk of death in
patients with cancer who received the drug.
Aranesp, which is approved to treat anaemia associated with chronic
renal failure, and to treat anaemia in some patients undergoing
chemotherapy, had sales of just over $4 billion in 2006.
Who loves ya.
Tom
Jesus Was A Vegetarian!
* jesuswasavegetarian.7h . com
Man Is A Herbivore!
* tinyurl . com /a3cc3
DEAD PEOPLE WALKING
* tinyurl . com /zk9fk
