G
gerry
Guest
The Food and Drug Administration will eventually rue the day it
allowed GlaxoSmithKline PLC to market its new anti-cancer drug,
Tykerb. GSK is a company that puts profits ahead of everything. GSK
is now facing a multi-billion lawsuit loss with the way it
fraudulently handled drug test results of its drug Paxil as an anti-
depressant for teenagers. Paxil in drug trials worked as well as a
placebo on teenage depression, with one problem. Paxil teenage users
started committing suicide at alarming rates. The BBC Panorama show
of 1/29/07, "Secrets of the Drug Trials," had the whole sordid story.
How GSK has maintained patent protection for Paxil since 1981 is a
whole other story, showing how GSK's predecessor gamed the system by
providing false information to regulators.
Burroughs-Wellcome, bought in 2000 by what is now GSK, made a fortune
off the AIDS drug AZT, even though US government scientists developed
the drug at taxpayer expense. The Clinton administration dropped the
ball on the lawsuit contesting the right of Burroughs-Wellcome to
obtain an AZT patent, no surprise considering Clinton AG Reno's track
record showing complete incompetence but a great ability to lie to the
American public. But to secure their profits against any more pesky
lawsuits, Burroughs-Wellcome let itself be taken over.
All other things being equal, Tykerb will probably turn out to cause
cardiac infarctions in women under 50, a fact hidden in the GSK drug
trials for this essentially useless (but very expensive) drug. A
$2,900 a month drug cost for a two month delay in tumor growth, based
on drug trials cut short before there could be any finding that this
delay was a statistical anomaly. Welcome to the world of corporate
greed.
-----
Tuesday, Mar. 13, 2007
FDA Approves Advanced Breast Cancer Drug
By AP/ANDREW BRIDGES
http://www.time.com/time/printout/0,8816,1598883,00.html
WASHINGTON - Women with an aggressive form of advanced breast cancer
that other treatments have failed to stop gained a new option Tuesday
with the approval of a novel drug - but how much benefit it offers is
unclear.
The GlaxoSmithKline PLC drug, Tykerb, is to be taken once daily in
pill form and is meant for women who have received prior treatment
with the intravenous drug Herceptin and older chemotherapy drugs
called taxanes and anthracyclines, the company said. The Food and Drug
Administration said it approved Tykerb for use in conjunction with the
chemotherapy drug Xeloda.
Glaxo said Tykerb would be available in two weeks. It will cost about
$2,900 a month, the company said.
The initial results of a study reported last year showed that Tykerb
in combination with Xeloda delayed tumor growth for an average of 8
1/2 months, or about twice as long as Xeloda alone. Tykerb worked so
well that the international study was stopped early and all
participants were offered the drug.
However, Glaxo said a later analysis of the results of that study
showed the delay actually was closer to nearly seven months for women
on both drugs, versus almost five months for those on Xeloda alone.
The FDA said it was too early to know if women taking Tykerb and
Xeloda would live longer than those taking the latter drug alone. The
lack of that information has left one advocacy group disappointed.
Survival - and not progression of disease - gives a truer picture of a
cancer drug's efficacy, Barbara A. Brenner, the executive director of
Breast Cancer Action, told the FDA in a March 5 letter. "The FDA
should not approve drugs that have not shown either a survival benefit
or improved quality of life for breast cancer patients with metastatic
disease," Brenner's letter read in part.
FDA drugs chief Dr. Steven Galson said Tykerb expanded the options
available to women with a type of advanced breast called HER2 positive
when it has metastasized, or spread. "Today's approval is a step
forward in making new treatments available for patients who have
progression of their breast cancer after treatment with some of the
most effective breast cancer therapies available," Galson said.
Tykerb, like Herceptin, is part of a new generation of cancer
medicines that more precisely target tumors without killing lots of
healthy cells. Herceptin has been an important option for many women
with advanced, HER2 positive breast cancer, but eventually it stops
working and women succumb to the disease.
Both drugs target a protein called HER-2/neu, which tumors make in
abnormally large quantities in roughly one-fourth of all breast
cancers. While Herceptin targets the outside of the HER2 protein,
Tykerb works from the inside of the cell. Because of that difference,
Tykerb works in some HER2 positive breast cancers that have been
treated with Herceptin but no longer benefit from the older drug, the
FDA said.
Generally, women with HER2 positive breast cancer face a greater risk
of disease progression and death. Approximately 8,000 to 10,000 women
die from metastatic HER2 positive breast cancer each year, the FDA
said.
Xeloda, or capecitabine, is made by Switzerland's Roche Holding AG.
South San Francisco-based Genentech Inc. makes Herceptin, also known
as trastuzumab.
Eventually, Tykerb could be studied for use with Herceptin, said Dr.
Len Lichtenfeld, deputy chief medical officer of the American Cancer
Society. And Glaxo said it's studying Tykerb as a treatment for other
cancers.
"Some of those reports have been promising and others less so. But it
is too early to know which other cancers - if any - are going to
respond to this new drug," Lichtenfeld said.
Expanded use of Tykerb eventually could make it a blockbuster drug for
Glaxo, with annual sales approaching or exceeding $1 billion, analysts
have said.
allowed GlaxoSmithKline PLC to market its new anti-cancer drug,
Tykerb. GSK is a company that puts profits ahead of everything. GSK
is now facing a multi-billion lawsuit loss with the way it
fraudulently handled drug test results of its drug Paxil as an anti-
depressant for teenagers. Paxil in drug trials worked as well as a
placebo on teenage depression, with one problem. Paxil teenage users
started committing suicide at alarming rates. The BBC Panorama show
of 1/29/07, "Secrets of the Drug Trials," had the whole sordid story.
How GSK has maintained patent protection for Paxil since 1981 is a
whole other story, showing how GSK's predecessor gamed the system by
providing false information to regulators.
Burroughs-Wellcome, bought in 2000 by what is now GSK, made a fortune
off the AIDS drug AZT, even though US government scientists developed
the drug at taxpayer expense. The Clinton administration dropped the
ball on the lawsuit contesting the right of Burroughs-Wellcome to
obtain an AZT patent, no surprise considering Clinton AG Reno's track
record showing complete incompetence but a great ability to lie to the
American public. But to secure their profits against any more pesky
lawsuits, Burroughs-Wellcome let itself be taken over.
All other things being equal, Tykerb will probably turn out to cause
cardiac infarctions in women under 50, a fact hidden in the GSK drug
trials for this essentially useless (but very expensive) drug. A
$2,900 a month drug cost for a two month delay in tumor growth, based
on drug trials cut short before there could be any finding that this
delay was a statistical anomaly. Welcome to the world of corporate
greed.
-----
Tuesday, Mar. 13, 2007
FDA Approves Advanced Breast Cancer Drug
By AP/ANDREW BRIDGES
http://www.time.com/time/printout/0,8816,1598883,00.html
WASHINGTON - Women with an aggressive form of advanced breast cancer
that other treatments have failed to stop gained a new option Tuesday
with the approval of a novel drug - but how much benefit it offers is
unclear.
The GlaxoSmithKline PLC drug, Tykerb, is to be taken once daily in
pill form and is meant for women who have received prior treatment
with the intravenous drug Herceptin and older chemotherapy drugs
called taxanes and anthracyclines, the company said. The Food and Drug
Administration said it approved Tykerb for use in conjunction with the
chemotherapy drug Xeloda.
Glaxo said Tykerb would be available in two weeks. It will cost about
$2,900 a month, the company said.
The initial results of a study reported last year showed that Tykerb
in combination with Xeloda delayed tumor growth for an average of 8
1/2 months, or about twice as long as Xeloda alone. Tykerb worked so
well that the international study was stopped early and all
participants were offered the drug.
However, Glaxo said a later analysis of the results of that study
showed the delay actually was closer to nearly seven months for women
on both drugs, versus almost five months for those on Xeloda alone.
The FDA said it was too early to know if women taking Tykerb and
Xeloda would live longer than those taking the latter drug alone. The
lack of that information has left one advocacy group disappointed.
Survival - and not progression of disease - gives a truer picture of a
cancer drug's efficacy, Barbara A. Brenner, the executive director of
Breast Cancer Action, told the FDA in a March 5 letter. "The FDA
should not approve drugs that have not shown either a survival benefit
or improved quality of life for breast cancer patients with metastatic
disease," Brenner's letter read in part.
FDA drugs chief Dr. Steven Galson said Tykerb expanded the options
available to women with a type of advanced breast called HER2 positive
when it has metastasized, or spread. "Today's approval is a step
forward in making new treatments available for patients who have
progression of their breast cancer after treatment with some of the
most effective breast cancer therapies available," Galson said.
Tykerb, like Herceptin, is part of a new generation of cancer
medicines that more precisely target tumors without killing lots of
healthy cells. Herceptin has been an important option for many women
with advanced, HER2 positive breast cancer, but eventually it stops
working and women succumb to the disease.
Both drugs target a protein called HER-2/neu, which tumors make in
abnormally large quantities in roughly one-fourth of all breast
cancers. While Herceptin targets the outside of the HER2 protein,
Tykerb works from the inside of the cell. Because of that difference,
Tykerb works in some HER2 positive breast cancers that have been
treated with Herceptin but no longer benefit from the older drug, the
FDA said.
Generally, women with HER2 positive breast cancer face a greater risk
of disease progression and death. Approximately 8,000 to 10,000 women
die from metastatic HER2 positive breast cancer each year, the FDA
said.
Xeloda, or capecitabine, is made by Switzerland's Roche Holding AG.
South San Francisco-based Genentech Inc. makes Herceptin, also known
as trastuzumab.
Eventually, Tykerb could be studied for use with Herceptin, said Dr.
Len Lichtenfeld, deputy chief medical officer of the American Cancer
Society. And Glaxo said it's studying Tykerb as a treatment for other
cancers.
"Some of those reports have been promising and others less so. But it
is too early to know which other cancers - if any - are going to
respond to this new drug," Lichtenfeld said.
Expanded use of Tykerb eventually could make it a blockbuster drug for
Glaxo, with annual sales approaching or exceeding $1 billion, analysts
have said.
