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The Office of New Drugs (OND) recommends withdrawing approval of the breast cancer indication for bevacizumab (Avastin). This indication was approved on February 22, 2008, under accelerated approval provisions for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.
As a condition of the accelerated approval, Genentech was required to submit data from two ongoing trials (AVADO and RIBBON1) to provide verification of the treatment effect on progression- free survival (PFS) and to provide additional information on the effects on overall survival (OS). These two trials failed to confirm the magnitude of benefit originally observed in the E2100 study on which accelerated approval was based. In addition, there was an overall increase in serious adverse events related to bevacizumab.
The modest benefit observed with Avastin together with the substantial adverse reactions observed in breast cancer trials to date fail to provide a favorable risk-benefit profile to support continued marketing of Avastin for a first-line metastatic breast cancer indication. It is the conclusion of OND that the breast cancer indication for Avastin be withdrawn.
Let me get this correct. The "conservatives" whine about big govt and govt. spending, but when the govt tries to control spending they whine. It seems like they want the govt. to continue to have an open checkbook in some cases.
[quote=GreenGene;17166680]Did anyone take the time to look for and read the actual FDA decision on this? Or is everyone satisfied with someone else's interpretation?
The Office of New Drugs (OND) recommends withdrawing approval of the breast cancer indication for bevacizumab (Avastin). This indication was approved on February 22, 2008, under accelerated approval provisions for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.
As a condition of the accelerated approval, Genentech was required to submit data from two ongoing trials (AVADO and RIBBON1) to provide verification of the treatment effect on progression- free survival (PFS) and to provide additional information on the effects on overall survival (OS). These two trials failed to confirm the magnitude of benefit originally observed in the E2100 study on which accelerated approval was based. In addition, there was an overall increase in serious adverse events related to bevacizumab.
The modest benefit observed with Avastin together with the substantial adverse reactions observed in breast cancer trials to date fail to provide a favorable risk-benefit profile to support continued marketing of Avastin for a first-line metastatic breast cancer indication. It is the conclusion of OND that the breast cancer indication for Avastin be withdrawn.
Seriously these women are DYING this is funny that trials failed to provide a favorable risk-benefit This is their last chance to fight the cancer!
Seriously these women are DYING this is funny that trials failed to provide a favorable risk-benefit This is their last chance to fight the cancer!
And with the drug, they still are dying......
The main goals of therapy for breast cancer are palliation of symptoms and prolongation of overall survival time without negatively impacting quality of life. The data from the four studies concluded that women who took Avastin did not live any longer than women who did not receive the drug, and yet were at risk of experiencing severe side effects, including side effects that are unique to this drug ..........
Recently we learned that a bureaucratic group had inserted the need for end of life consultation for older people. I believe that the Dems just don't want this to be widely known but they will have trouble hiding it from "We the people" long enough to get it inserted into the law we call ObamaCare. It is a crime and a shame the way some people are using end runs around the courts and We the people. When will people tire of this crap and do something about it? When enough members of We the People make this kind of thing widely known among themselves some of this will stop.
End of life care decisions are something to be decided by an individual and his or her family. I see many lawsuits in the future from surviving family members who claim a doctor wrongfully convinced a family member to become a Do Not Resuscitate patient.
Recently we learned that a bureaucratic group had inserted the need for end of life consultation for older people. I believe that the Dems just don't want this to be widely known but they will have trouble hiding it from "We the people" long enough to get it inserted into the law we call ObamaCare. It is a crime and a shame the way some people are using end runs around the courts and We the people. When will people tire of this crap and do something about it? When enough members of We the People make this kind of thing widely known among themselves some of this will stop.
I think the greatest trick politicians ever pulled was making you think that it was Dems vs Repubs.
You fell for that one hook, line, and sinker. Do you really think that Republicans don't want to have authority over your healthcare choices? The insurance and healthcare industry are what control the medicine and end of life care you get, and they don't care if you are a Democrat or a Republican.
Almost every post you make begins or ends with "obamacare". You make it so easy for them.
Last edited by JayBrown80; 12-28-2010 at 10:44 PM..
I think the greatest trick politicians ever pulled was making you think that it was Dems vs Repubs.
You fell for that one hook, line, and sinker. Do you really think that Republicans don't want to have authority over your healthcare choices? The insurance and healthcare industry are what control the medicine and end of life care you get, and they don't care if you are a Democrat or a Republican.
Almost every post you make begins or ends with "obamacare". You make it so easy for them.
Do you think that the bureaucrats that made that attempt at an end run around a part of Obamacare that the Congress had refused to accept were Republicans? You know perfectly that they weren't but keep on throwing that crap to change the subject as it must mean something.
Do you think that the bureaucrats that made that attempt at an end run around a part of Obamacare that the Congress had refused to accept were Republicans? You know perfectly that they weren't but keep on throwing that crap to change the subject as it must mean something.
If you are honestly asking me what I think, and not just being facetious, I will tell you.
I think that it is not in the best interest of the drug industry or the insurance industry to cure disease. I think they pay a lot of money to both parties to make sure that Americans stay sick. Not just in legislation on health care, but by supressing information and also by making sure Americans pump their bodies full of poison on a daily basis.
I don't think the Republican policy towards health care is self sustaining, compassionate, or based on logic.
I think that Republicans don't care about people with diseases, or paralysis, or genetic ailments. Because they block legislation on stem cell research that has been proven to provide relief for any number of diseases and ailments.
I think Republicans are all for government intervention into personal private family medical decisions. Or do you not remember the Terry Schiavo case?
I Think that you have NO idea what socialized health care is, or how that differs from what you call "obamacare".
I don't think any human being should DIE for lack of an 80 dollar prescription.
I think that the 3 trillion dollars we have currently spent in Iraq for the last 8 years would have been enough to provide health care to every man woman and child in America for a full decade. I question the Republican policy that war is a moral imperative but that attending to the sick is not.
I question you saying I am trying to change the subject when I didn't absolve Democrats for their lack of leadership in protecting the health of America. If anything, they have been just as complicit as Republicans in making it nearly impossible for Americans to get and stay healthy. But you, you cannot see past your own political opinions. You have a "with us or against us" mentality. I am fair, b/c I can point out the failings of both political parties. I wonder what it says about you that you can't.
But then again, I do think you are being facetious.
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Political End Runs
