According to www.vision2america website the FDA decided yesterday that they were going to start rationing the Breast Cancer drug "Avistan" which over 17,500 women in the United States rely on to survive. 
Is this the beginning of Obumma's death panels?
- Thread starter Poorboy
- Start date
jujubeans
OVM Project Manager
According to Vision to America website the FDA decided yesterday that they were going to start rationing the Breast Cancer drug "Avistan" which over 17,500 women in the United States rely on to survive.
This will come up now.
greg334
Veteran Expediter
OMG, the sky is falling.
1 - the FDA made a preliminary step toward revoking the approval for treatment of Breast Cancer. THIS drug went through the fast track FDA approval system (another term is accelerated approval) which in itself is a problem with a lot of the drugs on the market and is a second line drug - not a primary drug.
2 - there is no rationing with the FDA, they do not control the access points. The insurance company is the deciding factor or the patients pocket book.
3 - because the words Breast and Cancer are involved, the pink ink comes out and start complaining. There is hope, it is one of the indications that they are looking at that they are going to revoke, not remove the drug off the market but it will be a restricted drug unless the doctors are willing to help out with the big issue of insurance.
4 - this really hurts Roche because they targeted Breast Cancer patients with the $7700 a month treatment and are selling about 20,000 treatments a month.
5 - the FDA, like the DHH and other agencies need to be revamped from the ground up. There is no reason that a Cancer patient should be refused any experimental drugs for any reason.
6 - it is not the end of the world.
1 - the FDA made a preliminary step toward revoking the approval for treatment of Breast Cancer. THIS drug went through the fast track FDA approval system (another term is accelerated approval) which in itself is a problem with a lot of the drugs on the market and is a second line drug - not a primary drug.
2 - there is no rationing with the FDA, they do not control the access points. The insurance company is the deciding factor or the patients pocket book.
3 - because the words Breast and Cancer are involved, the pink ink comes out and start complaining. There is hope, it is one of the indications that they are looking at that they are going to revoke, not remove the drug off the market but it will be a restricted drug unless the doctors are willing to help out with the big issue of insurance.
4 - this really hurts Roche because they targeted Breast Cancer patients with the $7700 a month treatment and are selling about 20,000 treatments a month.
5 - the FDA, like the DHH and other agencies need to be revamped from the ground up. There is no reason that a Cancer patient should be refused any experimental drugs for any reason.
6 - it is not the end of the world.
witness23
Veteran Expediter
LOL......Okay, so I click your link, which doesn't work by the way, so I google it. The address is visiontoamerica.org. I read the story and I'm like, this is it, there has got to be more? I then notice the "Source: Click Here for Full Story" button. I click that, and lo' and behold, it takes me to Andrew Breitbarts "Big Government" website. That's funny.
3 questions:
1. Did you click the "Click here for Full Story" button?
2. If you did, did you read the article that was written by "Capitol Confidential"? some might ask themselves, who is "Capitol Confidential"? From Breitbarts site:
3. Did you happen to check out any other news articles about this story? If so, who were they?
3 questions:
1. Did you click the "Click here for Full Story" button?
2. If you did, did you read the article that was written by "Capitol Confidential"? some might ask themselves, who is "Capitol Confidential"? From Breitbarts site:
3. Did you happen to check out any other news articles about this story? If so, who were they?
witness23
Veteran Expediter
One other question. Have you, poorboy , experianced the effects of cancer first hand? I mean, up close and personal, making decisions for a loved one to make them comfortable or discussing choice of treatments with an oncologist, or the decision to contact Hospice, or getting "end of life" counseling? Any of those?
witness23
Veteran Expediter
Why is it bad?
witness23
Veteran Expediter
I guess it doesn't greg. <sarcasm> I guess we shouldn't question the reason why someone starts a thread with: Is this the beginning of Obumma's death panels? and then follows that up with: FDA decided yesterday that they were going to start rationing the Breast Cancer drug "Avistan". With such argumentitive language we shouldn't ask ourselves what this persons motives are.
I guess just reading a snippet of a news story who's source happens to be Big Government is good enough to get the whole story about this matter.
I'm sure its his concern over the recipients of this drug, and has nothing to do with his disdain for the President or this administration.
greg334
Veteran Expediter
Well I see it as a concern more than it is anything else. The FDA and other agencies are handed too much power to regulate not just drugs but food, which in itself could be construed as a death panel.
One example of the FDA's need to regulate is Stevia, which is a sweetener derived from a plant leaf. The FDA under the Bush I adminstration made the move to ban the use of Stevia and it's derivitives as a food additive, which went against their own policies for different reasons with a lot of facts surrounding this decision was solely made on behalf of the artificial sweetener industry. The WHO, a group that actually tested the sweetener, found nothing wrong with it nor causes cancer which was the basis for the FDA ban.
One example of the FDA's need to regulate is Stevia, which is a sweetener derived from a plant leaf. The FDA under the Bush I adminstration made the move to ban the use of Stevia and it's derivitives as a food additive, which went against their own policies for different reasons with a lot of facts surrounding this decision was solely made on behalf of the artificial sweetener industry. The WHO, a group that actually tested the sweetener, found nothing wrong with it nor causes cancer which was the basis for the FDA ban.
As a Matter of fact I HAVE EXPERIENCED IT FIRST HAND UP CLOSE AND PERSONAL! I Lost my wife to it and I don't take anything involving cancer too lightly! You might, but I Don't, So if you want to Knit pick me on this then you go Right ahead if it makes you feel so superior as I had already expected "Some" of you to anyway!
All I wanted to do was to make people aware of the article and if you can't understand that then I feel sorry for you!
greg334
Veteran Expediter
Sorry for your loss, I know how you feel, I have to deal with a loved one and their battle right now.
The one thing that frustrates me is the lack of options to use drugs that are in the phase three (human) trials or entering them. If the access for the patients was available, then maybe we can see better treatments.
About this subject, it is serious but many listen to the media, like ABC and CNN, and get this idea that it is the end of treatment. Even with an emotional subject, ABC was trying to interview people who were under treatment and they made it out like they were going to be cut off today. It was frustrating to listen to it.
The one thing that frustrates me is the lack of options to use drugs that are in the phase three (human) trials or entering them. If the access for the patients was available, then maybe we can see better treatments.
About this subject, it is serious but many listen to the media, like ABC and CNN, and get this idea that it is the end of treatment. Even with an emotional subject, ABC was trying to interview people who were under treatment and they made it out like they were going to be cut off today. It was frustrating to listen to it.
A bit of a different take on this from the WSJ (emphasis mine):
"The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren't any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency-the FDA's counterpart in the European Union-decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network-a consortium of 21 leading cancer centers that issues evidence-based medical guidelines-reaffirmed its position that Avastin is valuable in some cases...
The FDA's assault will make it harder to conduct and enroll patients in further clinical studies, to say nothing of its message about the regulatory risk for drugs still in development."
Breast Cancer Topic: Avastin Editorial from The Wall Street Journal
The last sentence sums up the problem quite well. Think what it will be like if ObamaCare does become a reality, then starts going broke after only a few years.
"The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren't any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency-the FDA's counterpart in the European Union-decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network-a consortium of 21 leading cancer centers that issues evidence-based medical guidelines-reaffirmed its position that Avastin is valuable in some cases...
The FDA's assault will make it harder to conduct and enroll patients in further clinical studies, to say nothing of its message about the regulatory risk for drugs still in development."
Breast Cancer Topic: Avastin Editorial from The Wall Street Journal
The last sentence sums up the problem quite well. Think what it will be like if ObamaCare does become a reality, then starts going broke after only a few years.
greg334
Veteran Expediter
Clinical trails unless done by the HHS, NIH or a university are funded by the company directly and controlled by the company with the permission of the FDA once the application for development studies are approved. The FDA or the feds don't do a selection of patients, that is a protocol of the study which is approved by the FDA.
It goes right back to the issue of the FDA and what I said, it is the problem when patients, especially terminal ones can't get drugs to try out.
The drug in question was fast tracked based on one study, further studies are in process and this is where they came to the conclusion. The fast tracking process is really flawed, there is no need to restrict the drug study while moving it through the system in half the time other than to lengthen the patent life.
It goes right back to the issue of the FDA and what I said, it is the problem when patients, especially terminal ones can't get drugs to try out.
The drug in question was fast tracked based on one study, further studies are in process and this is where they came to the conclusion. The fast tracking process is really flawed, there is no need to restrict the drug study while moving it through the system in half the time other than to lengthen the patent life.
witness23
Veteran Expediter
As a Matter of fact I HAVE EXPERIENCED IT FIRST HAND UP CLOSE AND PERSONAL! I Lost my wife to it and I don't take anything involving cancer too lightly! You might, but I Don't, So if you want to Knit pick me on this then you go Right ahead if it makes you feel so superior as I had already expected "Some" of you to anyway!
All I wanted to do was to make people aware of the article and if you can't understand that then I feel sorry for you!
I am truly sorry about your wife. I am also sorry that you, your family and loved ones had to suffer through the experiance of a loved one fighting the battle of cancer.
I have gone through the battle of cancer twice in my young life, first with my father in '96, then my mother two years ago. Both had been diagnosed with small cell carcinoma of the lungs. My father lasted a year after his diagnosis and my mother lasted 2 years. From diagnosis to those final days, it is nothing short of a roller coaster of emotions and events. To being by their sides during chemo treatments and trying to make them laugh, to taking care of them because of the side effects from the treatments, to picking out wigs from a catalog, to the hundreds of doctor appointments, the hundreds and hundreds of miles traveling to see doctors and experts, the countless hours spent reading about the cancer and its treatments, the emergency room visits when they were to sick for me or other family members to care of them, the conversations with siblings to see what's best for mom and dad, the good days when you could get outside with them and enjoy nature and each other’s company, we cherished the days we could go out to eat and those days my mom could muster up enough strength to cook dinner for us, the days I would take my dad to the golf course just to ride in the cart and watch me play, to the days where you had to feed them, change them, communicate for them, clean them up when they couldn't keep their food down. Then talking to the doctors about clinical trials and if your loved one was a candidate for such trials going on. Getting on a clinical trial and the hope everyone felt then the disappointment when the trial didn't help. Then the blessings of Hospice and the people that run that organization and the talks of end of life planning and getting everything in order so that my parents didn't have to worry about us after they were gone. Then, myself having the unfortunate or fortunate experience of being by my father's and mother's side and hearing the escape of their last breath before they left this earth to be with our God in heaven.
So as you can see I have been through cancers harsh experiences and the rare joys that it can bring. I also take things such as death panels and the approval of drugs and clinical trials and the effectiveness of certain procedures, and choices that have to be made by many of people seriously. This is not a subject that should be taken lightly by anyone. Even if you have been fortunate enough, not to have experienced cancer in your family, you more than likely will eventually. When talking of matters such as this, one would hope due diligence has been done before commenting on it and not being used for political purposes or to further someone’s agenda.
Yeah, I remember all of that and NONE of it was a very happy moment for either of us. Especially all of the Drs. appointments to several different Drs.(One that sticks out was that One Dr.refused to even treat her because he thought that she was only after prescription Pain Killers) I guess because of her young age(34) at the time when all of this started so he sent her (Us) elsewhere. This went on for over 6 years until she passed away. She turned 40 in October and passed away 6 months later on April 24th. That's memory you never forget.
This was Not for any Political agenda I assure you! It's true, I don't like the current occupant of the White house because he is not competent to be there and I make no bones about it. But I only posted this so others who are affected by cancer would know about it!
My wife was being treated for a stomach Ulcer even after many many stomach scopes were done, the so called Dr. never suspected cancer? Even though he couldn't find the ulcer until on one hospital stay(of many) an intern who was studying to be a surgeon suggested that a biopsy wouldn't hurt as long as they were in her stomach as he was surprised of the amount of Undigested food that she had eaten on Thanksgiving was still in her stomach (and this was in January when they did the scope) They took a large enough sample of her stomach and sent it to the hospitals Pathologist who in turn sent the sample to the Mayo clinic (I think in Minnesota) and it came back positive for cancer. By then it was too late as the cancer had spread to the Pancreas and other organs. A cancer specialist was called in and performed the surgeries but it was too late by then. So she suffered for months and never left the hospital alive and eventually I had to sign a DNR just in case she was to be put on life support as that is what she told me that she wanted.
This was Not for any Political agenda I assure you! It's true, I don't like the current occupant of the White house because he is not competent to be there and I make no bones about it. But I only posted this so others who are affected by cancer would know about it!
My wife was being treated for a stomach Ulcer even after many many stomach scopes were done, the so called Dr. never suspected cancer? Even though he couldn't find the ulcer until on one hospital stay(of many) an intern who was studying to be a surgeon suggested that a biopsy wouldn't hurt as long as they were in her stomach as he was surprised of the amount of Undigested food that she had eaten on Thanksgiving was still in her stomach (and this was in January when they did the scope) They took a large enough sample of her stomach and sent it to the hospitals Pathologist who in turn sent the sample to the Mayo clinic (I think in Minnesota) and it came back positive for cancer. By then it was too late as the cancer had spread to the Pancreas and other organs. A cancer specialist was called in and performed the surgeries but it was too late by then. So she suffered for months and never left the hospital alive and eventually I had to sign a DNR just in case she was to be put on life support as that is what she told me that she wanted.
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