A Step Closer to Death Panels

[boedicca]

Federal Health Authorities are expected to prevail in getting the FDA to unapprove Avastan (an $80K per year drug) for breast cancer patients.

And recall the position on reducing the use of mammograms some months ago. It's quite clear that the Feds are intent on reducing access to "expensive" procedures and drugs. In this case, the FDA is the means to reduce treatment.

Despite all evidence to the contrary, the advisory committee claims its recommendation had nothing to do with Avastin's cost. The FDA's top brass will doubtlessly take the same line and claim that its decision to ratify that recommendation was based solely on the drug's medical efficiency.

The truth is that Avastin is expensive. A year-long supply for breast cancer treatment costs upwards of $80,000.

However, many American women are getting something priceless in return for those dollars: life and vitality. In one clinical trial, nearly 50% of patients receiving Avastin witnessed their tumors shrink. Another study found that patients receiving the drug in conjunction with chemotherapy lived "progression-free" twice as long as patients without it.

What's more, for a select group of "super responders," Avastin can improve life span by years. That can mean years of extra time for, say, a mother to attend her son's soccer games, for a daughter to vacation with her husband, or for a grandmother to watch her grandchildren grow up. ...

The Fatal Move From The FDA - Forbes.com

 

[BlindBoo]

I don't know enough about Avastan, but I will find out......

On the mammograms however.....

Federal panel recommends reducing number of mammograms - washingtonpost.com

Petitti stressed that the task force is not recommending against mammography, but that it hopes the new guidelines will lead more women to make their decisions based on their personal circumstances.

Those at high risk because of a family history of breast cancer, for example, or those who are simply more worried about the disease might still opt to have annual screenings, she said.

 

[RDD_1210]

So let's hear your viewpoint. Let's say that Avastin DOES help cancer patients but is VERY expensive. Do you think the drug should still be permitted to be used regardless of what it costs?

 

[PoliticalChic]

I don't know enough about Avastan, but I will find out......

On the mammograms however.....

Federal panel recommends reducing number of mammograms - washingtonpost.com

Petitti stressed that the task force is not recommending against mammography, but that it hopes the new guidelines will lead more women to make their decisions based on their personal circumstances.

Those at high risk because of a family history of breast cancer, for example, or those who are simply more worried about the disease might still opt to have annual screenings, she said.

"US breast cancer drug decision 'marks start of death panels'
A decision to rescind endorsement of the drug would reignite the highly charged debate over US health care reform and how much the state should spend on new and expensive treatments.

Avastin, the world’s best selling cancer drug, is primarily used to treat colon cancer and was approved by the US Food and Drug Administration in 2008 for use on women with breast cancer that has spread.

The drug was initially approved after a study found that, by preventing blood flow to tumours, it extended the amount of time until the disease worsened by more than five months. However, two new studies have shown that the drug may not even extend life by an extra month.

The FDA advisory panel has now voted 12-1 to drop the endorsement for breast cancer treatment. The panel unusually cited "effectiveness" grounds for the decision. But it has been claimed that "cost effectiveness" was the real reason ahead of reforms in which the government will extend health insurance to the poorest.

The Avastin recommendation led to revived allegations that President Barack Obama’s overhaul of the US health care system would mean many would be denied treatments currently available."
US breast cancer drug decision 'marks start of death panels' - Telegraph

 

[Intense]

The more the Fed will need to pay out in costs, the more desperate, it will be in finding excuses not to.

 

[boedicca]

So let's hear your viewpoint. Let's say that Avastin DOES help cancer patients but is VERY expensive. Do you think the drug should still be permitted to be used regardless of what it costs?

Yes. If the drug is effective, then it is up to the patient and his or her doctor to decide if it is to be part of the treatment protocol.

It certainly is not the business of a few bureaucrats in DC to decide.

Other things in life are expensive: homes, cars, vacations. Why should it be anybody else's business what we decide to purchase?

 

[boedicca]

The more the Fed will need to pay out in costs, the more desperate, it will be in finding excuses not to.

I expect this is the first in long train of FDA Unapprovals.

Afterall, Obama said that all we need is aspirin. And that's all that will be left on the approved list for the little people. The Politically Connected Elite will still have access to these medicines.

 

[xotoxi]

The FDA did not factor the cost of the medication into their decision.

The data presented to the committee apparently showed that for these patients, in this more current analysis, the drug delayed progression of their breast cancer by 5.5 months. The women who took Avastin in addition to the chemotherapy went 11.3 months before their disease progressed compared to 5.8 months for women who took only the chemotherapy.

But the Avastin group also had more side effects, including 6 deaths attributed to Avastin treatment, or 1.7% of the women who participated in the study.

The key determining factor, according to press reports, was that the women who received Avastin did not live significantly longer than women who did not receive it. And, this is considered an important statistic.

No prolonged survival, no approval.

Avastin And Breast Cancer: It's Not Over Yet

If the same results were found with aspirin therapy, the FDA would not have approved aspirin for treatment of breast cancer...even though the treatment cost would have been pocket change.

 

[PoliticalChic]

The more the Fed will need to pay out in costs, the more desperate, it will be in finding excuses not to.

I expect this is the first in long train of FDA Unapprovals.

Afterall, Obama said that all we need is aspirin. And that's all that will be left on the approved list for the little people. The Politically Connected Elite will still have access to these medicines.

We should be very careful as to whom we give power of life and death:

"No one should subscribe to the reasoning of a bioethicist, even one as eminent as Dr Emanuel, without kicking the tyres. He should be asked two questions: what makes us human and what makes right right and wrong wrong. If we can agree on the philosophical bits, it is much more likely that we will agree on the practical consequences which flow from them.

Let's say that your mother has Alzheimer's and breaks her hip. Let's say that all the bioethicists on the hospital ethics committee have degrees in behavioral economics, psychology, decision theory or sociology. Would you find that reassuring? When tough decisions have to be made about her future, would you expect them to treat your mother as a unique human being with inalienable dignity? Probably not. Probably the thought would cross your mind that these guys may know a lot about quality-adjusted life years, but not a lot about how precious a human life is. In fact, the thought might cross your mind that this looks more like a death panel than an ethics committee.

No doubt the ASBH would respond, “Trust us! We are honourable men. Decent people like us would never ignore your mother's dignity.” Hopefully this is true of most members of the ASBH. But “trust us” is not a very persuasive argument.”
http://www.mercatornet.com/articles/view/death_panel_dudgeon/
(emphasis mine)

 

[boedicca]

The FDA did not factor the cost of the medication into their decision.

The data presented to the committee apparently showed that for these patients, in this more current analysis, the drug delayed progression of their breast cancer by 5.5 months. The women who took Avastin in addition to the chemotherapy went 11.3 months before their disease progressed compared to 5.8 months for women who took only the chemotherapy.

But the Avastin group also had more side effects, including 6 deaths attributed to Avastin treatment, or 1.7% of the women who participated in the study.

The key determining factor, according to press reports, was that the women who received Avastin did not live significantly longer than women who did not receive it. And, this is considered an important statistic.

No prolonged survival, no approval.

Avastin And Breast Cancer: It's Not Over Yet

If the same results were found with aspirin therapy, the FDA would not have approved aspirin for treatment of breast cancer...even though the treatment cost would have been pocket change.

The FDA had already approved Avastin - this is a reversal of prior approval - and highly suspect.

If someone wishes to take the risk in order to gain a few extra months of life - that is none of the government's business.

We're going to see more of this.

 

[xotoxi]

The Politically Connected Elite will still have access to these medicines.

Anyone that wants to pay cash for these medications will have access to these medications...as long as they accept the risk of deadly side-effect and understand that they are not going to live any long than if they didn't take the medicine.

 

[RDD_1210]

So let's hear your viewpoint. Let's say that Avastin DOES help cancer patients but is VERY expensive. Do you think the drug should still be permitted to be used regardless of what it costs?

Yes. If the drug is effective, then it is up to the patient and his or her doctor to decide if it is to be part of the treatment protocol.

It certainly is not the business of a few bureaucrats in DC to decide.

Other things in life are expensive: homes, cars, vacations. Why should it be anybody else's business what we decide to purchase?

Interesting because it's the insurance companies will be the ones paying for this. Which means that cost gets passed to everyone else through higher premiums. Now "your choice" is affecting me. Aren't you one of the ones who argues about "paying your own way and not mooching off of everyone else"? This seems like an awfully expensive drug to be using when it isn't proven to be completely effective, especially for a fiscal hawk such as yourself.

Now I'm not saying it should have its approval taken away, at least not for cost reasons. I don't think cost should be a primary factor when considering peoples health, but if the data isn't there to support it being effective then that's a different story.

 

[Gadawg73]

Big Pharma are very good at initial claims. No doubt this drug is effective but HOW effective?
Time line claims are always weighted to the long term side versus the median.
Namenda was first heralded as helping with memory loss for dementia and early stages of Alzheimers. Now the claims, after FDA pressure, are that NAMENDA does nothing to help memory loss other than slow the progression of the disease. However, most of the people that take it and their families still believe that it will help their family member regain some memory.
In an era of 89 year olds receiving hip replacements at 75K per while 40% of the entire budget is borrowed, with Medicare and Gramps and Grannies Dope Plan the fastest growing part of the federal budget, it is quite foolish NOT to question costs of all medical procedures and drugs.

 

[xotoxi]

The FDA did not factor the cost of the medication into their decision.

The data presented to the committee apparently showed that for these patients, in this more current analysis, the drug delayed progression of their breast cancer by 5.5 months. The women who took Avastin in addition to the chemotherapy went 11.3 months before their disease progressed compared to 5.8 months for women who took only the chemotherapy.

But the Avastin group also had more side effects, including 6 deaths attributed to Avastin treatment, or 1.7% of the women who participated in the study.

The key determining factor, according to press reports, was that the women who received Avastin did not live significantly longer than women who did not receive it. And, this is considered an important statistic.

No prolonged survival, no approval.

Avastin And Breast Cancer: It's Not Over Yet

If the same results were found with aspirin therapy, the FDA would not have approved aspirin for treatment of breast cancer...even though the treatment cost would have been pocket change.

The FDA had already approved Avastin - this is a reversal of prior approval - and highly suspect.

If someone wishes to take the risk in order to gain a few extra months of life - that is none of the government's business.

We're going to see more of this.

Cancer drugs are given approval very early with very little data. If they went through the normal approval process, they would take years and very few would be approved due to serious side-effects.

As for gaining a few extra months of life, they didn't live any longer.

 

[boedicca]

So let's hear your viewpoint. Let's say that Avastin DOES help cancer patients but is VERY expensive. Do you think the drug should still be permitted to be used regardless of what it costs?

Yes. If the drug is effective, then it is up to the patient and his or her doctor to decide if it is to be part of the treatment protocol.

It certainly is not the business of a few bureaucrats in DC to decide.

Other things in life are expensive: homes, cars, vacations. Why should it be anybody else's business what we decide to purchase?

Interesting because it's the insurance companies will be the ones paying for this. Which means that cost gets passed to everyone else through higher premiums. Now "your choice" is affecting me. Aren't you one of the ones who argues about "paying your own way and not mooching off of everyone else"? This seems like an awfully expensive drug to be using when it isn't proven to be completely effective, especially for a fiscal hawk such as yourself.

Now I'm not saying it should have its approval taken away, at least not for cost reasons. I don't think cost should be a primary factor when considering peoples health, but if the data isn't there to support it being effective then that's a different story.

That's what insurance is - pooled risk. If I want to purchase insurance coverage which includes Avastin as an approved med, I should be able to - just as you should be free to purchase insurance coverage which doesn't. If there is enough demand for both options, then the insurance companies can price them accordingly.

The ObamaCare you support will get rid of any choice regarding coverage whatsoever.

 

[RDD_1210]

Yes. If the drug is effective, then it is up to the patient and his or her doctor to decide if it is to be part of the treatment protocol.

It certainly is not the business of a few bureaucrats in DC to decide.

Other things in life are expensive: homes, cars, vacations. Why should it be anybody else's business what we decide to purchase?

Interesting because it's the insurance companies will be the ones paying for this. Which means that cost gets passed to everyone else through higher premiums. Now "your choice" is affecting me. Aren't you one of the ones who argues about "paying your own way and not mooching off of everyone else"? This seems like an awfully expensive drug to be using when it isn't proven to be completely effective, especially for a fiscal hawk such as yourself.

Now I'm not saying it should have its approval taken away, at least not for cost reasons. I don't think cost should be a primary factor when considering peoples health, but if the data isn't there to support it being effective then that's a different story.

That's what insurance is - pooled risk. If I want to purchase insurance coverage which includes Avastin as an approved med, I should be able to - just as you should be free to purchase insurance coverage which doesn't. If there is enough demand for both options, then the insurance companies can price them accordingly.

The ObamaCare you support will get rid of any choice regarding coverage whatsoever.

I'm just using the "logic" of the right here. I'm fully aware that it's pooled risk. But why should YOU get to have an $80k cancer drug that may or may not help you and the rest of us have to pay for it through increased rates when we don't need the drug??? </end right wing logic>

The status quo health care system you support already has death panels in place at every insurance company. Don't be dumb.

 

[boedicca]

Because health insurance is currently voluntary; and yes insurance companies make decisions on what to cover. But they don't have the power to take away all choice in the marketplace.

A great many things are expensive: open heart surgery, knee replacement, dialysis....

Instead of fostering a climate in which the insurance market can provide a variety of plans to suit a variety of preferences, you'd rather have the government decide How Much A Life Is Worth.

No thank you.

 

[Gadawg73]

Yes. If the drug is effective, then it is up to the patient and his or her doctor to decide if it is to be part of the treatment protocol.

It certainly is not the business of a few bureaucrats in DC to decide.

Other things in life are expensive: homes, cars, vacations. Why should it be anybody else's business what we decide to purchase?

Interesting because it's the insurance companies will be the ones paying for this. Which means that cost gets passed to everyone else through higher premiums. Now "your choice" is affecting me. Aren't you one of the ones who argues about "paying your own way and not mooching off of everyone else"? This seems like an awfully expensive drug to be using when it isn't proven to be completely effective, especially for a fiscal hawk such as yourself.

Now I'm not saying it should have its approval taken away, at least not for cost reasons. I don't think cost should be a primary factor when considering peoples health, but if the data isn't there to support it being effective then that's a different story.

That's what insurance is - pooled risk. If I want to purchase insurance coverage which includes Avastin as an approved med, I should be able to - just as you should be free to purchase insurance coverage which doesn't. If there is enough demand for both options, then the insurance companies can price them accordingly.

The ObamaCare you support will get rid of any choice regarding coverage whatsoever.

I agree with all of that except the last sentence.
Where is that in the bill?

 

[RDD_1210]

Because health insurance is currently voluntary; and yes insurance companies make decisions on what to cover. But they don't have the power to take away all choice in the marketplace.

A great many things are expensive: open heart surgery, knee replacement, dialysis....

Instead of fostering a climate in which the insurance market can provide a variety of plans to suit a variety of preferences, you'd rather have the government decide How Much A Life Is Worth.

No thank you.

The government isn't banning Avastin all-together. If you want it, you can go buy it for whatever purpose you want. Where is the problem?

 

[Mr. Shaman]

A Step Closer to Death Panels

A step, CLOSER????

You (quite) obviously haven't heard-about the Wicked Bitch Of The West, who's already got a Death Panel; up-and-running!!

You & Sister Sarah really stay current on U.S. news, don't you?