Skip to comments.FDA's Avastin decision is a breast cancer patient's worst nightmare
Posted on 12/26/2010 6:40:22 PM PST by gusopol3
ronically, the exact same day the FDA revoked Avastin's approval, its counterpart across the Atlantic did the opposite. The European Union's Committee for Medicinal Products for Human Use had conducted a similar investigation into Avastin in breast cancer treatment...
Genentech, Avastin's developer, spent some $2.3 billion creating this treatment. In reaction to this decision, other drug firms will be less likely to make the investments required for research into advanced drugs.
(Excerpt) Read more at washingtonexaminer.com ...
This is exactly the way this administration will ration. They will 1) slow the approval or prevent the approval of new treatments that could increase medical expenses, and 2) shift research funding from basic science to ‘outcomes’ statistical research, and ‘health care delivery’ research.
Then they could use all that money they confiscated in the name of health care on more important things!
The FDA should be abolished.
All of its useful functions can be performed better by the free market.
And yet on TV we hear these poignant ads about trying to cure this disease and that disease showing pathetic kids with that particular disease. Why should pharmaceutical companies invest billions to try to find a cure when the FDA comes around later to stop it.
“This is what a death panel is all about, in my opinion”
Should cost be part of medical decisions?
Sure. But, as I see it, the relevant question here is whether the cost/benefit decision should be made on behalf of all individuals by a small group of government bureaucrats.
Cost-effectiveness always has been to some degree, but if it costs 2.4 billion to develop a drug, how else are you going to get medical improvements but to spread the cost through insurance?
“Should cost be part of medical decisions?”
Between a doctor and a patient,,but this is the FDA deciding it’s too expensive to be used. Their only scope should be to clearly know it’s effects. It isn’t their place to decide price.
“Sure. But, as I see it, the relevant question here is whether the cost/benefit decision should be made on behalf of all individuals by a small group of government bureaucrats.”
Who pays, and is the cost relevant? That is really the question.
Hammer, meet Nail. It floors me to think that some so-called "conservatives" here on FR seemingly back Obama's DEATH PANELS in the name of "cost benefit" analysis or some goofy "actuarial" mumbo-jumbo.
Obama Death Panels by any other name are still Obama Death Panels.
“how else are you going to get medical improvements but to spread the cost through insurance?”
Insurance isn’t for new, expensive treatments.
I assume you're alluding to a system of third-party payers (including insurance companies and/or the government) where the cost becomes relevant to more than the individual receiving the benefit?
If so, as you suggest, decisions like these are the inevitable result of government involvement as a payer of healthcare costs. And the further result of this decision can be nothing other then to have a chilling effect on further innovation within the lifescience sector.
I suppose the next question is, what then is the answer? In my opinion, policy should be to more directly align the cost and benefit received. Reintroduce the free market into this space.
“Their only scope should be to clearly know its effects. It isnt their place to decide price.”
I agree. This is being used as a bureaucratic tool to deny patients who may get a few months of extra life.
But the question still stands - is cost relevant, especially if the patient is unable or unwilling to pay for it themselves? If you really wanted it, you can fly to Europe and get it - but you’d have to pay for it.
So is cost relevant to treatments available to patients?
“I assume you’re alluding to a system of third-party payers (including insurance companies and/or the government) where the cost becomes relevant to more than the individual receiving the benefit? “
I am wondering about both. Can insurance companies provide coverage for treatments that reach $100k per year to extend life a few months and still provide affordable coverage? Also, if the individual receiving the drug had to pay for it, would they?
I think most of the argument is actually financial, rather than medical. The result may be the same - treatment denied, but it’s not the same as a death panel - where treatment may be given to one, but not another.
“I suppose the next question is, what then is the answer? In my opinion, policy should be to more directly align the cost and benefit received. Reintroduce the free market into this space.”
I suppose if it is not a dangerous treatment, and someone was willing to pay for it, it should be made available. Since the FDA realizes that “the rich” would pay for it they are reacting to a defacto socialist mandate - if everybody can’t have it, for whatever reason, nobody can have it.
Granted, that has no direct bearing on expensive treatments such as Avastin. But I do believe that the free market will sort that out in the form of various insurance plans based on what an individual would like to have covered. No system is perfect, but this FDA decision is the obvious end result of allowing government to pay healthcare costs.
The result may be the same - treatment denied, but its not the same as a death panel - where treatment may be given to one, but not another.
It's a good point. From a practical standpoint, the end result may not differ in more than a very few cases. That said (call me an absolutist), if an individual or the market makes that decision it's totally different than when the government makes it. I suspect we agree on that as well.
If Avastin were for AIDS, we wouldn’t be having this conversation.
I think it's pretty well-established that, no matter their credentials, they made the decision based on cost-benefit as opposed to risk-benefit analysis.
Call 'em what you will, we need to have controls on what public funds are spent on.
And that's exactly why people should be fighting against any government involvement in healthcare. If public funds were not being spent, the control would be left to the free market (where it belongs).
“I suspect we agree on that as well.”
I think I understand what is bugging me about this. The FDA is trying to put a veneer of science on a decision that supports socialism. I think that expensive treatments like this cannot be provided to everyone without regard to cost - but to make illegal simply because there is a chance someone may be willing pay for it and get it, and that there will be many who want it, but can’t pay for it - so take off the political heat by revoking approval for anyone.....this pretends to be science when it is really barely masked class envy.
That is a very good point; kudos for making it.
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Thank you for walking me through the point. I think it’s an important one.
Yes. The death panels begin with whimper as Big Media ignores the Socialist Government that is the decider between life and death. And you know they won’t be deciding death for other Socialists, but those who disagree with their Socialist Government. Just like the ‘Stimulus’ money. Everything for the Socialists and nothing for anyone else.
Pleasure chatting with you...if only all threads were this “nonconfrontational”! Off to bed so I can get up and shovel tomorrow AM. Have a good one.
No, see, this is the brilliance of Obamacare. The GOVERNMENT makes the decision, not you, not your doctor. See how that works? Isn’t it just effing brilliant? It is going to work out just super. And all of us were just so wrong about how awful this was going to be. We just hated it because Barack is black and the democrats passed it without reading it or getting any republican votes.
Got that right. Barney Butt-Pucker would be screaming so loud about that, you’d think his boyfriend had stuffed a football up his pooper.
The problem is today, health insruance is not “insurance”.
Insurance covers the unexpected, the accidents, catastrophic stuff. Not regular preventative stuff. Not necessarily chronic stuff. They really aren’t insurance as we’ve known what traditional insurance is, it’s more “health supplemental plans” or “healthcare cost coverage” plans, or “health benefits plans”.
People want certain levels of coverage. Knowing they will use the plans. Pregnancy. Sicknesses. Emergencies. Accidents. Routine care. Checkups. Vision issues. Wellness tests. Colonoscopies. Whatever. People expect to use health insurance. So it’s really a benefits plan more than insurance. Nobody knows if their house will ever be destroyed. Or when. Nobody knows if they ever will get into a big car accident, or kill someone while driving. Everybody buys health benefit plans with the expectation they will be using them under one or more scenarios in their future.
The ONLY thing that should require a prescription is where the public health is threatened (e.g., to prevent overuse of antibiotics, which allows an individual to spread drug-resistant pathogens).
The FDA already hates me but I don't care. They killed a friend of mine, so the feeling is mutual.
I wonder how many people the FDA has killed with their irresponsible drug decisions.
First Avastin, then a thousand other drugs and treatments. If you look at other cancer or auto-immune or stem-cell or bone marrow treatments, you will realize that many, many of them are just as expensive as Avastin. This is only the beginning. Soon the feds will only allow for the dispensing of aspirin, maalox, and hemorrhoid medications. That is what our arsenal will be whittled down to. They will force all R&D to stop and the drug companies will go the way of the vaccine makers. Every new medicine is very expensive in the beginning, then the drug companies usually reduce the cost and let their patent run out. Right now we are being threatened by a new bacterium that is completely resistant to any and all antibiotics. Do you think big pharma is going to invest billions to create a new silver bullet, just to be squashed by our FDA? We might as well go back to bleeding our patients, as that is cheap and will most likely be the only therapeutic approved by our FDA.
They need to spend less money on research and more on lobbyists, obviously!
The FDA has been doing this for decades—it’s not just Obamacare driving this. It’s also the overly litigious society.
There’s no sanction against them when they overreact, so naturally they use their power and cover their assets whenever it comes to it. A simple announcement is all thast’s needed sometimes—not even a warning—and the thing is pulled from the shelf because of the lawsuit threat. The phenylpropanolamine (PPA) fiasco was like that.
You can look to see more such costly drugs pulled in the future. And drug companies doing LESS research.
Obama Returns to End-of-Life Plan That Caused Stir http://www.nytimes.com/2010/12/26/us/politics/26death.html
They don’t even do that...take Lyrica for example the severe side effects hit very high percentage who try to take it.
Pretty poor track record, yet is is approved for treating Peripheral Neuropathy in diabetics and Fibromyalgia. BTW Peripheral Neuropathy is NOT always diabetic cause. Those of us with Fibromyalgia get it too.
Exactly right. And because government involvement is so pervasive, the government's decisions can lead to potentially valuable research's being completely shut down, never even begun.
I have NO confidence in any of these chemo treatments and I will never do it.
I will try natural therapies first and if that doesn't work, too bad, I'm gonna die some day anyway.
I've seen people put their trust in this chemo thing and their lives have become hell and then they die anyway. Count me out.
I have a friend with ovarian cancer who has done none of the recommended therapies and is still alive using only natural therapies after at least two years. She's in a heck of a lot better shape than if she had done chemo.
Just wait ‘till they start banning treatments for CF or “Jerry’s Kids”! Michael J Fox’s “stem cell treatments” will get banned as well....a lot of famous libs pet oxen are about to get gored.
A lot of Aids treatments have similar toxic side effects and questionable value for extending life...wait until statistical analysis starts to be applied to them as well! Bono from U2 will go into apoplexy!