ObamaCare: The Government’s Rationing Toolbox Exposed
by Capitol ConfidentialThe FDA attempt to de-label Avastin for breast cancer patients is the first skirmish of the rationing wars. The battle must be fought and won. This isn’t an issue of government paying the cost of these late stage drugs. This is an issue of the government manipulating data to deny care to late stage cancer patients—even those with private insurance.
The issue at hand is whether or not the drug Avastin should be used to treat late stage terminal cancer patients. The FDA is seeking to de-label Avastin for breast cancer patients. Labeling is the FDA’s method of approval for using certain drugs for certain illnesses. Like Medicare, private insurance companies use these labels to determine whether or not they will cover the use of that drug to treat a certain illness.
Fair enough, right? But what’s particularly scurrilous about the FDA’s attempted actions with Avastin is not that they are attempting to de-label it for use with late stage breast cancer patients its how and why they are doing it.
Standard practice for evaluating drugs is to use data-driven objective endpoints to evaluate effectiveness and safety. In the case of Avastin, the FDA has arbitrarily and unilaterally stopped using this objective criterion and are applying a highly subjective criterion of “clinically meaningful”—to cut costs.
No one disputes that the drug helps extends life for terminal patients. The FDA is arguing that it just doesn’t do it for long enough to be worth the cost. So now the FDA is deciding how much life is “meaningful” and what it is worth? This should be a decision for patients, doctors and family members and the FDA should not be replacing their own value judgments about how much time is ‘meaningful’. While six months might not be significant to a statistician or a bureaucrat, for the families of a loved one or a dying patient, it’s a lifetime.
As tragic as it is for breast cancer patients today, this arbitrary shift is a preview of one of the tools in the government health care rationing toolbox. The government is not just saying outright that they won’t cover the cost of this, they are hiding their financial decisions behind language like “clinically meaningful” to lead people to believe the drug doesn’t work. The Avantis case is setting the precedent for the government to arbitrarily deny coverage to millions of American’s based on cost alone.
This battle will be repeated time and time again over the next few years. Life extending drugs for the sick and elderly will be made harder to obtain in order to limit the costs of health care. Treatments to extend life will be denied over and over — if we let them.
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80 Comments
Welcome to the Obama death camp!!! With the U.K. doing away with a socialized medical program, that doesn't work, you have to wonder what this country is trying to do! It is certain that they will NOT be satisfied until we are all proletarian, and they (the elite) will be the only ones that are allowed first class health care!!
I don't always go to the doctor my friend,……
but when I do,……….
I go to my doctor,……….
stay healthy my friend
Of course, the politically connected will not be denied any life saving medications.
A pox on all of you who voted for this creep because you thought you were getting "free" health care.
Let the government enforced euthanasia begin.
According to a London Paper, oblahma took 6 doctors and 494 members of his staff, to the G20 summit. I guess he thinks he's somebody.
He arrived with
500 staff
200 secret service agents
6 doctors
His own personal chef and kitchen staff with his own food and water.
According to the Evening Standard
He had 35 vehicles, 4 speech writers, and 12 teleprompters.
The press reported on Air Force One and his helicopter.
Marine One and a fleet of identical coys to ferry him to Central London
Plus a long list of other things
And we wonder why our Country is in debt and in desperate need of good health care to survive this criminal.
God Help Us!
FREE PEOPLE OF AMERICA!!!!!!!!!!!!
WAKE UP!!!!!!!!!!!!!!!
THIS IS SERIOUS!!!!!!!!!!!!!!!
This is the beginning of the end people.
We must fight!
Aspirin the new, old cure all.
Take two and call me in six months.
Interesting. I wonder if there is some connection with a rival drug company being in the pocket of lawmakers? Relatively speaking, Avastin is cheap. A similar thing happened in regards to the care and treatment of the wet form of macular degeneration. There was a patented drug, Lucentis, that was being marketed and used for treatment. Then it became apparent that Avastin was just as effective at treating this form of macular degeneration for a fraction of the cost, and many began using it. So it wasn't long before a move was underway to make the use of Avastin for treatment of this devastating disease essentially malpractice.
Four legs good, two legs bad.
"Clinically significant", aahhhh………. so now we as the consumer must beat our way through the weeds,
investing our valuable time to learn these terminology tweaks that will result in almost every drug currently
on the market's efficacy being questioned and redefined.
It would be so much simpler if we just put the NAACP in charge to decide, whom is eligible for treatment.
White conservatives need not apply. We all better get busy clawing our way to the top, clawing our way into
the RULING CLASS, where we'll be safe from these new practices. I predict the USA will become quite top
heavy as a result. Will we become Lady's and Dukes as in merry ol England or will the RULING CLASS
find another way, perhaps a chip implanted to signify our worthiness to receive thorough care.
The oRegime had better hurry to find a way to gain control over the drug manufacturers. Perhaps a take-
over is in order. I look for this labeling information to soon be unavailable to the consumer, after all we
can't expect treatment from drugs we are unable to research.
My, my being a doctor or nurse is about to become a grim, grim profession, as they are instructed to with-
hold treatment to folks who would have been helped formerly. We'll see how they respond when the patient
is from their own family…………or perhaps doctors and nurses will be bumped up into the RULING CLASS.
remember,
sarcasm is my middle name, sort of………..
Sarah Palin's mistake was that she anticipated that Obamacare would have "death panels". WIth the recess appointment of Donald Berwick, it looks like she was wrong and Obama is appointing a "death czar", instead.
This is what that fool Pelosi meant when she said " We will not know what is in this bill until it's passed".
The payoff should be that all members of the US Government should have this type of care DICTATED as their "health care". But then someone might mistake Pelosi or Dodd for a candidate to have the life support pulled on them.
Imagine if one of their family had their choices for treatment rationed to them?
Hypocrites, racists and liars, oh my.
Tell grandma and grandpa goodbye
Barry is a compassionate kind of guy
Soon they will be legally slain
By health care rationing that is insane
Too bad it isn't a plan that Congressional families must buy!
One desperately needed treatment for Obamacare: REPEAL IT!
Repeal & replace! It starts on 11/2!
Sick people are going to feel a WHOLE LOT sicker when they find out that ObamaCare requires physicians to "Tweet" their patients, rather than have a personal office visit. SHOCKING story at:
http://spnheadlines.blogspot.com/2010/03/obama-he...
Peace!
What most don't realise is that this is a REAL life or death struggle….
If we are going to demonstrate that We The People mean business, then it is time to start using all of the options available to us. For one thing, 18 states have provisions for senatorial recall, yet it has never been used. We need to approach 50-state capability and start using it. Put new representatives into office who are assigned the task of repealling all of the Bamatrash for starters. When they fail or refuse to do so, fire them ASAP and replace them with someone who will DO THEIR JOB. If we are serious about curbing corruption in D.C. as well as the runaway ruling class, this must be used. Otherwise, we are just kidding ourselves.
I still can't get over how the Demon-rats wanted to ruin the best healthcare in the world..I
hope the dimwits that voted for him realize what's going on, and if not, wake up you
dummies!!!
It's a shame Obumble and the idiots in DC won't have to worry about their healthcare,,,If
they had to sign on to Obamacare it would have never passed!!
We keep hearing how intelligent the Bambam supposedly is, from all of those tingly leg morons in the lame stream media. The notion that he thinks Brit or Canada style health care is a good thing surely indicates that either the intelligence notion is a farce or else he has something else up his sleeve. Apparently he is too dumb to realize that we have two important Novembers headed our way very soon.
There are so many other ways that the government loses money on healthcare, yet makes no attempts to recoup them.
I work in a busy emergency room. There are so many young, healthy, not-willing to work people (yes, I have examined them) who have no doctor, take no medications, yet are on Medicaid a/o disability for some crap reason (i.e., can't read). Depression is a big one, but no meds or doctor..go figure.
Common scenario – Person comes to the ER has medicaid gold card. Complains of pain that is obviously not real. Gets doctor who does not realize he is a drug-seeker, or does not want the fight. Gives him script for 20 Vicodin. He gets it filled and sells them, making a quick profit for he has not had to pay for either the care or the Vicodin. The taxpayer has.
Once on the roles it is almost impossible to get them off. I have tried. If the American public knew how much waste there is with fraudulent benefits.
You might think that NOW and some of the women's groups might fight back against the gov't rationing of mammograms and breast cancer drugs. But who knows, maybe they are content knowing that you can still
have an abortion as you lay dying of breast cancer
So now the government decides how much longer they think your life is worth prolonging.
If that isn't a Death Panel, nothing is.
Obama LIED, and Sarah Palin was right. There will be DEATH PANELS, set up by the Government to help terminate you when you become too expensive, OR they view your life as not having any worthiness to be granted health care. The Muslim in the White House must be leaping for joy that he will be able to withhold health care from Americans. Obama is a Muslim and that is why he pushed so hard for this, plus it gives him more power.
Being from Canada, I can only give my opinion that our health care IS a good thing.
Yes it is, Deusex,
And Jan 1, 2011 is the BEGINNING of a 15 year TSUNAMI of OLD GUY BOOMERS to hit the health care system.
Millions and millions of aging Americans, VOTERS, WORKERS, THINKERS, PEOPLE WHO BUILT THIS NATION, FOUGHT ITS WARS, EMPLOYED IT'S CITIZENS, CREATED ITS BUSINESSES, AND FED ITS COFFERS AND LINED ITS POCKETS WITH WEALTH UNIMAGINED OR EQUALED.
Citizens slated for DEATH PANEL REVIEW OF WHAT THEIR AGING LIVES ARE "WORTH!"
You want a class war on a platter? I got ur class war right there.
IF GOV'T THINKS BOOMERS ARE GONNA LAY DOWN AND CONVENIENTLY DIE TO HELP SOLVE PESKY BUDGET PROBLEMS…..THEY GOT ANOTHER THINK COMIN.
Rebas,
Unfortunately, congress at the state and fed level has spent YEARS passing laws to gut that recall power. Some states have even outlawed it.
The problem with people in power is once they get there, the first thing they do is INSURE ways to stay there. Recall, if it's even legal, takes literally YEARS. You can vote folks out before the first court ever even gets to see a recall petition. And it costs a FORTUNE. And it REQUIRES OTHER FOLKS SUBJECT TO RECALL TO VOTE TO RECALL ONE OF THEIR PEERS.
They have made it a true paper tiger….just like they insured THEY AND ONLY THEY GET TO DETERMINE THEIR SALARIES. NOT TAXPAYERS.
They may be crooks…..but they ain't stoooped crooks. They know how to secure their own position. Probably more experts in THAT SET OF RULES than any other aspect of their job!
yeh, QA….
SEEEEEE……Palin was WRONG. They ain't death panels. Why pay a bunch of folks when one CZAR can do the job, one UNELECTED, UNVETTED, UNAPPROVED CZAR.
When did we get CZARS? Did I miss the meeting? Fail to get the memo? Where in the Constitution is the CZAR clause? And while we're at it…..where in the name of REASON does it say a sitting US PRESIDENT can, let alone should, ensconce a FOREIGN NATIONAL in the WH and allow him, Soros, to participate in high level policy making?
That's just nutz.
Rebas and Stan,
Might just be easier and faster to DEFUND THE WHOLE PLAN.
"Great idea and as soon as we find the GAZILLION DOLLARS A YEAR it will cost, we'll get back to you on implementing it. But for now, we just don't got no money to inact it. So stick that sucker in a drawer for when we're, uh, SOLVENT.
Then we'll take a look at it……maybe…..if it ain't rainin…..somewhere.
)))
Beaver,
The gov't can REQUIRE anything they like. But they cannot FORCE doctors to TWEET diddly. Especially with teams of ambulance chasers ready to sue them if they open their mouth, let alone TREAT someone.
Doctors will do what they've always done the way it's supposed to be done, or they will quit and do somethin else. The crisis may not be monetary. It may well be that nobody sees much future in bein a doctor. Many even before this law is enacted have retired, or are planning to retire. Others refuse to see MC/Mcaide patients. Cash only.
And that, my friend is a whole other kind of ugly.
This president is an idiot, a narcissist, and he will bring down this gov't and take every dem with him if he keeps on opening his mouth. Lame duck is proactive compared to Obama's clout with the public. Aside from Gibbs and his kids, NOBODY TAKES HIM SERIOUSLY. NOBODY. NOT EVEN HIS OWN PARTY. HE IS NOW A LIABILITY TO BE MANAGED BY EVERYONE IN POWER. HE AND HOLDER. THE BONNIE AND CLYDE OF AMERICAN POLITICS!.
Your call as to which one's Bonnie…..bwahahaha
Except for the fact that they are the ones who get to vote themselves into this lousy "reform" and that aint going to happen.
Their goal is to destroy the opposition….literally!
With all these old people being nudged into an early grave, whatever will all those plastic surgeons do? A P.S. without wrinkles to remove and saggy skin to tighten just might starve.
This is not surprising. The UK has been doing this for years.
Time to back up a step, then, for state constitutional referendums to streamline the process. Some how, some way, the people have to decide if power ultimately rests with them or if it rests with the self-defined ruling class parasites. If power belongs to the citizenry then we have an awful lot of cleanup work to do.
Some people will be able to get whatever they want, you just need to know which official to bribe. And people figure that out pretty fast.
This is how communism works. Just be sure you stay on their good side.
Sigh. You've pretty much got everything wrong here.
Avastin's indication to treat breast cancer was originally fast-tracked a few years ago based on some preliminary data. What that meant was it had shown benefit in other cancers (lung, renal, colorectal) and there was some data that showed that it could be beneficial for breast. So, without a full submission to the FDA, it was approved pending further studies.
Last week, data from the RIBBON trial were released and it showed that Avastin didn't really help women with metastatic breast cancer compared with currently available therapy. When you added the cost of the drug (which is really, really expensive, by the way) and its toxicities (which there are many), the advisory board (not the FDA) recommended that the preliminary indication for breast cancer be removed.
Why? Was it because of Obamacare? Was it because we want to limit treatment for sick people? No, it was because the panel — which is not the FDA, but a group of physicians and scientists who study this stuff, convened to give their opinion to the FDA to help in making a decision — saw that the drug showed no significant increased survival over what is currently prescribed.
To me, it looks like this FDA advisory group is protecting the population from paying for a drug that doesn't work, that is expensive, and toxic.
Avastin will still be available and will still be used to treat many patients with many different types of cancer and it will continue to help people extend their lives (albeit only for a few months).
Tell us, then, why so many Cans come across the border for expedient cutting-edge medical technology. Tell us why it is a good thing for the gubmint to have it's nose placed squarely between the patient and the doctor, and while they are at it, completely interfere with the basic human right of free people to form contracts between themselves. Tell us why the lazy bottom dwellers should be made so comfortable in their non-productiveness while hard working producers should have their earnings redistributed by an overbearing government to pay for the health care of the bottom dwellers. Tell us why all of a sudden health care is a basic human right that automatically demands wealth redistribution to cover its expense? Funny how Our Founding Fathers didn't recognize or enumerate it in the Bill of Rights.
Money has no place in patient care. Neither does age. All of our resources should go for extending life for all. communists don't believe in this. We will watch and we will vote!
Obama, Pelosi, Reid, Axelrod, Holder, et al. You came so close to Re-distributing wealth in order to convert America into Communism. Didn't anyone tell you it's Impossible in America! We learned from you. We're involved. Never Again!
Rebas,
Oh yeh. There are two ideas "out there" that we the people COULD DO that would, just by themselves, take much of the power and ALL of the group think, group spend, pack mentality out of the House. Since all spending must originate in the House one measure would in one fell swoop dismantle this pack of spend drunk jackals and ISOLATE them from K Street and each other. After all, their main job is to sit around "imagining" problems we don't have and then "creating solutions" we can't afford to fix them.
Google the info on E-Congress.
House members would not go to DC. They would not immediately REMOVE THEMSELVES from the folks they REPRESENT. They would not have private jets, and buckets of staffers, and $1500 dinner meetings, and endless, grovelling minions to get from one room to another. They would STAY HOME, USE THEIR COMPUTERS AND PHONES TO GET TOGETHER. They would meet a couple of times a year to vote on big bills and joint session votes, but it's hard to twist soneone's arm when they're 800 miles away in another district!
Also regular citizens could step up. They wouldn't have to mount million dollar campaigns or relocate their whole family just to serve. And with all the cool perks and hoity toity power trip taken away, they might not WANT to make it a 40 year career. And if they work hard at it, they could even keep their businesses, or take a leave of absence to serve.
I know….HUGE CHANGE. HARD TO GET FOLKS TO THINK OUT OF THE BOX. The Founders could not have imagined this age of instant communication by any number of ways. It took some of them weeks just to get to DC. I think if they were alive today, they might even consider it for the House. They were not just smart, they were THRIFTY and would immediately see how much this would save taxpayers and how it would put a "check" on egos fluffed all day every day in DC.
What I DO KNOW is if we keep sending good people to that same corrupt place to be bullied by the same corrupt parties into doing the same corrupt job the same corrupt way under the same corrupt rules of order……NOTHING WILL CHANGE.
Anyone who thinks about this system will soon realize this is the fastest way to CONTROL the House and make it truly a representative body responsive AND accountable to constituents.
Thanks for the clarification.
:www.datamonitor.com/store/News/avastin_faces_breast_cancer_setback_but_will_likely_retain_leading_position_in_oncology%3Fproductid%3D4A11D92F-3FB1-4261-A091-E6FDC92DFEF9+datamonitor.com+Avastin&cd=1&hl=en&ct=clnk&gl=us” target=”_blank”>http://webcache.googleusercontent.com/search?q=ca...” target=”_blank”>:www.datamonitor.com/store/News/avastin_faces_breast_cancer_setback_but_will_likely_retain_leading_position_in_oncology%3Fproductid%3D4A11D92F-3FB1-4261-A091-E6FDC92DFEF9+datamonitor.com+Avastin&cd=1&hl=en&ct=clnk&gl=us
"Avastin faces breast cancer setback but will likely retain leading position in oncology"
Tell us why rapidly improving technology out of medical research seems to be primarily sourced from the U.S. while Brit and Canadian medical breakthroughs are few and far between? Could it be that the lack of freedom in the socialist medicine 'markets' quells investment, leading to stagnation of the growth of life-saving technologies? Tell us who in the world is going to take over being the leader in developing medical technology once the U.S. goes into incentive-killed socialist gubmint-controls-everything-under-the-guise-of-cost-control idiocy , which the slow-to-admit-mistakes Brits finally, after 60 yrs of nationalized healthcare, admit was a horrible mistake.
Another Christmas with the family. The birth of a grandchild. The marriage of a son or daughter. It is only in those times where one can truly feel your own life's limitations that these moments take on a meaning beyond that which the unafflicted could ever imagine. 5 or 6 months can be the most precious time for the individual and their family and I sincerely condemn anyone who would attempt to take that away. If that turns out to be our own government, then I will at least know the face of my enemy.
Honor and integrity are long out the window when an organization such as the FDA allows itself to be manipulated into playing the semantics game on medication labeling for political purposes. There was a time in history when the FDA seemed to do a fairly honest job of looking out for the Public's best interests. Now that it is a political tool, one has to ask who is watching the FDA, or can do anything about it's ill-conceived evils?
Were are the liberals who called Palin a fool for saying death camps. Where????
Yep, I've been all for E-Congress ever since I first heard about it. If we can't remove them from office so easily, then at least they ought to spend most of their time in their districts and have to listen to and see quick feedback. Also makes life that much less cushy for the special-interest lobbies.
I'd like to add to that line-item veto power and single-issue bills. Riders dissappear, becoming their own bills if the sponsors think that they have enough merit to stand on their own, rather then getting laughed out of the House and Senate as much of the schlock we have seen go through the legislature in the past two years well deserved.
Shhhhhhh- don't give them any ideas about complicating out pets' health care. If the jackazzes in D.C. see a dollar in it for them, we'll be doomed there as well.
Actually, clinically significant is what is used to determine the efficacy of every single drug out on the market. In layman's terms, it means that you treat a group of patients with standard of care or placebo or some sort of drug that is currently approved and you treat another group of patients with your experimental drug.
If group a (the current standard of care) extends life 15 months and group b (the new drug) extends it by 15.5 months, the likelihood is that that data are not clinically significant. Significance is usually measured as a P value, and any P value that is lower than .05 means that the data is good. That says that if you run this same experiment 100 times, the same result will be repeated 95 of them. The lower the P value, the greater the likelihood of something being beneficial for a lot of people.
You, the consumer, will not have to really figure this out. This is the job for your doctor, for people in the scientific community, for people at drug companies, for people in the FDA. You should know that when a drug comes to the market, it has to reach certain levels of safety and efficacy.
Unfortunately, it doesn't always protect us from everything (as we've seen recently with some drugs), but it should make people feel pretty safe.
ABSOLUTELY. COULDN'T AGREE MORE.
I know how hard it is to "HAVE A VISION SO TOTALLY DIFFERENT FROM TRADITION" and how hard it is to convince folks to try to see what a totally new landscape might look like, how much better it could be….especially now when folks really don't trust anyone or anything but themselves.
Change…sweeping, scary, BIG change is always soooo hard. Until it's proven to work. Your ideas of line item veto and single issue bills ARE GREAT….but until congress, the only folks affected by these laws, and the only folks who can pass them….do so….we won't get them.
Right now, while they still NEED US, NEED OUR VOTES….I urge folks to get out pledges, get candidates to SIGN THEM….AGREE TO THESE CHANGES…AGREE TO PASS THESE LAWS. E-CONGRESS….it will take longer. But your add ons can be done by one session.
Guess we take what we can get and hope that down the road folks realize until we make a big change we won't get a big change.
Fingers crossed. I'm calling both MY candidates for Senate and congress and emailing them that pledge to work for line item veto and single issue bills. At least that way if they violate the pledge….I won't HESITATE TO TAKE OUT AN AD IN THE PAPER SHOWING THEIR SIGNATURE ON THAT PLEDGE.
After Nov. we won't have much leverage. We need to get these folks ON THE RECORD NOW. Even if they decline….that's an election ISSUE too.
Extending life may give needed time for new treatments that cure. Oh…but thats not really health care.
Evidently MY point just flew right over your extremely educated noggin, no matter what the defini-
tion or common terminology within the medical field, consumers of oCare will be uncomfortable
with the treatment their doctor prescribes as the Fed Gov't exercises it's muscle in all matters
related to the health of the American consumer.
"You, as the consumer, will not have to really figure this out."………..surely ye jest? Over and over
we the public hear of mis-diagnosis, over medication, etc, to the point we eventually don't know a
single soul who doesn't have an anecdote in this vein. We absolutely DO NOT feel safe, and will
feel LESS SAFE as oCare seeps into every nook and cranny of the US healthcare system.
Doctors and health-care workers are in for a shock when the American consumer begins the ques-
tion and fight back. The doctor/patient relationship has been forever altered. It won't be long until
Doctors are reviled, as Lawyers are already, including being the target of much very dark humor.
.
But this has nothing to do with Obamacare or healthcare reform in any way. You're being overly paranoid. This is about a group of people — none of whom are part of the FDA, by the way — who looked at data and made their opinions known. The members of this committee were not political appointees and they have no left- or right-leaning agendas. They were trying to to see if this drug was effective and safe in fighting metastatic breast cancer.
This drug is likely not going to be approved for this one type of cancer because it doesn't work in this one type of cancer. Get it? It has nothing to do with Obama. It has nothing to do with a doctor/patient relationship.
Get over yourself.
She was wrong about death panels. She assumed a degree of honesty and humanity that the Leftoids simply do not possess.
There are no data showing that this drug extends survival in patients with metastatic breast cancer, people. This is yet another argument where there is nothing to complain about, but you continue to do so.
This is why people on the left laugh at you. You're arguing a point with nothing to back you up, yet you think that if you repeat the talking points that Obama/Pelosi/Reid are trying to kill us all, you think you'll win by scare tactics.
So in a way, Sarah was indeed wrong. A death "panel" suggests there will be discussion, debate, etc. As we can see, there will be little discussion. It's a done deal.
Here is your "laff 'o the day" folks. I wanted to see what the other, brainless side thought of this decision. I went to Democratic Underground and searched for "Avastin". Lo and behold, the threads were there! But they were mostly from '08 and were about evil insurance companies refusing to pay for Avistin, and threads about the FDA approval of Avistin. About this latest move? Not a friggin' peep.
"paranoid"??????…………….Ooouuuuuueeee…….. Thanks for the diagnosis skippy darlin,
What do I owe ya? …………Alinsky much? I threw out the bait and you swallowed the hook clear
down to your rectum. That hook's gonna hurt commin out, eeewww skippy, I feel yo pain, not!
"Get over yourself"……….mercy skippy………..a two pronged attack??? Crawl back in your bunk,
have a siesta on me. After all, what do they expect from you at minimum wage? I understand
running interference for the oRegime can be a thankless job.
'Kaaaaaaay now get back to brow beating anyone else on the thread that might be the tiniest bit
critical of your masters. Medical definitions and terminology are always important to be precise
and perfect (not), of course the overall point is completely lost on your egghead. You may now
reinsert your head in your ass.
BTW, seems you didn't bother to read the article, perhaps in the future that would be helpful.
FoP
.
To all those who shrugged when the EPA used junk science to justify the banning of second hand tobacco smoke…"actions have consequences." Let them get away with it once….
I'm a cancer researcher, so please believe me when I say that this is not rationing. Recission of approval on drugs happens all the time, and here's why:
When people with a terminal disease (like metastatic cancer) are likely going to die given current treatments, drugs hoping to help those people are "fast-tracked" by the FDA, which means that a full assessment of effectiveness and safety isn't carried out so the FDA can get the drug to the patients as quickly as possible. These fast-tracked approvals always require that researchers go back and determine if the drug does, in fact, help and not do more harm than good. In this case (as with many drugs over the years), research showed that Avastin does more harm than good for these patients, so it shouldn't be given.
Decisions like these aren't new, it's been part of the drug approval process for years. There's nothing overtly political about it (well you could argue that the FDA approval process has been "influenced" in the past, but that's another debate, and I don't see anything about this case that looks like that).
I'm just speaking from personal experience. I don't know where you get your numbers about so many Canadians crossing the border but the vast majority stay in Canada to get their health care for free. The ones who cross the border are the ones who don't want to wait for non-emergency treatment. The government isn't squarely between the patient and the doctor. I go to any doctor I want and the bill goes to the government.
We don't feel so much that our hard earned tax dollars are going to lazy bottom dwellers, so much as being held for ourselves in case we need it. When my 89 year old mother fell down last year and broke her hip, there was no thought at all to how the family would pay for treatment. The question never comes up.
Taking Avastin off label for breast cancer doesn't make much sense economically. It is not very expensive. I have a relative who was treated with Avastin off label for macular edema due to blocked blood vessels and the charge was only $55 per shot for the drug. If the drug is used off label insurance will not pay for the drug even though it pays the doctor to inject it.
There is another drug used for the same purpose that costs ten times that amount and whose effectiveness is, at best, only slightly better.
You may be right about rival drug companies being involved. In England Avastin was not permitted even for macular degeneration unless (I am not making this up) you are already blind in one eye!!!
I did read the article.
Take this part:
"Standard practice for evaluating drugs is to use data-driven objective endpoints to evaluate effectiveness and safety. In the case of Avastin, the FDA has arbitrarily and unilaterally stopped using this objective criterion and are applying a highly subjective criterion of “clinically meaningful”—to cut costs."
False. The evaluation by the advisory panel is based data from two trials: AVADO and RIBBON. Both trials showed no extended overall survival. That's why they're considering taking away the breast indication.
More: "No one disputes that the drug helps extends life for terminal patients."
For some cancers it does, but not for breast cancer.
And more: "While six months might not be significant to a statistician or a bureaucrat, for the families of a loved one or a dying patient, it’s a lifetime."
Avastin doesn't extend survival in patients with breast cancer at all, so it certainly doesn't do it for 6 months.
Should I continue?
If the drug is expensive, ineffective and toxic then any doctor recommending it should immediately stop. If the research is good then any competent clinician can make that call, assuming that he bothers to keep up with the literature in his field.
When used to treat macular degeneration the drug is certainly not "really, really expensive" yet its use in England was stopped (unless you have already lost the use of one eye) supposedly because it was too costly. The typical cost of an injection of Avastin into the eye is about $55. That's not a guess, or from a news story, that's what I actually paid for its use off label for a relative.
A year's worth of Avastin can cost as much as $100,000 for cancer, where the dosage is significantly larger than in macular degeneration.
In doing just a minuscule amount of research, I found that the typical Avastin dose for macular degeneration is 1.5 mg every 4 weeks. For breast cancer, it's 10 mg per kg every other week. So for a 130 pound woman, that's 680 mg every 2 weeks.
1.5… 680… Do you see why one is more expensive than the other?
The problem is that Obama, Pelosi and Reid are trying to kill us all even if the Avastin case is legitimate (which for the most part it appears to be). If death were not their goal they would not have put Berwick in charge.
Berwick is a strong advocate of rationing. He has stated clearly and unconditionally that good health care means government rationing and removing profit from medicine. Every country that has done that has sentenced many to die for lack of medical care.
Furthermore, if life were their goal they would denounce Ezekial Emanuel's article in the Lancet where he calls for depriving the elderly of care so that more care would be available for the younger, more productive citizens. Of course Emanuel said that this was only intended for "emergencies" where resources were limited. That argument fails for two obvious reasons.
One, everything that the government does is justified as an "emergency". The state of Washington financed two athletic stadiums that had been rejected by voters because it was an "emergency". What "emergency" meant was that construction union votes were necessary for the governor to remain in power.
Two, all resources are limited. Medical care is limited but then air is limited, the oceans are limited, heck the entire universe is limited. What they mean by limited is that medical care doesn't go exclusively to the ruling class and those who keep them in power. Holding the power of life and death over the average man tends to make him more compliant, more obedient and more miserable.
The point should be clear. Disease outcomes in the United States are the most favorable for any country in the world. When murder and accidental deaths are removed from the total (since they do not reflect on medical care) the US has the longest life expectancy. Changing this system to one of state medicine will reduce life expectancy and therefore kill innocent people.
Control of medical care is just one part of the progressive movement's attempt to remake America.
Sure skippy continue to your hearts content……………whatever makes ya happy…………
Perhaps you should be arguing with the author of this piece, who might give a damn what
you think, ………….
Me?………..personally you have begun to bore me terribly with your rather narrow and
somewhat clinical grasp of this issue………….
.be gone, NOW, freakish little egghead. I'm done playing with you.
.
Emaunel did not call for depriving the elderly of care. What he said was when there are medical procedures that are already limited — like in organ transplants — we should give them first to younger patients instead of the elderly. Those such instances are commonplace already. It's why any patient — if they get to be too sick — is taken off transplant lists. It just happens that more elderly people get to that point than younger people.
But drugs like Avastin are readily available and there has never been rationing. You can't compare a marketed drug and a kidney.
And that meme of the US having the longest life expectancy except for accident and murder has proven to be false. There are not that many accidents and murders in the US that would push it past 28 (or so) other countries.
welcome gwo, I'm curious…………
What prompted you to speak out on this matter for your first foray into our BG discussions?
I hope you realize that this knee-jerk reaction will play out over and over in the coming years as we con-
template our fate under oCare. The medical community/pharma made their choice to go along with the oRegime's seizure of health-care against the will of the majority of Americans, and as a result have lost
their credibility with us. The details of each tiny instance loses importance within the larger context.
I'm sure millions will be spent on PR campaigns in efforts at damage control, money that could have
been spent on research. Sadly the oRegimes appointment of folks like Berwick only magnify this mis-
understanding. Perhaps some really good PR folks will be able to convince us we should be satisfied
with living a slightly shorter life. We'll see.
.
I actually read Emanuel's paper and he did call for depriving the elderly of care in no uncertain terms. Look at his chart where health care (not kidneys, health care) is shown tapering off after the age of 50 and dropping precipitously after the age of 60. His argument was in terms of "quality life years", not kidney transplants available per person.
And the death rate from accidents and murders in the US is higher than every country in Europe. The US murder rate is about 7 per 100,000. No advanced country comes close. Worst still, is that accidents and murder affect young people much more than the elderly so you're adding a lot of teens and twenties into the death statistics.
Americans drive far more than most other countries so even though the deaths per mile is better than in Europe the vastly greater number of miles driven pushes the overall death rate higher.
Disease outcomes are better and life expectancy in the US is longer.
Proven to be false? Show me the proof!
But the care he's talking about is specifically for scare medical interventions. That's what the article is about. In fact, the first sentence of the abstract is:
"Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge."
That's what he's talking about. He's not talking about knee replacements or bypass surgeries. So you must not have read his paper.
As far as life expectancy, I did a 30-second google search and found this:
http://papers.ssrn.com/sol3/papers.cfm?abstract_i...
Yes, that's reasonable.
But it doesn't explain why the British system demands you go blind in one eye before you get that 1.5 mg. Berwick is a great admirer of the British system.
And all I can say is that Obama's healthcare system is nothing like the British one and what NICE does has no relevance on what is happening in the US.
And it's not that you have to go blind before you get the medicine; the government just won't pay for it. We have that here, too. If a drug is not indicated for a specific disease, insurance companies very often will not pay for it. Which is why Avastin is costing you $55 per injection instead of a $20 co-pay.
The ObamaCare system is like RomneyCare far too expensive and inefficient.
It's a system designed to break the back of taxpayers as it is doing in Massachusetts. When that happens the serious rationing begins. Drive the price of medicine through the roof with initially unlimited funding, declare that the system is "out of control" and then begin the cost saving or executions depending upon your viewpoint.
I commented now mainly because this is one of those few times where I know a lot about the issue and wanted to share what I know about what's going on. The research really does show little effectiveness at treating the cancer and causing serious liver damage. The assessment was made by a panel of practicing physicians at schools and hospitals from all over the country. They don't work for the FDA and they aren't paid.
I'm all for calling out the government for wrongdoing, but there isn't any here. I think that wrongfully accusing the biomedical community with doing something sinister is not helpful.
There's a difference between "scarce" and "limited"?
Scarcity is a relative concept and it doesn't apply only to individual treatments but to entire medical facilities and the number of specialists. I read beyond the first sentence where Emanuel begins the "quality life years" arguments. There is no way to distinguish between "scarce" treatments and "plentiful" ones because the major cost is not the treatment but the doctors and the facilities.
His arguments apply to all treatments because medical costs are fungible. Denying the elderly care doesn't mean that the artificial knee joint goes to a 20 year old, it means that several single moms can bring their children to the doctor for every little sniffle and several moms can outvote one elderly cripple.
The paper you cite (which I read) is typical of the argumentation against "Ohsfeldt and Schneider" in that it states that O and S failed to account for several variables but then the author does not proceed to account for them himself. He uses terms like "implies" or "suggests" but never produces actual calculations. Sorry, but qualitative reasoning is meaningless without statistical analyses to back it up.
The Wall Street Journal "Numbers Guy" did the same thing. Challenging statistics with qualitative arguments has become something of a cottage industry. It's why leftists get laughed at.
Lessee…"Clinically significant" appears to mean "politically expedient". Just this week, there were serious news stories reporting that the British NHS was developing a strategy to deny "elective surgeries" like knee and other joint replacements and end of life care, which is simply code for trying to find a way to pull it off without rioting in the streets. It will happen here. I'm as certain of this outcome as I am that the sun will come up tomorrow morning. It's inevitable and unavoidable. It simply HAS to happen, all the lies from our sleazy politicians notwithstanding. Once the federal government starts spending money a couple of years from now, and the costs of the program and the horrendous costs of administering it become apparent, it will become obvious that cost cutting absolutely must happen SOMEWHERE. Cutting administrative costs will simply never be discussed. The money willl be taken from patient care. De-labelling expensive drugs is just the beginning. It's going to get a lot worse. Your life will be in the hands of GS-9 government beancounters who don't give a crap about how the end of your life turns out.
It's absolutely obvious to anyone paying attention that the group that will suffer the most are the Used Up Americans – our aging baby boomers, me included. The arguments will be very carefully worded, but the underlying truth of it comes from Eugenics. Old people are worth less than young people, and anybody who denies this is either a complete idiot or they're lying.
There's no way to avoid saying this: It's gonna suck to get old in America.
I imagine most here know and understand how the FDA approval and review process works.
Few who comment here are ignorant, and I find it quite amusing when folks such as yourself
come on to comment, interestingly it is most often to defend the current process. I will not de-
fend the author, however as often these folks research is somewhat thin.
As to the liver damage issue, perhaps those dying with cancer need not worry about liver damage.
Why not just pronounce the drug ineffective and leave it at that? The liver damage issue seems
unnecessary, to those of us with an once of common sense.
If the biomedical community had stood with the majority of citizens of the USA in our rejection of this abomination we are calling Obama Care they would have a leg to stand on. However in their fear,
arrogance, and perhaps a little greed they chose to stand against US. The result will be our undy-
ing mistrust and suspicion of any and everything that comes from their mouths, for years to come.
Hence, sadly more of this type of rejection and revulsion. We have sufficient anger to spread be-
yond the usual hatred of our Fed Gov't, yes we remember those who in their own interest joined our
adversary. What this Regime has caused by dividing us into tribes will be generations healing.
Good Luck to You and your colleagues.
The people of America still make the false assumption that the FDA is in place to protect them, that assumption has killed millions of unsuspecting people. How may drugs have been recalled, how many people have been killed, crippled or otherwise irreparably harmed by drugs that have been approved by the FDA? Wake up people the FDA is just another branch of the government designed to siphon funds from the economy they serve no other purpose. But I guess now they will have a dual purpose so we will be getting more for our money so to speak, the FDA will be used to help ration health care.
Why do you continue to change the parameters of the argument every time you're proven wrong? You say it's not expensive and I show that you're wrong. You then start talking about the British health system (for whatever reason) and I show you how your argument is wrong there. And now you start talking about RomneyCare in Massachusetts even though that has nothing to do with any of this.
I guess this is the Breitbart way, though. You're wrong and you deflect, deflect, deflect.
Maj. Gen.Jerry R Curry (Ret.) Speaks Out On The Obama Eligibility Issue
http://www.youtube.com/watch?v=fO8n4Pij158
Donald Berwick, king of the death panel. Do the math.
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