It begins: FDA may pull Avastin approval over cost concerns
posted at 12:15 pm on August 16, 2010 by Ed Morrissey
When Barack Obama and the Democrats spent most of a year pushing their deeply unpopular health-care system overhaul, they repeatedly insisted that government intervention in the market would not mean that treatment decisions would come down to cost issues — even while demonizing providers as Tonsil Vultures and amputation-happy predators. Today, however, the Washington Post reports on an effort at the FDA to decertify Avastin as a treatment for breast cancer and its implications for cost savings at Medicare:
Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.
The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments? …
The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment.
“It’s hard to talk about Avastin without talking about costs,” said Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs.”
Avastin got approved through a fast-track process demanded by Congress several years ago when complaints about the length of getting new treatments approved reached a fever pitch. Subsequent testing has called into question some of the assumptions made about Avastin, particularly about the effectiveness in delaying advanced tumor generation in breast cancer. However, others note that the drug works for a large number of women, even if it doesn’t necessarily work for them all:
“I’m very upset,” said Leslie Twohig, 48, of Lothian, Md., who has been taking Avastin for eight months and credits the drug with helping her survive. “How long will I be able to stay on Avastin? Are they going to take it away? I know it’s working for me. Right now I am able to enjoy my life. Every morning I wake up and wonder how long it’s going to go on.”
“I am very concerned about people who are receiving the drug and may feel threatened that they may not be able to receive it,” said the Dana-Farber Cancer Institute’s Winer, who is also chief scientific officer for Susan G. Komen for the Cure, a breast cancer patient advocacy group. “This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit. “
Would the FDA even be re-reviewing Avastin for its application to breast cancer without the cost issue? I’m skeptical. As the Post notes, the FDA doesn’t do a lot of follow-up on fast-tracked approvals. Avastin didn’t just get lucky to get renewed attention from the FDA.
With the new ObamaCare regime in place, the issue of cost has now become openly part of the FDA process. This is a perversion of their mission, which is supposed to only involve product safety and effectiveness, not bean-counting. If Medicare doesn’t want to cover Avastin, that should be a separate issue handled by CMS and HHS. This strongly suggests that the FDA has become politicized to a degree where their recommendations lose credibility — a dangerous situation for consumers and providers alike.









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So I am assuming that this was a group decision, that this group or panel (agency) had to decide that a person may die, but the cost savings is worth that decision.
So, for the sake of saving money, this panel is deciding that a group of people can die.
I think some people have already had come up with a name for this panel…
I want to thank the hundreds of women who are going to sacrifice their life, so my Obamacare does not spend too much money.
I would hope that the EPA would have a wall with these names, kind of a “death memorial” honoring those women who will die of cancer, as they waste away in bed, knowing that our rates won’t go up.
I am sure the government will remember the 17,500 women…maybe even create a new color ribbon for them, maybe a plastic bracelet.
My God, what kind of animals have we put in charge?
right2bright on August 16, 2010 at 1:09 PM
Good, because I don’t imagine government insurance will find you all that cheap to keep healthy. Hopefully we can fight ObamaCare so that you don’t have to as an individual.
Esthier on August 16, 2010 at 1:10 PM
From the article:
A question not in the article — but it should be: Why should the FDA be involved in the previous question?
tom on August 16, 2010 at 1:10 PM
Do you think:
1) that the FDA blew it and needs to review this potentially in-effective and possible dangerous drug?
or
2) that the decision to re-review the drug is a political one, based on a liberal ideology that believes it costs too much and therefore won’t be supported?
If you choose #1, then I would expect you to vocalize your dissatisfaction with the inept and dangerous policy of the FDA, and that you expect heads to roll at the top of the agency.
If you choose #2, you’re a shill too.
BobMbx on August 16, 2010 at 1:11 PM
PS> I voted for McCain and think Barry is an insufferable, arrogant jacka**. I would rather cut off my right arm than work for the Democrats in any capacity.
‘
I work off of facts, and the fact is Avastin’s efficacy is extremely suspect. If it cost was $10, I’d say who cares? But at $55K a pop, it we ought to be sure it works. That’s all.
rcpjr on August 16, 2010 at 1:12 PM
The only thing the federal government ever finds too expensive is much needed military hardware.
I am sure there has to be some sort of food stamp program to raid in order to pay for this medication.
tommer74 on August 16, 2010 at 1:13 PM
I was just quoting Russell Kirk in the headlines. His words apply here as well. Emphasis of the blogger who put this together. He did an excellent post summarizing a few salient points from Kirk’s The Conservative Mind. It’s well worth reading.
INC on August 16, 2010 at 1:13 PM
Millions must die for obama’s utopia. Get used to it shrivs
Inanemergencydial on August 16, 2010 at 1:13 PM
Will this be a TV ad this fall? Nope. The GOP is too clueless to realize this is how you convince people that O-Care is a disaster. Instead you have Boehner giving speeches.
angryed on August 16, 2010 at 1:14 PM
$10 says AVASTIN is already a permanent feature in the Congressional Pharmacy.
BobMbx on August 16, 2010 at 1:15 PM
I understand what you are saying but how many people does it have to help to be deemed worthy. There are all kinds of medications on the market that work for some but not for others. So while I see debating coverage, why debate availability?
Cindy Munford on August 16, 2010 at 1:15 PM
Isn’t that your position?
Esthier on August 16, 2010 at 1:16 PM
Will these sufferers of breast cancer be able to at least select the music they hear and the images they view when they “go home” a la Sol Roth in Soylent Green?
cyclown on August 16, 2010 at 1:17 PM
I hope this logic applies to other fields, like electric cars…e.g.; the $60k Volt.
Gee, I hope it works or we’ve wasted billions.
BobMbx on August 16, 2010 at 1:17 PM
I get your point, but I don’t see why that should matter for whether or not people are allowed to take a drug. It’s on the consumer to decide whether or not the money is worth it.
Esthier on August 16, 2010 at 1:18 PM
I blame a ringing phone. Disrupted the literary continuity.
Mea culpa. But you get my drift, I assume.
BobMbx on August 16, 2010 at 1:18 PM
How do you think this will effect investment and research in new drugs?
Chip on August 16, 2010 at 1:19 PM
Does this shock me? Nope!
To play on Graysons own words. Democrats just want women to DIE!!!
capejasmine on August 16, 2010 at 1:21 PM
Wealth spreading, example #1,893. We’re supposed to be like a gigantic convoy crossing the Atlantic in 1943. No faster than the slowest ship.
For us, its “no one is to be healthier than the sickest one”, “no one is to be richer than the poorest one”.
Communism. I hope somebody gets to enjoy it. I know I don’t.
BobMbx on August 16, 2010 at 1:22 PM
From WSJ:
My emphasis.
So those 1 – 3 months aren’t worth it? I’d also like to see those studies to look at their validity.
In the same article Vitter takes up the cause:
INC on August 16, 2010 at 1:23 PM
A lumpectomy with radiation therapy treatments has been shown to be just as effective as a radical mastectomy, much less a double mastectomy.
The radical mastectomy is cheaper, and would probably be the treatment of choice for federal bureaucrats. But for patients, in most cases, it makes a lot more sense to remove the lump and treat with radiation.
My wife used to work for radiation oncologists, and they would get very exercised about women getting unnecessary mastectomies usually because of their doctor’s recommendation, when the less radical treatment was so much better, if more expensive. But then, many of the patients who had the mastectomies would then pay for plastic surgery to try to “reconstruct” the breasts, so they weren’t even saving money in the long run.
tom on August 16, 2010 at 1:24 PM
Hey.
They are willing to stand by and watch women die to realize their political utopia.
I guess killing children would be worse – so they do have some room to fall before they hit rock bottom.
An unbelievable world.
Dorvillian on August 16, 2010 at 1:27 PM
THIS!!!
Cindy Munford on August 16, 2010 at 1:29 PM
You know, it’s kind of sad for the Oppressives/Socialists/Collectivists/Statists/…
They used to get away with fooling people and getting to accept these types of Oppressive Regimes before they learned the truth and it was too late to get rid of them.
Now days, information moves a lot faster and we have the perspective of history to look back on and we can see them for what they are.
Chip on August 16, 2010 at 1:29 PM
This is the NEW and IMPROVED FDA. Barry Style.
bloggless on August 16, 2010 at 1:30 PM
Exactly.
I’ve tried to do my part. I made this w/the Ohio Project in an attempt to get an issue on the ballot for 11/10.
ObamaCare needs to be defeated, post haste. In the courts, in the Constitution, I don’t care. It needs to die. The quicker the better.
Crippled Conservative on August 16, 2010 at 1:34 PM
If people wanna buy it with their money let them. If the goal here is to stop medicare/medicaid recipients from using it, just say that. Don’t take it off the market for people who are willing to pay for it.
lorien1973 on August 16, 2010 at 1:36 PM
Obamacare: Who’d thought that it would be a lousy remake of Logan’s run?
Colbyjack on August 16, 2010 at 1:38 PM
I think this is what we call a decision made by a version of what some of us called DEATH PANELS.
devolvingtowardsidiocracy on August 16, 2010 at 1:39 PM
Hey. Just tell the women it is an experimental drug. Give half of them a 2 cent placebo and watch the costs go down 50%.
seven on August 16, 2010 at 1:41 PM
Democrats’ new campaign slogan
“We hate babies, boobies, and bobbies (English for police)”.
Mo_mac on August 16, 2010 at 1:41 PM
tom on August 16, 2010 at 1:24 PM
When the woman is open, they usually take some lymph nodes from the axilla and get a frozen section. Often they are marked and prepared to do a total mastectomy including a skin rotation graft. You can’t do a bilateral radical mastectomy.
seven on August 16, 2010 at 1:44 PM
Or sometimes a mastectomy is never discussed.
Cindy Munford on August 16, 2010 at 1:49 PM
My mother received leukemia treatment at the age of 82 four years ago – in the time since then she has lived a happy, healthy life and attended the college graduation of two granddaughters and the wedding of one. Was the expensive treatment worth it?
My wife was diagnosed with leukemia at the age of 50 – 8 years ago. The mean survival time for someone with her type of leukemia was estimated to be between 3 and 10 years. Last summer she was diagnosed with breast cancer. Aetna paid for top notch surgery and follow-up treatment at one of the finest cancer centers in the country. Under Obama care would the number crunchers decide that spending money on someone who statistically speaking should die within 2 years be worth treating? I’ll let you decide.
Leukemia has a inherited genetic predisposition associated with it. My daughter now has it coming from both sides of the family tree. Will the great deciders in DC decide that given her higher than normal chance of getting leukemia decide to ration all care for her in line with Ezechiel Emmanuel’s access to care curve? Who decides her “societal value” as an offset to her “societal (medical) costs” and tells her physicians whether she can be treated or not? Where do we go to appeal their decision?
Leukemia treatments and cures? It is a boutique disease that appears to be best treatable only on a personalized basis due to the unique genetic factors present in each victim. Will Obamacare fund development of “tunable drugs”? Yeah, right.
in_awe on August 16, 2010 at 1:49 PM
Mostly. I just disagree.
Esthier on August 16, 2010 at 1:57 PM
You forget the ultimate goal of PlaceboCare is to make sure that nobody except the government pays for anything health-care related (and that only the more-equal PIGs have access to anything beyond the basics).
steveegg on August 16, 2010 at 1:58 PM
Here’s the logic. If you’re going to die soon you aren’t going to be able to vote for them so just go ahead and die already. Now if you’re a pregnant illegal alien, by all mean, we’ll expend all available assets to insure you health and wellbeing. Democrats are WPOS!
TrickyDick on August 16, 2010 at 1:59 PM
Men get breast cancer at rates statistically identical to women. This affects us all equally.
Slowburn on August 16, 2010 at 2:02 PM
This is absolutely no surprise to anyone that has BEEN on Gub’mint Health Care for some time (Tricare).
Penny wise, pound foolish decisions are de riguer.
Had that one rammed home trying to get Chiantix, the stop smoking aid, for the wife. They’d rather let her slip into full blown emphysema, or lung cancer, than shell out for a short term, but somewhat pricey fix. Even after her primary physician got into a pissing contest with them because she has early COPD, and has tried just about everything else, to no avail.
And don’t even ask your doc for a script if the problem is erectile dysfunction – NONE of the meds that the spam filters would whack in a heartbeat are covered. They flat out really don’t care if Mr. Winky will stand up and salute on cue.
Wind Rider on August 16, 2010 at 2:04 PM
‘
First, thanks for being rational. At some point, there has to be a cost-benefit analysis completed, no? We can’t afford every and all treatments for everybodyu, even in the best of times. If this panels’ sole reason for ditching Avastin was cost, then I’m with you all 100%. However, not one but TWO new studies suggest Avastin has “no life-extending capabilities.” Given that, don’t we have to question whether it’s worth the cost? How many studies showing no results would convince you? 5? 10? 20? 2 is a pretty good indication that it doesn’t work, I think.
‘
Look, my father died from prostate cancer 4 years ago next month so I know damn well how tough these decisions are. He had a type of cancer that disqualified him from all trials and studies, so we got lots of rejection letters and had to manage with chemo and the standard drugs. Thems the breaks.
‘
As is all too typical, he died from the side effects of the treatments rather than the actual cancer, which is why I mentioned the nasty side-effects of Avastin. In a healthy patient, blog clots and heart failure and such are readily treatable; in a cancer stricken patient whose immune system has been hammered by chemo, not-so-much. Remember, Avastin is a “last-ditch” effort for “advanced” cancer patients. My father’s last two months were filled with tear-inducing, agonizing pain. I wouldn’t wish another 2-3 months of that on anyone.
‘
You can disagree with me, but there’s no need for accusations of shilling and such. I readily concede that what the cost-benefit ratio should be and who should make that call is an open question with no good, easy answers. But you all should at least concede that if a drug doesn’t work in a vast majority of patients and it costs $55K a pop, maybe we ought to take another look at it.
‘
As for the effect on investment and R&D, I see little impact. Drugs get knocked down by the FDA all the time; that’s one of the reasons experimental drugs are so expensive. There’s always a risk that a company will spend billions on R&D and end up with nothing. I think price controls would have a much more detrimental effect on R&D and investment than an FDA finding that the drug doesn’t work.
rcpjr on August 16, 2010 at 2:04 PM
But I don’t believe this is the FDA’s job. The FDA determines if the drug is safe and works. Are they reviewing the drug to see whether it “works” 100% of the time? 20%? What is the acceptable level of working for FDA approval. Not all drugs work for all people. Some people are allergic to some drugs. Therefore, no drug can claim 100% effectiveness. the cost/benefit analysis is not FDA’s job.
As to the cost/benefit question, I see a lot of people writing on this site how we can’t put a value on a single day of life and nobody should be deprived this or any treatment.
I think we are falling into the trap of liberal thinking about insurance policies. We should not assume that every policy is going to cover every treatment. Insurers have to have the ability to deny treatments that have very little upside but that are incredibly expensive. If you want a policy that has no limit on potential treatments, you should pay a lot more in premiums.
Let us not forget that “health insurance” is not simply “pay all of my bills” – that is liberal thinking. Health insurance is supposed to be about risk sharing. That means at the end of the day the insurance company has hopefully spread the risk out such that it makes some money off of all the premiums after all the pay-outs. If we start thinking like liberals and demand that all insurance, including medicaid and medicare, cover every single treatment, regardless of any cost/benefit analysis, we are buying into the liberal fantasy that their is a free pot of money out there that will take care of all of our medical care needs.
For the system to work, some policies will cover X, some policies will cover Y, and some people will end up in situations where their coverage does not cover some really expensive or experimental treatment that they want or need. Of course, in our current system those individuals are free to obtain the money for such procedures / drugs through charity, etc.
However, if we cannot, as conservatives, accept those limitations on health care insurance coverage, than we may as well be for universal care b/c regulations mandating coverage of everything for everyone will surely put insurers all out of business leaving only the gov’t to turn to.
Monkeytoe on August 16, 2010 at 2:16 PM
There is a lot of tweaking that could be done on all sides. I will be on medication for the next five years. Through a regular pharmacy a thirty day supply with my excellent insurance cover of 3/4 off was $107. A ninety day supply through a mail order system was $65. On my third refill the medication became available as a generic, cost to me for 90 days is now zero. How stupid is that? I realize that I should be thrilled because our premiums are not cheap but I would be paying those regardless. If I had gotten a decrease in the generic but still paid something to help average out the costs it would make more sense.
Cindy Munford on August 16, 2010 at 2:21 PM
Do you think it is less advertised because there are either no or lower reconstructive costs?
Cindy Munford on August 16, 2010 at 2:22 PM
It’s called an oxymoron for a reason…all moron’s need is a little oxygen to survive.
Hint: “Facts” and “Suspect” are not synonymous.
I work of facts, and the fact is your post is extremely idiotic.
right2bright on August 16, 2010 at 2:23 PM
I don’t disagree if they are looking at the drug’s effectiveness. But in the article, they were specifically talking about cost/benefit – which is not the FDA’s job. The FDA is meant to note whether the drug is safe and whether it works. Now, as to what constitutes “works” in this context, I don’t know enough. As long as they define it the same way they define it for every other drug and do not take cost into account, then no problem with a review. Again, the cost is not FDA’s job, and using the FDA to disapprove a drug based on cost is simply a way to avoid the hard decisions that have to be made by Medicare, Medicaid, or various Insurance companies. If a drug is safe and saves the lives of 90% of people who took it, but cost $10 million a pop, the FDA should still approve the drug b/c it works and is safe. It is not FDA’s mission to debate the cost of the drug.
If Medicare came out and said that based on cost/benefit, they would not cover the drug, I would have no problem, as that is likely a rational decision.
Monkeytoe on August 16, 2010 at 2:24 PM
Obama’s administration … simply …
hates … women!
Phil-351 on August 16, 2010 at 2:24 PM
This is a completely different topic. You’re talking about an insurance company not paying for an available treatment. This story is about a drug being removed from the market by the FDA because its “too expensive”.
Whats next…the Mercedes 350SL? “It’s too expensive, therefore the government says no one can buy it”.
BobMbx on August 16, 2010 at 2:25 PM
They are not death panels.
They are Obama Wellness Transition Seminars.
Dhuka on August 16, 2010 at 2:27 PM
You still haven’t overcome the fact that the FDA approved the drug, and now wants to unapprove it.
They must not have been aware that this drug is crap when they approved it.
BobMbx on August 16, 2010 at 2:29 PM
They are taking away the right of a patient to pay out of pocket for a treatment they want. This is the great leveler, the great equalizer. If patient A is too poor to afford a drug and the government doesn’t want to pay for it, patient B who is rich shall not be allowed access to that drug either.
It is a death panel.
Greyledge Gal on August 16, 2010 at 2:29 PM
If you read my whole comment, I agree that the cost/benefit analysis is not the FDA’s job. I would think that such analysis would be Medicare / Medicaid’s job in deciding what that covers – much like any insurer.
I was just commenting on the many comments that seemed to imply that there is a right to any treatment. I see far too many people, even here on the right, who confuse “health insurance” for some fantasy pot of money to pay any and all medical expenses with no cost/benefit analysis.
I agree that gov’t should not be making these decisions, and that Obamacare is a nightmare that will lead to the gov’t rationing ever more care.
But we have to remember that these cost/benefit decisions do have to be made. I want the free market to make them. Insurer X can offer a top of the line policy that covers every treatment under the sun, and people who can afford that can get it. Insurer Y offers more modest coverage, and some people purchase that. And so on.
And, as always happens, over time the new treatments become cheaper and the modest policies start to cover them. the free market works.
But there appears to be a general feeling, even on the right, that every policy should cover every experimental treatment/drug. That is simply not feasible. Some people, likely myself included, are simply going to have to go without the experimental / brand new treatments and drugs if we get sick b/c our policies don’t cover them.
Monkeytoe on August 16, 2010 at 2:35 PM
Withdrawing the approval for treatment of breast cancer doesn’t mean the drug is taken off the market. Doctors can still prescribe it off-label.
My emphasis.
Avastin doesn’t extend the lives of patients nor does it improve their quality of life. Beating back cancer growth while enduring the side-effects from the drug’s toxicity is somewhat of a Pyrrhic victory.
year_of_the_dingo on August 16, 2010 at 2:45 PM
Rush just told a story from the NYT about a person who is a big contributor to the Democrats getting a waiver from the FDA to allow a drug to used in an other than approved application. So the non existent Death Panels may be swayed by political affiliation?
Cindy Munford on August 16, 2010 at 2:46 PM
We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost.
— B. Hussein Obama, January 21, 2009
So, demanding reversal of a science-based decision is how science is restored? Who knew?
ya2daup on August 16, 2010 at 2:49 PM
Avastin is a product of Genentech, a member of the Roche Group.
There is about $1 billion and 7 millon man-hours invested in Avastin.
J_Crater on August 16, 2010 at 2:53 PM
How can you state that when there is a lady in the article who has been on it for eight months and doctors says that it helps a certain group of women. The “group” isn’t big enough for you?
Cindy Munford on August 16, 2010 at 2:56 PM
OBAMACARE DEATH PANEL DECISION GUIDE
(condensed version):
Is the treatment less expensive than a bullet?
landlines on August 16, 2010 at 2:58 PM
Men, don’t get nut cancer. We’ll be next.
madmonkphotog on August 16, 2010 at 3:01 PM
Oh, don’t worry, they are already promoting the idea that most man will die of something else before their confirmed diagnoses of prostrate cancer so there is no need for treatment. Now I wonder if that’s the truth or just another cost cutting ploy.
Cindy Munford on August 16, 2010 at 3:10 PM
Unbelievable and creepy.
When I shared this on facebook, the pictographic verification text thingy was “union embalmer”. You can’t make this stuff up. I took a picture b/c who would believe that?
shibumiglass on August 16, 2010 at 3:17 PM
To borrow a headline from the late 70s NY Times:
FDA TO WOMEN: DROP DEAD
TugboatPhil on August 16, 2010 at 3:25 PM
“About one percent of breast cancer develops in males.”
Do you have a reference that suggests that male breast cancer account for 50% of incidents?
Dubya Bee on August 16, 2010 at 3:27 PM
Where are you getting 55K a pop?
There are plenty of sick folks who routinely have medical bills of 8,000k a month covering doctor visits, hospital care, drugs etc.
There are pregnant women who have dangerous pregnancies/ emergency deliveries, hospital care, NICU baby hospital care etc that can run into the hundreds of thousands of dollars.
There are wives and husbands trying to have kids whose fertility treatments, necessary surgeries run into the thousands of dollars- many treated at public university clinics and sometimes for free.
Are you going to cut off their care too?
journeyintothewhirlwind on August 16, 2010 at 3:28 PM
Dang it:
http://en.wikipedia.org/wiki/Male_breast_cancer
Dubya Bee on August 16, 2010 at 3:28 PM
Didn’t someone warn us before that Abomination of care was passed that they were doing this across the pond with the NICE-death panels?
Chip on August 16, 2010 at 3:31 PM
This is the Obama Paradox, isn’t it? He says (with one fork of the tongue) that everyone will have insurance, and everyone will pay for it.
With the other fork, he says (much more softly and through the various agencies he controls) there is no right to healthcare, except as determined by the death panels.
So yes, everyone will have insurance, but the government makes no gaurantee of care.
Wait ’til the libs find out that everyone can’t afford the 45′ Country Coach RV. Just think of the horror and the inequality of that. Some people will have to go camping in a tent for God’s sake, or not go camping at all!
How dare those people who can afford expensive items actually use them, while others can’t. It just not fair, mommy.
BobMbx on August 16, 2010 at 3:44 PM
It doesn’t matter that the AGW facts are all jazzed up. I like what it says, and it gives me a hook to impose a carbon tax on the little people.
Money. Its a gas.
BobMbx on August 16, 2010 at 3:47 PM
Folks, there is not an unlimited amount of money to spend on medical care…………… and, I am not an Obama supporter.
SC.Charlie on August 16, 2010 at 3:50 PM
That isn’t the debate.
Cindy Munford on August 16, 2010 at 3:52 PM
Life threatens the marxists’ ability to live in splendor.
They must control it.
notagool on August 16, 2010 at 3:54 PM
The FDA approved Avastin for the treatment of breast cancer in 2008, against the divided recommendation of its advisory board. Clinical trials showed that it shrank tumors, but it didn’t prolong life or improve quality of life. Many private insurance companies already decline coverage of the treatment, ostensibly for those reasons. Despite the controversy, it was probably pushed through with the well-meaning influence of breast cancer advocacy groups. It will likely keep its status because of the well-meaning influence of those same groups.
This was a political decision then and will be a political decision again. It’s probably sexier to oppose Obamacare because of some shadowy panel of bean counters deciding who lives and who dies, but it’s just as valid to question whether the government will have the detachment necessary to make necessary, difficult decisions to deny coverage.
RightOFLeft on August 16, 2010 at 4:21 PM
Again, this is conflating two issues. One issue is whether or not the drug is effective and safe – to whatever degree is the norm for FDA approval.
The second question is whether the benefits of the drug are outweighed by its costs.
the 1st question is appropriate for the FDA. The second question is not something I want the gov’t to decide. I want the free market to decide by offering different options at different prices for insurance coverage. With that said, b/c we are stuck with medicaid and medicare, it is appropriate FOR THOSE AGENCIES to make cost/benefit decisions as to their coverage.
it is not, however, appropriate for the FDA to make those cost/benefit decisions. And, with Obamacare, we are likely to see the gov’t involved in more and more of these decisions. And, b/c the gov’t wants a 1 size fits all coverage regime, that means nobody will be able to get certain treatments that the gov’t decides are not cost effective. And, once the free market for health insurance is destroyed by Obamacare, b/c the gov’t is much less efficient, there will be many, many, many more drugs/procedures that are found to be not cost effective than would occur in a free market.
Monkeytoe on August 16, 2010 at 4:54 PM
You may have not meant it this way, but you have to watch it when making reference to money as though it is a Collective instrument, as though the way “wealth” is spent is the purview of a central authority like the government.
The Conservative viewpoint is that the way money is spent, it is the purview of the individual.
You could say the same thing about any product or need – as in:
Folks, there is not an unlimited amount of money to spend on Housing
Folks, there is not an unlimited amount of money to spend on Food
Folks, there is not an unlimited amount of money to spend on transportation.
The implication of that kind of statement is that there is a shortage of money to be spent in a specific area, and therefore there has be a central authority that needs to step in and “Ration” this money.
Was it you intention to imply this?
Chip on August 16, 2010 at 4:58 PM
Why is the government involved in this decision in the first place? From what clause in the Constitution does the authority for this decision come from? And if only they had the detachment necessary to 1) protect our borders, 2) actively look for and prosecute fraud within the social programs that already exist, 3) bomb the shit out of our self-proclaimed enemies, etc…
From your phrasing, it seems you’ve given the government permission to make this decision for you.
I have not.
This, then, is the entire argument surrounding ObamaCare.
BobMbx on August 16, 2010 at 5:02 PM
But there seems to be an unlimited amount of money to get re-elected.
BobMbx on August 16, 2010 at 5:04 PM
The article states that the concerned woman was 48. Why was she getting Medicare, or is this just lazy journalism?
txmomof6 on August 16, 2010 at 5:12 PM
Well, guess what? The women who died after taking Avastin weren’t available for interview. It’s a real pity that they didn’t know that they don’t belong to this a certain group.
year_of_the_dingo on August 16, 2010 at 5:18 PM
Cancer is not a great thing to hear and treatments vary. So there will always be “groups” that do and don’t benefit. Equality in opportunity is bad enough but you demand equality in outcome. I pray that you never need to be outside the statistics. Again, we are not talking about mandating insurance companies or Medicare/Medicaid using the drug, just that it remain an option. Why do you have a problem with that.
Cindy Munford on August 16, 2010 at 5:35 PM
I didn’t read that she was on Medicare, but I could have misread it.
Cindy Munford on August 16, 2010 at 5:39 PM
My husband’s comment when I yelled the details to him across the room:
“Well, there goes the women’s vote for the Dems.”
We can only hope.
Animator Girl on August 16, 2010 at 6:06 PM
Since 1992 I have said one thing when it comes to health care and the costs.
“I would rather have a system that keeps inventing cutting edge care and medications I can’t afford now but could in 5 years instead of one that discourages that innovation.”
I was always told that wouldn’t happen. Welll……
LifeTrek on August 16, 2010 at 6:39 PM
+ One trillion.
Cindy Munford on August 16, 2010 at 6:40 PM
Maybe they weren’t available because cancer killed them?
That’s like saying a person shouldn’t go for open heart surgery because the odds of him dying are much more then a healthy person….
right2bright on August 16, 2010 at 7:02 PM
I wasn’t clear enough that I was talking about two separate issues. First, the politicized approval of Avastin for breast cancer treatment. Ed is wrong that it’s up for the chopping block over cost concerns. There have been concerns over the effectiveness of the drug from the beginning.
Second, I believe that if we’re going to have government-run insurance — which you explained how it isn’t insurance at all — then the fiscally conservative thing to do is not to cover long-shot therapies.
Basically, I’m saying that death panels are the opposite of the real problem with Obamacare. Everyone seems to be jumping on this example, which hasn’t even happened yet, as vindication of Sarah Palin. But watch the drug get approved by the FDA because the Democrats don’t want to have to watch ads about how they’re against treating breast cancer. The government — and every government agency will have to be involved — is going to find excuses to cover things that any insurance company that wanted to stay in business would have to charge more for.
RightOFLeft on August 16, 2010 at 7:29 PM
Also, don’t kid yourself that insurance companies aren’t lobbying right now to get the most expensive treatments’ FDA approval pulled. If only we had real health care reform, that addressed the worst practices of insurance companies without replacing them with the even worse practices of the government. But that would take compromise, and you probably couldn’t get it passed through a Republican or Democratic congress without reconciliation, so I’m not holding my breath.
RightOFLeft on August 16, 2010 at 7:34 PM
riiiight
The Democrat health care plan is this: If you’re rich enough, you live, if you’re poor, you die.
franksalterego on August 16, 2010 at 7:37 PM
They have already increased the age for mamograms; and now want to pull avastin. Yet ObamaCare will provide for abortions when a condom will provide the same result at a much cheaper cost.
TN Mom on August 16, 2010 at 11:15 PM
No, those who died during the Avastin trial died from heart failure. The drug has really serious side-effects. What kills the cancer cells kills the patient too. That’s no data suggesting that Avastin prolong the lives of breast cancer patients. It stops cancer growth, but it causes the perforation of the stomach among other things.
year_of_the_dingo on August 16, 2010 at 11:23 PM
Government insurance is being run into the ground by these Drug “companies”. It is obvious to anyone who cares to open their eyes that Medicare and cade are the proverbial “goose laying golden eggs”. It is time the feds said no deal on this type of cost and taxed these bastards into oblivion. Play ball or be gone….. 8 to 25 thousand a month for some cancer drugs…..BS
dartagnansblade on August 16, 2010 at 11:43 PM
Develop your own cancer drug?
Inanemergencydial on August 16, 2010 at 11:56 PM
It didn’t take long for the death panel to rear it’s ugly head.
Sorry your life is too expensive to save.
And we will rescind the drug altogether so you can’t buy it privately… that way there are no statistics to compare later.
petunia on August 17, 2010 at 12:14 AM
The Americans let their “federal” rulers take some $2 trillion from them per year, let them borrow some $1 trillion per year, lend them much of that money themselves, and then expect to tell their “federal” rulers they are not permitted to do just whatever the h3ll they want to do. If you give me $3,000,000,000,000 to spend this year, I assure you that you will not thereafter tell me what to do. It’s a tribute to Madison’s fine craftsmanship that you have any liberty at all left.
Kralizec on August 17, 2010 at 12:42 AM
Radiation treatment, 35 days, $2500 a day before insurance.
Cindy Munford on August 17, 2010 at 12:57 AM
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