and have been screwed by Obamacare. Of course, most everyone here at Redstate knew we were being lied to and will not be surprised by this.

Costs will go down, you can keep your own plan, no rationing, blah blah blah. All lies. And now they’re trying to take this drug off the market? I’m sure that this will be followed by banning other drugs that some bean counter determines is not cost effective. And then there are brand name prescriptions which I fully expect to be blacklisted in favor of generics, which, contrary to what some say, do *not* always work as well.

So to all those in Congress who voted for this debacle, may you be the first to be denied a drug that you need. Oh, I forgot. Congress is exempt from Obamacare. Is the FDA going to keep some of these drugs in reserve in case you need them?

issue. This is nothing more than rationing by the government, not about the efficacy of the drug. Organizations like the Komen Foundation and others need to formally protest this potential move.
One of my many concerns is that this rationing will spread to the population that I work with (I work in pediatric rehab). I do not want my patients denied adaptive equipment and/or medical treatment that could help them be more independent. But I fear that unless ObamaCare is repealed or struck down, this will be the case.

They want to decide who lives and dies based, not upon medical science, but upon saving a dime over a life.

Any way that our new Congressmen can fire these jerks next year?

I’m just curious what reason(s) FDA gave for this. Have there been many reports of death or illness resulting from the drug itself? Any lawsuits?

There were deaths, illnesses, and lawsuits two years ago from Chinese-tainted heparin, and the FDA didn’t seem to make such a stink about it. Isn’t heparin still available?

And if the FDA starts using cost as a consideration in the approval process, we can say hello to more “Chinese medicine,” literally.

Doesn’t it feel great to know the FDA is looking out for drug safety!

Elected officials and bureaucrats from the federal government regularly tell us how much they, we, spend on health care and will increasingly try to justify cutting back on drugs, Avastin, and other treatments in order to save money.

Does the federal government care how much we pay for clothing or iPods, or music, or televisions, or wood, or tens of thousands of other products? No. Why? Because they aren’t in those markets. If the federal government wants to stop worrying about the price of medical care then we need to get the federal government entirely out of the health care market. No involvement whatsoever. Then, and only then, will we be free from their worries about cost and free from the machinations of the meddling Marxists.

Why take the drug away from patients who benefit from it? Why effectively sign their certifiactes? It works, it’s available, and it is obviously paid for somehow by the patient, so why meddle at all?

they can, for no reason other than to make money. Same with doctors prescribing medications.

This discussion desperately needs some facts:

1) The FDA granted Avastin its first temporary approval for ADVANCED breast cancer in 2007, after researchers showed that patients on a regimen that included the drug showed an improvement in progression free survival.FFollow-up studies by the company showed NO BENEFIT It does not cure cancer, the majority of these patient will not live more than a few years.

2) Avastin costs $100,000 a year.

3) The drug will not be pulled off the market, it’s initial approval was for colon cancer, and will still be available for breast cancer as an off-label use.

4) Fatal reactions to the drug were seen in 2% of patients.

So the drug costs $100,000/year but hasn’t been shown to improve survival. Progression free survival sometimes is meaningful, but sometimes is a statistic trick drug co.s use to win approval.

If your Mom had terminal breast cancer with a prognosis of 1-5 years, how many of you would be willing to pony up the $100,000-$500,000 for a drug that kills 2% of the people that take it and doesn’t help?

and have no medical education in order to be able to make an educated decision about who is right or wrong.

That being said, the fact that the FDA seems to be considering cost in their decision which is a violation of their own rules scares me. Due to an accident on a 4 wheeler that left me nearly blind, massive damage to my liver, kidneys, stomach, and heart along with an injury to my brain that leaves me prone to strokes, the cost of my medication runs well past the 4000 a month it takes to pay for this drug. If my insurance cut me off, I would have no other option but to sit back in my recliner and wait for death. And it would come quickly.

This is Obama’s new tactic, which the left has been talking about for six months or more. They will push every limit of regulation, in effect ruling by fiat.

“”If you try to take away one bit of medical care from my mother, you zealous nut, you will have to physically come past me to do it.”"”

Okay then. If you try take the food out of my children’s mouths to keep your mother in gov’t medical care, you zealous nut, you will have to physically come past me to do it.

You want to keep old granny going until the bitter end with all possible technologies, meds, etc. you’d best be willing to pay for it, son.

The elders and sickly of this country are eating the productive young thru this medical insanity called medicare/caid.

Reasonable help given is one thing. Enslaving the next generation, quite another.

Death comes to us all. There is no avoiding it.

Hey, Lizabtha, what about the unproductive young? Like all the little children in St. Jude’s Hospital and other children’s hospitals around this country who are fighting a daily battle for their lives, which many of them lose. You want to cut them off too so there is more money for the so-called *productive* young, since these little unproductive ones are going to die anyway?

In my time here at Redstate, I don’t think I have ever read a more heartless post. Anyone want to join me in a money bomb to get this hateful human being a one-way ticket out of here?

P.S. I’m grateful I’m not *your* mother. I would advise her to watch her back.

Avastin is not a lifesaving drug in the case of metastatic breast cancer. It may have some benefit in morbidity, but not mortality. What NICE is saying is that it is not worth the cost of extending life in other metastatic cancers where it does have proven extension of life. THAT is a “death panel” decision. What the FDA is doing in this case is removing an unwarranted indication where there is questionable benefit that has not been proven to outweigh the risk.

If government is to pay for health care, naturally it has to cut somewhere and cut some people off – there’s not enough money to pay for everything anybody could possibly ever want, or even need.

Which of course is why government should not be paying for people’s healthcare, they and their families should do it themselves in accordance with their own beliefs, decisions, and priorities. Unfortunately we left that world a long time ago and it’s a long way back.

I’m a cancer researcher with colleagues and close friends in the clinic who treat cancer patients. And the thing about Avastin is that the average lifespan increase of treating with Avastin is about 2 months…and a significant amount of that time is spent in the clinic, hooked up to a line of Avastin. Very little time is actually gained. For this benefit, a single course costs $55,000 a year before the clinic markup, which most insurance companies will only pay 2/3 to 3/4 of, if you have insurance.

I would never advocate that the FDA take the drug away. There is a very small segment of the population for which the drug can work wonders (the problem being that no one yet knows how to predict this in advance), and even if there wasn’t, if a person chooses to spend that much money for such a modest benefit, it’s their choice. As for “limiting access”, I think again the decision needs to be between patients and doctors. But at this point, many doctors I know get a lot of pressure from pharmaceutical companies to recommend the drugs that have the highest profit margins, regardless of whether there will actually be a benefit in that case. For example, gleevec is coming off patent soon, and I know a doctor who is being pressured to badmouth the current drug to foreign doctors to get them to buy the new version that will be on patent for a long time yet. The same thing happens with Avastin in that a lot of people for whom there would be little to no benefit, and who might be better off spending time with their families without more side effects if that’s what they value, aren’t accurately informed of the situation so they can make their own choices. It’s “Avastin will give you x” without an actual discussion of the benefits vs. drawbacks so the patient can make an informed decision. And often when if becomes clear that the patient is not one of the few for whom the drug will be extremely effective, there is little in the way of reevaluation of the treatment plan.

So if the FDA report is going to offer guidelines that might cut down on that and make sure patients are informed so they can make choices for themselves, I can’t say I would be against that. But if they’re actually going to try to restrict the drug, I absolutely disagree. If a patient (or their insurance) can pay for it, and they think it’s worth it, or if they’re in the small percentage of patients for whom it works extremely well, it’s their decision.