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Posted at 11:12 AM ET, 12/16/2010

FDA begins process of revoking Avastin approval for breast cancer treatment

By Rob Stein

The U.S. Food and Drug Administration has begun the process of revoking approval of Avastin to treat advanced breast cancer

Federal officials say new evidence indicates the risks do not outweigh the benefits of Avastin for treating metastatic breast cancer.

Note: The above should have stated: Federal officials say new evidence indicates the benefits do not outweigh the risks of Avastin for treating metastatic breast cancer.

By Rob Stein  | December 16, 2010; 11:12 AM ET
 
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Comments

Don't you mean the benefits don't outweigh the risks?

Posted by: mleditor | December 16, 2010 11:30 AM | Report abuse

Surely you must mean that the risks outweigh the benefits? If the risks don't outweigh the benefits, as you have written, why are they moving to revoke? Especially given the poor prognosis for metastatic breast cancer it seems difficult to understand.

Posted by: alaporte | December 16, 2010 11:30 AM | Report abuse

How did you let a typo like that slip by!? Talk about messing with the minds of women (and men) who are already ill and those who love them!

Posted by: ruralgoddess | December 16, 2010 11:34 AM | Report abuse

The benefits do not justify the cost. Each treatment is $13,500 -- estimated yearly cost $100,000 to $500,000. It supposedly buys a little quality of life in those with late-stage breast cancer and maybe buys an extra 5-1/2 months of life.

We cannot afford to do this.

Posted by: mcdojh | December 16, 2010 11:41 AM | Report abuse

How did you let a typo like that slip by!? Talk about messing with the minds of women (and men) who are already ill and those who love them!

Or may be the cost are to high for Avastin...Death panel anyone?

Posted by: HarlinJHendricks | December 16, 2010 11:44 AM | Report abuse

Curious to know if the FDA will arrive at a similar conclusion for lung cancer patients. I believe Avastin is considered a great maintenance drug for those with lung cancer.

Posted by: BuckeyeGuy | December 16, 2010 11:48 AM | Report abuse

mcdojh wrote "We cannot afford to do this."

I wonder if you'd feel the same way if you had breast cancer and this were the only drug that helped.

Posted by: SupportAndDefendTheConstitution | December 16, 2010 11:51 AM | Report abuse

If mleditor could read English, he/she would know that there is more than one way to state that the risks are greater than the benefit....in this case, the Avastin has greater risk to a patient than it has benefit; or, it has less benefit than the risks which may follow. Capis?

That being said, it is long past time that the FDA and other agencies ensure that an active ingredient be more strenuously tested and have far more data reviewed before permitting a drug to be available to a patient. Europe does this, as does Canada. As they say: an ounce of prevention is worth a pound of cure.

There may never be a cure for cancer, but we who are unlucky enough to have it need to be confident that what a physician is giving us as treatment is as safe as it can be under the circumstances. When the risks of a drug outweigh the benefits, it should not be given to anyone, unless that person has been advised of the greater risk! And the person who is undergoing treament should be wise enough to do research on the drugs or other treatments being proposed.


Posted by: GazelleDZ | December 16, 2010 11:53 AM | Report abuse

And the people that have cancer and it is helping, what happens to them? No one seems to be addressing that issue. Even if it means only a few more "quality of life" months, does the FDA really have a right to say those months are of no value. I'd be willing to sign a waiver to never sue to continue using it if it helps. Why are real lives never taken into consideration when these decisions are made -- this is disgusting!!!!

Posted by: Ginger01 | December 16, 2010 12:00 PM | Report abuse

And the people that have cancer and it is helping, what happens to them? No one seems to be addressing that issue. Even if it means only a few more "quality of life" months, does the FDA really have a right to say those months are of no value. I'd be willing to sign a waiver to never sue to continue using it if it helps. Why are real lives never taken into consideration when these decisions are made -- this is disgusting!!!!

Posted by: Ginger01 | December 16, 2010 12:00 PM | Report abuse

I'm inclined to beleive that this is NOT a typo. The FDA has done this before, removed an item from the market without sufficient cause. Many of us feel strongly that the FDA is in serious need of reform. In the case of cancer patients, they seem to be doing more harm than good.

Posted by: JupiterLady | December 16, 2010 12:11 PM | Report abuse

No, they indeed mean "risks do not outweigh the benefits". That's how they make their money :P

Posted by: gsc4077 | December 16, 2010 12:13 PM | Report abuse

GazelleDZ, mleditor's reading and comment are perfectly correct. "risks do not outweigh the benefits" is NOT another way to say "risks are greater than the benefits.

Posted by: douglasmarshall | December 16, 2010 12:34 PM | Report abuse

DEATH PANEL

sooner than we thought

What do they recommend? A cheap euthanasia?

Posted by: jbg29 | December 16, 2010 12:34 PM | Report abuse

Before you all get carried away with speculation about death panels or that the cost of the treatment had anything to do with FDA's action, read this from the WSJ -

"The FDA says “the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” Risks include severe hypertension, bleeding, perforations in various body parts and heart attack or heart failure, the agency says."

It's about the HEALTH risks of Avastin versus the HEALTH benefits. This is what the FDA is for - to determine if drugs have provable benefits and don't cause more problems than they solve.

By the way, they did not take action on Avastin for use in other cancers, like colon cancer. Perhaps in that case, the demonstrable benefit of reducing the spread of the cancer was greater and thus worth the risks.

Posted by: Tigerbomb | December 16, 2010 12:38 PM | Report abuse

Hey--mleditor is right! However, I'd suggest that since a number of comments here posted here were "wrong" perhaps the sentence should/could have been rewritten/edited to be more immediately clear so that they would not not not be misunderstood. A triple negative. Who would have thunk?

Posted by: ruralgoddess | December 16, 2010 12:42 PM | Report abuse

SUCCINT but with a LACK of ATTENTION TO DETAIL! Two sentences which taken together DO NOT MAKE SENSE. Plus, no additional explanation/commentary from Mr. Stein? LACK of PROOFREADING/COPYEDITING, etc. of BLOGS & BLOGGERS... perhaps the embarassment will avoid a repeat of such a FAUX PAS?

Back to the subject at hand, I suggest EVERYONE go DIRECTLY TO THE HORSE'S MOUTH.... read the FDA News Release...

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm

I will take the liberty to post the TITLE, and the FIRST TWO paragraphs of the FDA News Release (dated Dec. 16, 2010):

"FDA begins process to remove breast cancer indication from Avastin label"
"Drug not shown to be safe and effective in breast cancer patients"

"The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use."

"The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure."

Thus, the BENEFITS of AVASTIN DON'T outweigh the RISKS - for breast cancer treatment.

Posted by: grbobf | December 16, 2010 1:21 PM | Report abuse

TigerBomb is correct, Avastin does have a strong track record in other types of cancer. My sister thankfully received Avastin as part of her stage IV colon cancer treatment last year. Despite severe liver metaphases, she is now 'cancer free' 9 months post chemo. The other key to her survival was starting chemo immediately to hopefully stamp out the micro-metaphases prior to the surgical excision. Thank God and Dana-Farber!

Also, I am a medical device regulator for the EU. It was a typo but mistakes happen unfortunately. The entire basis for most medical regulatory systems is that the "benefits to the patient must outweigh the risks"...this is an intricate concept and not always as clear as one would hope when not wanting withhold possibly lifesaving but cutting edge treatments and technology.

My prayers are with those who are living with and healing from cancer.

Posted by: ksr7493 | December 16, 2010 2:27 PM | Report abuse

My father died last July of Glioblastoma brain cancer. Honestly, he had very little hope of recovery and his death was more or less a given. Still, he was a fighter. Avastin was the "new thing." Works on the premise of stopping new blood vessel growth...which generally only happens, in adults, with injury or cancer. The former is the issue. Forgetting the cost for a minute, my father had unfortunately been irradiated for prostate cancer, which was cured. Unfortunately, the radiation fried his colon. He was asymptomatic. No issues. However, once he went on Avastin for the brain cancer, the minor damage to his colon became a hole from his bladder to his colon. Since he was destined to die anyway, Avastin just made him suffer more. I have no idea what he was or wasn't told about this drug, but I think using it to prolong life is a mistake in most instances. Since it is impossible to detect minor "irritations" within the body that can worsen, as was the case with my father, I have to agree with the FDA. Besides, Avastin is NOT something you can be on for a lifetime...regardless of cost. While some may get more time, many will suffer and none will be cured. For my part, I think we need to stop spending so much money on delaying inevitable death and focus more on early detection. Before you ask...YES...I would feel the same if it were me. In fact, I have drafted legal documents to insure such action is NOT taken if I become terminally ill with cancer. While I truly understand the desire to live longer, I would rather others never get to the point my father reached...curled up in a fetal position, unable to urinate without help, unable to do ANYTHING without help, unaware of who he was or WHERE he was. Brain cancer...the one we know the least about, is the worst. Give me any other form if I can cut it out and still be me! If you have ever cared for someone with brain cancer, as I did, you know what I am talking about. Also, be wary of radiation! You only have so much lifetime exposure you can take. Save it for your brain if you can! You can live without a leg, but when someone carves out a big chunk of your brain...you are not YOU any more!

Posted by: NeoStrom | December 16, 2010 2:34 PM | Report abuse

Well, that's one way to cut costs and expenditures from the national treasury and at the same time allow earlier deaths cut the amount of social security benefits paid out. Obamacare at its' optimum benefit to "the society".

Posted by: GordonShumway | December 16, 2010 3:35 PM | Report abuse

Maybe the Obama administration just wants to see women die.

Posted by: Embiggen | December 16, 2010 4:29 PM | Report abuse

I truly wish that we as consumers would see the ruse that is behind BIG PHARMA'S garbage. It is nothing more than a crutch. Like going to a doctor with a broken leg, and getting only a set of crutches. Does nothing to heal the broken leg.

Our FDA gets the bulk of it's money from BIG PHARMA, thus we have no independant review as to the effectiveness of these pills. To few of us know just how this process works, and too many of us are afraid to seek the knowledge, as to just what we are taking for what ails us.

As for cancer unless we go the way of the AMA, poison, as in chemo-therapy, slice, or burn as in radiation, we are scorned. Just look at the aftermath of our using the atomic bomb on Japan to understand how backwards it is to use radiation to try to cure cancer.

Chemo-therapy will likely kill you before the cancer does. If any of you has seen a loved one on chemo-therapy, you have an idea what I mean. The truth is out there people we just have to be willing to look for solutions, that do not include goobs of money, because after all if we do the basics, exercise, good diet, that does not include processed food, but does include at least 80% raw fresh non GMO fruits and vegatables, proper hydration, with clean water, proper sun exposure, a good spiritual posture, and proper rest. Our bodies can heal themselves.

We must be willing to research just what all of this means. We need to understand just how bad a toxin aluminium is, and understand just what risk most household cleaners present to our health. Doctors are after all the 3rd leading cause of death in America. Not my words, but they can be found in JAMA. Google the 3rd leading cause of death in America.

Posted by: Fedup77 | December 16, 2010 9:00 PM | Report abuse

Cancer is a despicable, cruel disease. I've seen a family member die of cancer. He took the most aggressive treatment course possible. His doctor seemed optimistic, but there really wasn't any hope at all (which I learned from statistics online and from another doctor). They drilled a hole in his head. The site got infected so they had to do it twice. They were constantly giving him spinal taps to see if the treatment was working (it wasn't). He went to a hospice a few days before he died, at that point in a coma. I don't believe the "treatment" was worth it.

Do you really think every cancer drug out there is effective? Is "treatment" always the best course of action? Is doing "something better than nothing" or would it be better to treat the symptoms, not the disease in order to improve quality of life? Money aside, is everyone expected to "fight" cancer, no matter the side effects, loss of dignity, and emotional consequences?

Posted by: kimk1 | December 17, 2010 9:45 AM | Report abuse

"I know of no manner of speaking so offensive as that of giving praise, and closing it with an exception."
-Richard Steele
All I have done is my determination. So why do we blame the insiders of Iran and Iraq. UK has failed in the mission and Bush failed in this too. Obama has the empty treasury and wonders how he can if he can re coupe the losses. Definitely not by funding Pakistan. That was, Now the history has changes altogether. Fund the poor the sightless. That I think is better then cash dishing to the riches that never reaches the poor See Tanzania for example. Poor are still poor If that is life so be it. I thank you Firozali A.Mulla DBA
I thank you Firozali A.Mulla DBA

Posted by: flymulla | December 17, 2010 10:20 AM | Report abuse

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