FDA rejects Avastin for use against metastatic breast cancer
November 18th, 2011
02:03 PM ET

FDA rejects Avastin for use against metastatic breast cancer

The Food and Drug Administration announced Friday that it was revoking its approval of the drug Avastin for metastatic breast cancer after concluding that it has not been shown to be safe and effective for that use.

"The FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use," said FDA Commissioner Margaret Hamburg, who made the announcement.

“As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment, but after reviewing the available studies," she said, there is no evidence that Avastin does "help women with metastatic breast cancer live longer or improve their quality of life."

The FDA’s decision removes the use of Avastin in combination with the cancer drug paclitaxel for women who had not been treated with chemotherapy for the form of metastatic breast cancer known as HER2 negative. The removal is based on extensive records, which include thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing in June 2011, as well testimony from a hearing on the drug held in December of last year.

Avastin went through an accelerated approval process so it could go to women who needed treatment. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. The data showed only a small effect on tumor growth without showing that patients  lived any longer or had a better quality of life, compared  with taking standard chemotherapy.

“We found after rigorous testing the side effects of Avastin were more damaging than the benefits,” Hamburg said.

Tests showed that side effects from the drug included bleeding, hemorrhaging, chance of heart failure or heart attack and high blood pressure, as well as perforation of the body, including the stomach, nose and intestines.

Although the drug has been deemed “unsafe,” many women on Avastin swear by it and say it has made a difference in their lives. Although Avastin will still be available once the FDA removes the approval, it will no longer be covered by insurance for use against breast cancer, and that’s a main concern with patients.

“The FDA doesn’t regulate the practice of medicine,” Hamburg said. “It is up to a patient and doctor to discuss the risks and benefits."

In a written response, Genentech said, “We are disappointed with this outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment.”

The statement continued, “Despite today’s action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.”

When asked if the FDA would reconsider Avastin for metastatic breast cancer if more tests from Genentech found it to be safe and effective, Hamburg was open to discussion.

“We will work with Genentech on this issue,” she said. “But for now, this is our decision.”

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancers.

soundoff (367 Responses)
  1. BillRubin

    So it's a drug-sponsored study that did NOT show any benefit of the drug. If there was a "big-pharma" influence, shouldn't the results say the opposite? I thought drug-sponsored studies are all a big conspiracy, but this study doesn't jive with that.

    November 18, 2011 at 17:27 | Report abuse | Reply
    • BillRubin

      I'm being sarcastic btw

      November 18, 2011 at 17:28 | Report abuse |
    • Joe

      I work in the biotech industry in global compliance. Any accusations of there being a conspiracy between the companies and the FDA is waaaay overblown. We're constantly expected. We receive constant threat letters for violations from the FDA and a host of other world-wide government health regulators. There is no conspiracy. We are the most regulated industry in the world, and the most closely scrutinized.

      November 18, 2011 at 17:44 | Report abuse |
    • vman2003

      Or another "big pharma" paid more for it not to be approved. Either way FDA should absolutely have no say in what medications they should approve – the patients should. It is abhorrent to me that there may be women out there with this horrible disease for whom this drug works (read the article – "Although the drug has been deemed “unsafe,” many women on Avastin swear by it and say it has made a difference in their lives.") and FDA is basically pulling the rug under them. It is ultiimately up to the patient to decide what drugs they should be taking, according to how their body reacts to it. Not up to some worthless bureaucrat.

      November 18, 2011 at 17:44 | Report abuse |
    • Li Tai Fang

      Or "big insurance" influence: "we don't want to pay for that drug. Don't approve it!"

      November 18, 2011 at 17:54 | Report abuse |
    • Michael

      Despite the sarcasm, it is worth noting that the study and drug are from Genentech. It's a biotech company, not big-pharma. Before Roche bought them, they were unique and committed to the patients. If you ever drove through their campus (before Roche), you would see patient pictures and testimonials everywhere. You, literally, could not go through their campus (no, I do/did not work there) without seeing the patients that were being affected by the cancers and treated with their drugs. And no, these were not for the public, as the campus is pretty isolated.

      Yes, now that Roche owns them wholly, they could be considered a part of big-pharma. But the people I know that work there despise that term and its connotation of profits before patients.

      November 18, 2011 at 18:17 | Report abuse |
    • Portland tony

      From what I read, Medicare is covering it for breast cancer treatment.

      November 18, 2011 at 18:20 | Report abuse |
    • Nah

      li: "Or "big insurance" influence: "we don't want to pay for that drug. Don't approve it!""

      Right. Because that wouldn't be self defeating at all.

      That way when the company comes up with an approved product, the price of research and development for the other drug won't be rolled into the price of the new one. Not at all.

      November 18, 2011 at 18:21 | Report abuse |
    • Eric of Reseda

      @ Joe No offense Joe, but I'm not sure the regulators are doing a very good job of it. The drug industry has a monstrous history of putting drugs on the market that actually harm people. If you were so regulated, then why do drugs like, say, Vytorin, make it to market?

      November 18, 2011 at 22:53 | Report abuse |
    • cn

      if americans woke up and realized that there is no "one pill" that would solve all their problems, "big pharma," would be powerless. vytorin (or whatever else) tears up the market precisely because americans have a never ending demand to relieve their pain, to make their fat go away, to be beautiful, to be young, and to live forever. similarly, we are all going to die... very many of us by some form of cancer. that is part and parcel of life.

      November 18, 2011 at 23:14 | Report abuse |
    • liam

      Maybe this will begin a shift where the FDA is more than a yes man for big pharm companies....I won't hold my breath.

      November 19, 2011 at 05:03 | Report abuse |
    • crows feet

      i bet if women injected this stuff into their crows feet and made them disappear this thing would have kept approval and people all over Hollywood would be throwing self injection parties...

      November 19, 2011 at 07:03 | Report abuse |
    • scherr

      Correction. The adverse side effect were worse than the benefits. There were benefits, it was just more likely to kill you than help you.

      November 19, 2011 at 08:03 | Report abuse |
    • Andi

      @vman2003-First of all, all drugs on the market should not be determined for EVERYONE based only on what desperately sick people decide. Sick people should not be the ones making the ultimiate decisions for anyone but themselves. And secondly, if you'd read the article, THE DRUG WILL STILL BE AVAILABLE. The decision whether or not to take it will be up to the doctor and their patient.

      November 19, 2011 at 10:47 | Report abuse |
    • Christine

      vman2003 – If a medication kills you because no one controls it before hand, don't you think it will be a little too late to decide after seeing how it works with your body?
      It would be great if every patient could know everything to be known about a molecule before taking it but that would mean reading and understanding hundreds of scientific publications and patents. Most people don't have the time or knoweledge to do that, this is why we rely on experts. And yes, experts van also make mistakes and be wrong sometimes. But they will save your live most of the time.

      November 19, 2011 at 13:19 | Report abuse |
  2. Rocky Mac

    "Although the drug has been deemed “unsafe,” many women on Avastin swear by it and say it has made a difference in their lives." I would like to read the comments from the women who have been using this drug.

    November 18, 2011 at 17:29 | Report abuse | Reply
    • Rob

      If a woman with breast cancer drinks milk and feels better for a while she will swear that the milk impeded the cancer. The studies are clear and unequivocal that women taking the drug had no better results than those with the same extent of cancer who did not take it. This is how we determine the effectiveness of drugs, and avastin failed miserably. We should not be promoting false hope with expensive drugs that merely enrich the drug companies at taxpayer expense. Those who want to reduce healthcare expenditures by avoiding unnecessary treatments should cheer this decision.

      November 18, 2011 at 17:38 | Report abuse |
    • Michael

      Rob, I'm assuming that you have read the reports and watched the public ODACs that discussed the drug, it's uses, the studies, and their results? Hmmm... I'm a bit skeptical. This was absolutely not a slam-dunk. The FDA came to a tentative decision, but decided to go over it all again to make sure they were making the right choice. Doesn't sound like unequivocal to me. Then again, I'm sure you are an oncologist and have read the data and made the decision for yourself.

      On the bright side, Genentech is continuing to look at biomarkers to specifically identify women that may benefit. As Herceptin only helps patients that are HER2+, Avastin may only help a small subset of breast cancer patients.

      November 18, 2011 at 18:22 | Report abuse |
    • Adam

      I blame Avastin for the death of my mom. She died last year not from her stage 4 breast cancer, but from lack of oxygen to the brain from this medication which caused irreversable brain damage. She had to live the remaining months of her life as an unresponsive vegetable. My personal opinion: Avastin can cause more problems than solutions, take my story as an example...

      November 18, 2011 at 18:49 | Report abuse |
    • Mandy

      I'm using avastin right now for treatment of recurrent ovarian cancer and honestly, of all the drugs I've taken this has been the easiest to handle. I've occasionally gotten a bloody nose that I attribute to avastin. This cancer WILL kill me if it keeps growing, so I'll take the risks. Not yet approved for treatment of ovarian cancer, so my insurance wouldn't cover it, but Genetech is giving it to me for free. Trials have shown some good things with ovarian cancer and avastin. I hope the studies can continue.

      November 18, 2011 at 19:17 | Report abuse |
    • Doc

      Actually, if you read the studies, the drug was found to improve cancer-free survival but not overall survival. Thus, a patient's overall life expectancy was not made better by using Avastin, but the portion of that time spent with the cancer in remission was greater. That was what made this such a tough call – is there a tangible benefit to having a better quality of life, even if the life itself isn't extended by any meaningful length of time? A lot of people with cancer would argue that having a few extra months cancer-free to spend with family and friends, etc, instead of in-and-out of the hospital for treatment and disease effects, is totally worth it even if their overall life span isn't any better.

      But the cost of Avastin, plus the potential side effects (which Avastin has plenty of), ultimately outweighted that bit of benefit in the eyes of the regulators. It's a situation where really either decision was supportable, putting both the FDA and GNE in very tough positions. Avastin's a good drug that can do wonders with the right cancers (the brain cancer results were off the charts) – don't be surprised if they find a sub-population where Avastin works with breast. After all, this is the company that brought you Herceptin (a drug targeted to a sub-population of breast cancer patients).

      November 18, 2011 at 22:14 | Report abuse |
    • Jeff

      Adam – I am truly very sorry about your Mom. I am lucky to be on the other side of the Avastin spectrum – my Mom is alive today because of it. It has worked wonders for her, with no side effects. Hopefully Genentech will develop a method to better identify those who will respond well to the drug. Best wishes for you and your family.

      November 18, 2011 at 22:15 | Report abuse |
    • Bob

      Mandy: Did it ever occur to you that it is the "easiest to handle" because it is not really doing anything. Steve Jobs felt great on his alternative treatments of vegetable juices- up until the cancer got out of control. Had he taken a more aggressive treatment (chemo and radiation) he might have survived even if both treatments would have made him feel temporarily sicker than without the treatments.

      November 18, 2011 at 22:38 | Report abuse |
    • A-Cambridge

      (My last try at posting this seemed to fail) Avastin and other anti-angiogenic drugs work by blocking the VEGF pathway. Avastin is a strong antibody block of VEGF-A (unlike other drugs that block VEGF-A&B&C such as Sutent, Nexavar, and other drugs in late stage clinical trials as we speak). Part of the reason why Avastin has "relatively" low side effects is because of this limited inhibition. The good news is for some cancers blocking only the VEGF-A pathway works well. Unfortunately, for many others the cancer will simply use the bodies redundancy and channel signaling through the other pathways to continue growing. Also, I would like people to know that drug companies do years worth of clinical studies, but often these studies are a few hundred people. Humans carry a genetically diverse background and while drug companies try hard to model hundreds of clinical trial patients into 7 billion potential patients, it is naive to think it is possible to predict every positive event, or every potential negative event. All modern countries have similar methods to get new drugs approved and keep drugs that are unsafe off the market. However, while I find our system in the US to be very good, no system is perfect, but please share a better system before you complain of what already exists.

      November 19, 2011 at 08:32 | Report abuse |
    • Edwin

      Cambridge - you make a valid point. The medicine industry has potential for fraud and corruption, which definitely make news headlines. And they ARE motivated very heavily by profit margins, perhaps much more so than by the desire to make better medicines. But they also work in an industry that is massively expensive - it is staggering to imagine the sheer amount of money involved in research and development, not to mention the approval process and manufacturing design.

      If anyone has a practical suggestion how to improve the process, be sure to let the rest of us know! I, for one, am grateful the industry exists, flaws and all. I take more than one medicine on a regular basis, and I am alive because of it.

      November 19, 2011 at 10:23 | Report abuse |
  3. A. Nony

    ".....and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin" is the key phrase. Undoubtedly a (probably small) subset of the women taking Avastin benefit greatly from it, but the subset is not large enough to show up in the statistics of the overall population studied. It is becoming clearer and clearer that one's response to a given drug depends at least in part on one's specific genetic makeup and/or, in the case of cancer, on the exact genetics of one's tumor. In several decades, we will look back on this era of medicine as still in the Dark Ages.

    November 18, 2011 at 17:31 | Report abuse | Reply
  4. Rob

    It was a drug company sponsored study, but fortunately for the American public the researchers insisted on complete autonomy because of the sad experiences others have had with such studies. We have learned a lesson about the perfidy of drug companies. From a scientific perspective, the FDA made the right call on this. Patients need to be protected rather than sacrificed on the alter of corporate profits.

    November 18, 2011 at 17:31 | Report abuse | Reply
    • Nah

      rob: "From a scientific perspective, the FDA made the right call on this. Patients need to be protected rather than sacrificed on the alter of corporate profits."

      *yawn* Try harder when you troll.

      Or wait, are you really this dense?

      If profit is the motivation for a drug company, then it stands to reason that they'll have to make a product that, you know, works so people will, you know, buy it.

      So long as the FDA is making sure the medications are generally safe, the profit motive gives a substantial reason for investors and businesses to develop cancer beating drugs.

      November 18, 2011 at 18:23 | Report abuse |
    • oldboldgold

      I don't know about usefulness. Oxycontin is very dangerous and doesn't work any better than aspirin.

      November 18, 2011 at 22:26 | Report abuse |
    • Edwin

      oldbold: yes it does, but not for all kinds of pain. It is for specific kinds of problems.

      November 19, 2011 at 10:26 | Report abuse |
  5. kev

    Until the FDA better regulates things that cause cancer...we cannot trust them to approve things that cure cancer. But then drug co. would lose BILLIONS. My heart truly goes out to the victims of cancer, i wish the best for you!!!

    November 18, 2011 at 17:34 | Report abuse | Reply
    • Chris R

      Look, people were getting cancer *long* before this. Thousands upon millions of years ago animals and our evolutionary ancestors were suffering from cancer. If you live long enough *you* *will* *get* *cancer*. That is what a lot of people don't understand. Cancer seems to be a nearly unavoidable consequence of mammalian evolution. There are chemicals and substances that will cause cancer but the most powerful and effective FDA in the world wouldn't be able to *stop* cancer. Reduce the occurrence of certain kinds? Yes, without a doubt. But people would still be dying of it. So they need to be involved in the process of vetting cancer medications.

      November 18, 2011 at 19:10 | Report abuse |
  6. kev

    i meant *because then.

    November 18, 2011 at 17:35 | Report abuse | Reply
  7. Tom

    I really believe it is more profitible to treat cancer than cure it, from what I have een working in the medical field for many years

    November 18, 2011 at 18:02 | Report abuse | Reply
  8. yuri pelham

    Big pharma takes advantage of desperately ill people incahoots with oncologists who offer chemo (big bucks) when they should be offering comort. There's a lot of false hope and needless suffering going on. Sorry Avastin is useless, glad it was exposed. A dangerous and expensive placebo.

    November 18, 2011 at 18:11 | Report abuse | Reply
  9. Sue

    "As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be..." ARE YOU KIDDING ME?!?!? You have NO idea how frightening until you have walked in our shoes, literally! HOW DARE YOU MAKE SUCH AN ARROGANT STATEMENT as you pull the rug right out from under those women who feel that the drug is working for them and who do not suffer the side effects...how do you sleep at night?!? Really, as if you know what it means to have your life hanging by a thread. I am a metastatic BC THRIVER and if Avastin were the drug that I felt was doing me good (inspite of the research data stating otherwise), I would be devastated...let these people take the risk!!! The disease is incurable, so why the heck would you remove a drug that is working for some...people are not statistics...every individual responds differently than the next person. I love the way the clinical side of this lumps everyone into a statistic and because the "data" doesn't prove something it MUST not be working...I say BS to that. I would give the patients the option of taking the risks...explain to them the dangers and let THEM decide...so now you are going to not give it to them so the free fall and die anyway? This is tragic...and without insurance these drugs are way too expensive for most people to purchase on their own...this is unbelievable. The drug I am on costs $3000 for a 8 week supply if it wasn't covered...I can only imagine how much Avastin costs...shame on all of you...

    November 18, 2011 at 18:12 | Report abuse | Reply
    • nutmegri

      I believe it is near $8000/month. I love your post Sue! Amen!

      November 18, 2011 at 19:07 | Report abuse |
    • Tom

      You are a Doctor who says cancer is incurable. Yes, by your definition. This is one reason I would never let any of my friends or family members step in the door of your clinic. Thus, because I would be arrested because of the big money people in the cancer industry I cannot say cancer is curable. I have to tell people that I found the cure for the body to heal itself of cancer.
      Folk, go get a copy of Dr. Robert Young's book, The pH Miracle... The truth set me free...

      November 18, 2011 at 23:46 | Report abuse |
  10. Fred

    Shameful. Another example of the .gov taking care of us.

    November 18, 2011 at 18:30 | Report abuse | Reply
    • marty rogers

      so you would be okay allowing free range for pharma to sell drugs to desperate people that cost a fortune, have no benefits, and are toxic with nobody examining the data before they are released?

      November 18, 2011 at 18:52 | Report abuse |
    • Fred

      I'd allow a proven drug to continue to be sold, sure.

      November 19, 2011 at 14:48 | Report abuse |
  11. glioblastomarunner

    Absolutely OUTRAGEOUS!
    My wife has glioblastoma. She also suffered from radiation necrosis from the radiation treatment.
    the radiation necrosis totally destroyed my wife both in movement and in cognitive abilities.
    UPON THE FIRST INFUSION of avastin (prescribed to her by the great doctors of MD Anderson, my wife could walk again and gained back her ambulatory abilities.
    She never got back her cognitive abilites, but I SAW THE WONDERFUL AFFECTS OF AVASTIN..
    My wife would have been dead or WORSE in a nursing home right now had it not been for AVASTIN!

    November 18, 2011 at 18:31 | Report abuse | Reply
    • marty rogers

      the denial is for breast cancer not brain cancer. It may work for your wife's type of cancer but not for others.

      November 18, 2011 at 18:56 | Report abuse |
  12. NoobozaurusRex

    This article brings about a moot point. The FDA considers, and has considered, a wide range of Chemotherapies to be deemed "safe and effective" and yet all exhibit a side effect known as "toxic death". Conventional therapies in the United States of America are limited to Surgery, Chemotherapy, and Radiation. People are going to their oncologists upon discovery or diagnosis of cancer and do not realize the other options that are available with NO risk, yet deemed against the law or not yet proven effective through a double-blind case study. Please educate yourselves everyone, it may just save your's or your family's life. Cancer therapy has not changed in the past 80 years and the survival rate of 5 years (of which by definition for "cure" of cancer means "still breathing after 5 years from diagnosis") has not changed at all either. The time for the awakening is now.

    November 18, 2011 at 18:37 | Report abuse | Reply
  13. marty rogers

    avastin is a very strong drug with very harsh side effects. I cannot imagine it improving anybody's quality of life. as to improving how long they live, not sure, may be cancer type specific.

    November 18, 2011 at 18:43 | Report abuse | Reply
  14. bill

    or it means the government makes more money off of people being sick then they would if they were to get better

    November 18, 2011 at 18:53 | Report abuse | Reply
  15. Jimh77

    The way I see it, they shold have done a Phase 3 study before they went for FDA approval to release the drug for use. People have all types of chemistry and not all bodies can take the drug w/o complications, those that can get a great drug. Just that alone there is no reason to BAN the drug, just find out who can not use it, and cure those that it works for. This should be the same with all drugs. Instead, drugs are pushed into the market place and the Dr's are the ones that have to monitor their patients. Not enough R&D before releasing into the population. Oh the almighty Dollar.....

    November 18, 2011 at 18:54 | Report abuse | Reply
    • Ken

      Avastin received accelerated approval that is subjected to delayed phase 3 and phase 4 testing. This is how something that looks initially promising is rushed into widespread availability. Sometimes they work (that's how imatinib was rushed to treat CML patients) and many times they don't.

      It's a balance. You have to rigorously test but sometimes things hold so much promise that you allow them to get temporary approval before everything is known (which can take years). Yes, it's a process that can be influenced by money and politics, but what possible alternative would one consider? A totally unregulated pharmaceutical market?

      November 18, 2011 at 22:23 | Report abuse |
    • yuri pelham

      Everyone gets rich off the body of a dying patient. They have status because they are wealthy. I see them as maggots.

      November 19, 2011 at 00:16 | Report abuse |
  16. scott

    I wonder how this affects it's use in the treatment of diabetic eye disease?

    November 18, 2011 at 18:57 | Report abuse | Reply
  17. Shelby

    "Although the drug has been deemed “unsafe,” many women on Avastin swear by it."

    Great idea. Abandon scientific study. Ignore statistics. From this point forward, we will rely on the emotionally charged gut feelings. It's not the FDA's job to appease wishful thinking.

    November 18, 2011 at 19:07 | Report abuse | Reply
    • Carl

      You make the assumption that their statement is based on emotion. The statement was open ended. Perhaps it actually HAS physically helped these women who now must search for another drug because they will likely not be able to afford this medication or it just won't be made any longer.

      November 18, 2011 at 19:58 | Report abuse |
    • Shelby

      "Perhaps it actually HAS physically helped these women."

      Again, the FDA requires evidence. It HAS NOT physically helped some women. The women who wasted their precious time on earth placing trust in this drug are not here to tell us how worthless it was. Anecdotal evidence has corrupted medical beliefs for most of human existence. We now know that it is the wrong approach to draw conclusions from individual cases. Your understandable empathy with sick women is understandable, but ultimately destructive. You must resist the temptation to pick the feel good position and let the research provide the answers. Otherwise, we would still be treating a modern polio epidemic with snake oil.

      November 18, 2011 at 21:50 | Report abuse |
    • Doc

      Shelby, you're wrong. It has helped some women – see my comment above. The argument was the value of increased overall survival (which the FDA required) vs. increased disease-free survival (which Avastin provided). If you're living 12 months either way, but you have the choice of living 10 of those months cancer-free vs. 3 months, that's something a lot of cancer patients would take in a heartbeat. Unfortunately (for those patients), if that's all the drug can deliver, then it has to have a very good risk/benefit profile both in terms of potential side effects and in terms of cost. Avastin was simply too expensive and too risky (though its side effect profile is really not that different from most chemotherapeutic agents) to let it on the market solely as a means for improving tumor-free survival.

      But that doesn't mean that the drug showed no benefit, or that women who took it didn't get any benefit. The benefit simply wasn't great enough.

      November 18, 2011 at 22:21 | Report abuse |
    • Sue

      You apparently have near had to deal with a deadly disease personally...no one is saying disregard scientific study...we are saying that people are not statistics and that it is working for some women. Why take it away from them. I think this black and white approach is ridiculous. For those it doesn't work for and who suffer horrible side effects, change their drug. For those who are managing it well and living a better quality of life REGARDLESS of length of survival, let them keep taking it. I guess we should make alcohol illegal because not everyone can handle their drink...it does cause alcoholism in many...oh, that's right, insurance isn't involved...yes people, this is another decision based on money....

      Try walking in our Metastatic shoes and have what you feel is saving your life (irregardless if its true or not because YOU DON"T REALLY KNOW THAT), ripped from your hands...or better yet, how about you tell their children that Mommy can no longer have the drug that is helping her and instead of living 5 more years, she's looking at maybe 2. She was going to die anyway so why bother giving her a drug that makes her feel better...

      November 19, 2011 at 08:47 | Report abuse |
  18. Not big Pharma

    Most of you obviously have no clue what it takes to get a drug on to the market. So sick and tired of hearing how BIG Pharma is trying to steal your money away. Yes, I work for BIG Pharma... I see each day what we have to go through to try and get some drug approved. BIG Pharma does not just want to sell you something, WE ACTUALLY want to cure you. People who dedicate themselves to develop these treatments do not do it for the money, but because WE care.

    So... all of you who think BIG Pharma is just after your money... go eat grass.. wood... or some wack root ... no one is forcing you to take BIG Pharma medicine...

    November 18, 2011 at 19:09 | Report abuse | Reply
    • Meg

      Hear, hear!

      November 19, 2011 at 10:48 | Report abuse |
  19. southern_gent_from_mississippi

    Relying on anything the patients have to say about it is sheer lunacy anyways. A few 'praise th lords' on sunday makes them feel better also and tests prove that sugar pills help, too, as long as they believe its real medicine. Why dont we all just travel back to the middle ages and everything will be fine and dandy as long as we 'feel ok' and drop dead the next day from ineffective treatments.

    November 18, 2011 at 19:10 | Report abuse | Reply
  20. Steve Lyons

    It sure would be nice to see 60 minutes "out" all the members of Congress that placed stock trades last month leading up to this announcement.

    November 18, 2011 at 19:20 | Report abuse | Reply
  21. Merecat

    Just get some Essiac.. 4-Herb Tea... it WORKS... and is good for diabetes and lots of other good things... It's not toxic and can be taken w/any other medication including chemo and radiation.. Youtube... Rene' Caisse and watch her videos.. the Cancer world doesn't like it.. because they stand to lose lots of money.

    November 18, 2011 at 19:25 | Report abuse | Reply
  22. glioblastomarunner

    In terms of side effects, I can only speak of a study of 1 and many more victims of all kinds of cancer that I speak to, RADIATION is much more toxic and hazardous than avastin.
    If radiation is considered OK in the standard protocol for cancer, I sure can't see a reason why avastin can't be also.
    The only side effect so far for my wife with avastin is minor bleeding, infections that won't heal and bruising in the breasts.
    Radiation on the other hand left her with a condition MUCH worse than the cancer....
    I do realize we are talking about different forms of cancer but all of the treatments seem to cause side effects.....

    November 18, 2011 at 20:32 | Report abuse | Reply
    • Ken

      Yes, many treatments have dangerous side effects. We should only use treatments whose benefits outweigh the harm. Ideally this would be determined at the individual level for everyone but that's not feasible. So researchers have to make decisions based upon population studies – and if the treatment is deemed beneficial to more people than the harm then it has a good chance of being approved.

      Radiation can be dangerous but can also melt tumors away. That's why it's used in many types of cancer treatments and for bone marrow transplantation.

      November 18, 2011 at 22:38 | Report abuse |
  23. dudeGuy

    This is an issue of the accelerated approval process. The FDA will grant companies the ability to market a drug based on promising but inconclusive data. In this case, the promising data was that Avastin shrinks tumors. So, the FDA gave Genentech an accelerated approval of Avastin with the stipulation that later on (now we know the results) would show that Avastin would decrease the death rates of subjects that took the drugs. The problem is that measuring tumor response does not take as long as measuring death rates. So, in studying cancer drugs we will learn that a drug will reduce tumor sizes before we learn about death rates. So, if you were in the FDA and someone told you that drug X shrinks tumors, would you grant the drug company a license to market the drug… even if later data you might find that the drug does not help survival? I think I would. Would you? This is an interesting ethical quandary. Google “accelerated approval”.

    November 18, 2011 at 21:23 | Report abuse | Reply
  24. Marc

    Avastin has been a miracle drug for my eyes. My retina specialist said that 3 yrs ago there was no treatment for what I have. Luckily a researcher from John Hopkins found that people receiving the drug for cancer saw improvement in their eyesight. Genentech developed a similar drug for eyes and it was FDA approved however test between the two the patients saw no difference except in their wallet. $450 for one tiny dose of Avastin vs over $2000 for the other one was a no brainer. If others using it for breast cancer and now can't I feel for you. Why the FDA does this is beyond me. It should be left up to the patient to decide what their choices are. People get illegal steriods with no problem and people who need and want this drug can't get it.

    November 18, 2011 at 21:27 | Report abuse | Reply
  25. somehow

    The FDA is owned by the drug companies, proven fact.

    November 18, 2011 at 21:39 | Report abuse | Reply
    • oldboldgold

      Not "owned" so much as "the same." They share employees through a revolving door that creates serious conflicts of interest.

      November 18, 2011 at 22:28 | Report abuse |
  26. ldtsb

    its very sad that many people have taken this medication with the hopes of getting better and may have ended up dying because of it. doctors/pharmaceutical companies and the government need to really start looking out for the true health and welfare of people/taxpayers instead of treating and curing its simply a business with no compassion or care. just the bottom line. and thats a very sad state of affairs.
    how was this medication approved to begin with if it was later proven to be a negative? these people know better

    November 18, 2011 at 22:11 | Report abuse | Reply
    • ldtsb

      might i add these people put their trust in the hands of the same doctors and governments and still died in vain

      November 18, 2011 at 22:16 | Report abuse |
    • dudeGuy

      See my answer above.

      November 18, 2011 at 23:28 | Report abuse |
  27. PhilG.

    Soon to be overturned by a paid for politician in Washington so the drug can be sold again even though it's dangerous and it does not work.

    November 18, 2011 at 22:37 | Report abuse | Reply
  28. jsrocklock

    Why is it that when evidence based medicine rules out a drug, everyone celebrates, but when they alter mammography screening recommendations for the SAME reasons, its a tragedy lined with anecdotal support?

    November 18, 2011 at 22:46 | Report abuse | Reply
    • marty Rogers

      because mammograms have extremely low side effects and when it does find something, it till likely be early enough to save somebody's life. the argument against early screening was bogus: it was based in the very low number of women who have breast cancer before 50 and the cost of the test. That is important but not as important as saving that small group of women unfortunate enough to develop breast cancer before the age of 50. If you remove cost, the risk to benefit ratio it is very favorable!

      November 18, 2011 at 23:14 | Report abuse |
    • jsrocklock

      That's exactly what I meant, thank you for being my showcase. It isn't the radiation dose from a mammogram, it's the women who undergo surgery and other treatments from ambiguous results that may have never needed treatment (and yes, some of these women die from their unnecessary treatment). Saying cost played into that decision is crazy.

      November 18, 2011 at 23:31 | Report abuse |
    • marty rogers

      oh please, most women with a positive mammogram simply go back for a second and it gets ruled out. If not ruled out, then they have a sonogram, which has zero risks. Only a tiny % of these undergo a biopsy, and I have never heard, at least in the US, of anybody losing their life from a biopsy. I have, however, heard of women of dying of cancer that was caught too late. no contest.

      November 19, 2011 at 00:23 | Report abuse |
  29. eman


    November 18, 2011 at 23:12 | Report abuse | Reply
  30. eman

    Sad. .

    November 18, 2011 at 23:15 | Report abuse | Reply
  31. Ohreally

    Let me know when the FDA gets rid of the unneeded highly addictive painkillers that are destroying the nation.

    November 18, 2011 at 23:16 | Report abuse | Reply
  32. Roberto

    Pharm companies have really gone way beyond with drug development. The enormous amount of money poured into their research way exceeds that which is spent on the government side. If the NIH could concentrate their efforts into drug development on the scale of private companies, along with some government oversight, maybe we'd make some progress and not come up with these drugs that hit the market and, three years later, get yanked because they are found to be more detrimental than curative. And what about those drug names? Bulabyacinovgitaviv and Rubaduvihobitov. Who are these things named after?

    November 18, 2011 at 23:27 | Report abuse | Reply
    • scientist

      Avastin is still approved for other cancers and by the way drugs are usually named for chemical or biological active ingredients, etc. For example, drugs that end in -mab are Monoclonal AntiBodies...a biopharmaceutcial...get it?

      November 19, 2011 at 23:01 | Report abuse |
  33. Derrasaurus

    Avastin may help in the treatment of neurofibromatosis, which I have. After I had one brain tumor removed surgically, I have hope Avastin therapy will shrink the other one. Unfortunately breast cancer patients no longer have this hope...and I'm sorry for that. Keep fighting.

    November 18, 2011 at 23:36 | Report abuse | Reply
  34. Chedar

    This drug has been effective in brain cancer. It is unfortunate it did not work on breast cancer

    November 19, 2011 at 00:11 | Report abuse | Reply
  35. BC survivor

    I’m a BC survivor and so far didn’t have a recurrence; I work every day talking with other survivors of this disease, my humble opinion is that instead of pulling the plug on Avastin the FDA should require all doctors recommending this medication to take the time to explain in detail the pros and cons to patients that way they can make an informed decision about this particular drug, and give more time to Genentech to come out with a better way to predict which patients can benefit the most with the drug. It’s just radical and inhumane to rejects the drug at once, leaving thousands without ways to continue with their treatments

    The real issue here is BC patients are caught in the middle of this back and forth and the FDA is giving one more reason to the many reasons insurances companies already have to deny coverage for cancer treatments. As someone who knows the risk of a BC recurrence is always there I don’t want anyone including the FDA, the Insurances companies, the Pharmaceutical companies or the doctors to make a decision for me, what I want and expect is for all of them to give me the information and tools to make the decision that I consider could be appropriate for me. Of course there are lots of emotions involve in the decision making process for a cancer patient but if we are given the right information we are capable of making informed decisions about how we want to live and be treated when we have a serious illness like breast cancer.

    November 19, 2011 at 00:15 | Report abuse | Reply
  36. Generik

    If only there was more than 1 month dedicated to breast cancer awareness we may see some effective treatments developed.

    November 19, 2011 at 00:20 | Report abuse | Reply
  37. yuri pelham

    google " chemobrain"

    November 19, 2011 at 00:31 | Report abuse | Reply
  38. GInny

    How sad to give hope and then take it away. There needs to be control over pricing costs also since the insurane won't pay anymore.

    November 19, 2011 at 00:39 | Report abuse | Reply
  39. Bert Bigdongle

    There must be a racial angle to this story for CNN to probe... Somebody, somewhere, insulted a black person as part of this.

    November 19, 2011 at 01:53 | Report abuse | Reply
  40. Lost

    The fight against cancer is a lifetime and environmental battle.

    November 19, 2011 at 02:40 | Report abuse | Reply
  41. Keith

    Since when did the FDA become concerned about side effects??? My wife is suffering from side effects of Cipro that are irreversible and the FDA has known about them for years but has chosen to look the other way. The doctors know about them too but since their pockets are being padded by the drug companies, they just keep prescribing them like candy. If the drug is effective for curing breast cancer, then they should approve it and list the known side effects and let the patient decide if it's worth the risk. If they had been honest about the Cipro side effects, at least my wife would have been able to decide if she wanted to take a chance. Since they lied about them, she's having to live with the damage it's done.

    November 19, 2011 at 03:33 | Report abuse | Reply
  42. SandiB

    Having worked in the medical field 4 over 25 yrs., I have seen and heard things that would scare people unnecessarily! However, having 2 literally fight 4 my own life since about age 17, and now having been FORCED yrs ago on Long-Term Disability, even after telling my Primary Care doc that I had been dealing witht these issues 4 yrs, knowing I would get worse if I were not allowed 2 continue working, I was overridden and put on LTD. The bottom line today, thanks 2 big money-the pharm industry-I am just home from a hospital, stil with multiple blood clots in my lungs and leg, unable 2 stay on my feet more than a few mins at a time, the overwhelming pain is 2 much, I have lost my home, my secondary ins I had paid 4 over 22 yrs because of a stupid ruling my employer made changing my monthly premium from 51.00 a mo to 274.00 a month, and me trying 2 live on 1300.00 mo, alsn losing EVERYTHING I had worked 4 my entire life, but when my coverage 4 the many meds I have 2 take, I found that the pharm companies had jacked prices for most of those meds when you are self-pay to as much as 600 percent because no other companies other than the initial patent holder have stopped making generics, so the ORIGINAL patent holder holds all the cards, so they just see dollar signs. However, working with all types of cancer victims, I see and have lost many friends to this insidious disease, I feel that there will NEVER be a true cure or possibly effective treatment 4 cancer 4 ONE REASON! Too much money to be made by keeping these ilnesses around! Myself, being an extremely diffult diagnostic problem always, have spent as maoy as 6 mos in a hospital, watching myself daily die, but obviously God still has plans 4 me, as contrary 2 what the so-called medical professionals have told me over the many yrs, I am stll here! My heart goes out 2 ALL cancer victims, plus those like myself, but hopefully some day soon, someone will realize why they are getting no real help from many drugs thrown on the market entirely 2 soon!

    November 19, 2011 at 03:58 | Report abuse | Reply
  43. Steve

    The FDA does work. Contrary to what the internet trolls say.

    November 19, 2011 at 04:06 | Report abuse | Reply
    • anthony quatroni

      Yes, and you work for them, don't you?

      November 19, 2011 at 09:06 | Report abuse |
  44. rs1201

    Anyone who thinks that there are conspiracies between the pharmaceutical industry and the FDA doesn't know what they're talking about. Firstly, no candidate drug is submitted to the FDA without thorough testing and retesting and some more retesting. It takes close to 20 years from the inception of the idea of a drug to the FDA submission. Why do you think it takes that long? it's the incessant testing and screening that's done to make sure that the drug in question does exactly what it's supposed to do and not more. Side effects are watched very carefully and they could and do usually cause the demise of a drug. Only a couple of drugs out of hundreds if not thousands make it to the FDA...that's thousands of hours of research, millions of dollars spent on materials and scientists, animal testing and finally clinical testing on humans. A drug usually will fail in Phase II clinical trials that's after an enormous amount of effort, money, and resources have been dedicated to that drug. That is one of the reasons that drugs are expensive. The pharmaceutical industry has to recoup all these costs from somewhere...it is not a non profit effort ...it is definitely a for profit endeavor...so before you conclude nonsense about than industry, read and do some research...you'll find out enough to admire all the brilliant scientists that spend long hours in the lab and at home thinking about new drugs and how to bring them to the point of FDA submission.

    November 19, 2011 at 06:16 | Report abuse | Reply
    • anthony quatroni

      Must be nice to live in a perfect world. Too bad no one else lives there but you.

      November 19, 2011 at 09:08 | Report abuse |
  45. Willa45

    The side effects are sobering if not downright frightening....I'm just wondering why it was banned for one type of illness but OK to prescribe for others?

    November 19, 2011 at 07:17 | Report abuse | Reply
    • A-Cambridge

      Not all patients get all side effects. Drug companies are required by law to report a y adverse effect that might be attributed to a drug the patient was on. Relatively speaking (and yes cemo drugs are nasty on the body), Avastin is well tolerated. This issue here is specific to metastatic breast cancer, is there enough medical benefit to warrant its use?

      November 19, 2011 at 07:58 | Report abuse |
  46. nomammo

    Pull the plug on ALL funding for women's health issues. There are too many (women) in the world today and no one will miss what nature has selected to go.

    November 19, 2011 at 07:24 | Report abuse | Reply
  47. CommonSense

    Yet cigarettes are still approved by the FDA.

    November 19, 2011 at 07:54 | Report abuse | Reply
    • Matt

      Very true. Just ask all the people in Canada who's parents too thalidomide while pregnant. That was never approved in the US. The only Americans who took it went to Canada to get it.

      The bottom line is that no drug is 100% safe, especially when being taken by a large, genetically diverse population. And that especially applies to cancer drugs. It is VERY difficult to make a drug that selectively kills cancer cell. Cancer cells are you own cells. Even your own body can't tell the difference between cancerous cell and healthy cells. Basically, it is slightly easier to kill rapidly dividing cells than non-dividing cells. That's why the difference between "poison" and "cancer drug" isn't always obvious.

      November 19, 2011 at 08:42 | Report abuse |
    • Edwin

      Is that really true? I thought tobacco was regulated via the ATF (Alcohol, Tobacco, Firearms) agency. FDA only handles Food and Drugs, and tobacco is not actually considered either officially.

      November 19, 2011 at 10:49 | Report abuse |
    • CommonSense

      Yes, cigarrettes are under the FDA since around 2009.

      November 19, 2011 at 11:06 | Report abuse |
  48. alan

    This just goes to show how under-tested drugs are before they go to market. How many other dangerous drugs are we taking that may kill us in the long-term?

    November 19, 2011 at 07:54 | Report abuse | Reply
    • Edwin

      My brother died from the side effects of a heart medicine. It was prescribed because his blood pressure was dangerously high; even though the medicine carried risks, the doctor thought it was a better choice to use the medicine than not. In hindsight, it was a poor choice, but doctors cannot see the future. There are risks to taking medicine, and risks to NOT taking medicine.

      BTW, ALL medicines can be "dangerous" as you put it. My wife nearly died from an sudden allergy to aspirin - in spite of years of safe use. Does that make aspirin dangerous? (Large scale trials of aspirin have shown people to die from it.)

      Drugs are dangerous. So is not taking drugs. The best we can do is to look at what is available and weigh all the risks.

      November 19, 2011 at 10:47 | Report abuse |
    • Sue

      The standard American diet for one thing...that is killing us long term....engineered, cheap food, devoid of all nutrients...EAT UP!

      November 19, 2011 at 11:37 | Report abuse |
  49. KAT

    Where's the "CURE"? They want you dead and will make a killing getting to that point.
    Stay far away from doctors. Don't believe me? Watch.

    November 19, 2011 at 08:55 | Report abuse | Reply
  50. government cheese

    It takes years for a drug to get approved by the FDA. This one was. Now, they are saying the drug doesn't work, because it is expensive? The rationing begins...

    November 19, 2011 at 10:41 | Report abuse | Reply
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.