Has American Bedu Lost Her Lifeline?

A mere six weeks ago I was told I could have a break from chemotherapy.  Finally, after six solid months of chemotherapy, I could look forward to a “nearly normal” life again!!  However, I must continue bi-weekly treatments of the drug, Avastin, which has been pivotal in keeping my cancer at bay.  This news was among the best I’d received.

But last week the bubble burst.  Due to the FDA decision to revoke its approval of the drug, Avastin, it is now no longer available to me and many other women.  Avastin was revoked because the FDA states that the side effects are more harmful than benefits.  The FDA further stated that Avastin did not prolong lives long enough to warrant the high costs.

The possible side effects of Avastin such as high blood pressure, bloody nose and a few others are well-known by the physicians.  Patients are monitored closely.  I had been receiving Avastin for the better part of a year.  I know other women who have been on Avastin much longer.  A doctor subscribes Avastin for a patient because it works.  Avastin does stop the cancer cells from spreading and growing.

What is the real reason the FDA revoked its approval?  It’s not politically correct for the FDA to say so, but I will.  MONEY.  Avastin is not cheap.  It costs US$88,000 per year for a woman to receive.

Although the FDA revoked its approval, a woman may still receive Avastin…if she can self pay.  That rules me and many other women out.

For women like me, who are HER2 negative, there are few choices of drugs which can be effective.  Avastin is the one that has worked.

It’s a shame that it is becoming more difficult for doctor’s to administer to their patients.  The government should not be involved or make decisions about health care.

Women outside of the United States can still receive Avastin.  Many doctors practicing in European countries, Canada and Saudi Arabia continue to administer Avastin to Stage IV breast cancer patients.  In many of these countries with a Nationalized health care system, there is no concern on behalf of the woman for payment.  The cost of Avastin is absorbed by the government.  Yet, Avastin, a drug manufactured by a US pharmaceutical company, is no longer available to the American woman.

Of course my doctor is aware of the FDA’s decision.  I see him next week and will hear what new plan of action he has for me.  I hope that I do not have to return to the heavy duty chemotherapy where the side effects can be very debilitating.  Stay tuned.

 

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48 Responses

  1. I am so sorry to hear this, I thought women who were on the drug could keep taking it 😦

  2. Thats so sickening to hear..i can imagine some women loosing more hope in their fight to live.
    I remember saying it when you first posted about this topic..its all a big business at the end of the day..and poor american women are not worth their money plain and simple.
    Inshallah you find a better solution.

  3. Dear Carol, I am so sorry to hear that. I hope you can get something to help you. I know how you feel I have been on Herceptin for years and I would be devastated if they took it off the market. Avastin also is used for advanced colon cancer. I hope there is a way you can continue with the drug.

  4. Let us hope this is one of those times where one door closes and a better door opens to your treatment. Whatever the outcome we are all pulling for you.

  5. The drug will remain on the market for treatment of other cancers, which means breast cancer patients can use it off-label.

    “If an individual patient sits down with their physician and goes over the risks and benefits and wants to continue, that is a decision that they can make,” said Hamburg.

    However, the FDA decision could free up insurers to deny coverage of the drug, which can cost up to $100,000 a year. In June, a spokesman for the Centers for Medicare and Medicaid said Medicare would continue to cover Avastin for breast cancer treatment even if the FDA withdrew its approval. — Carol I found this from Nov.18th. Dolores

  6. That just broke my heart man. I have been reading your blog for years, I think the world of you. It’s weird feeling so strongly about a virtual stranger, but you are worldly, you are smart, and you’re absolutely pleasant. I used to enjoy browsing through the comments while sipping on bourbon after a long day, because they’re just hilarious, and I could not help but take part recently.

    You have provided a great service through-out the years. Is it possible to rally an international petition for this drug? So Americans and non-Americans can have their say? I’m sure you’re not the only one that’s facing the consequences of the FDA’s decision. I am more than sure that the people who visit this blog, will offer their support; be it financial, or just trying our hardest to over rule their decision.

    Again, not to overstep my boundaries. You just have no clue how many lives you have touched, just by reaching out. I used to always feel at odds with myself, but reading your posts, and the comments, just always made me feel better. So please reach out to the community you’ve helped cultivate, so we can do something to change this situation.

    Hell, even we can’t change the decision here in the States. Let us kick start a fund so you can get treatment up north in Canada, or any country that would be easy for you to relocate and get the treatment you need.

    It truly was a downer reading this post.

  7. @Crantode – ‘ In June, a spokesman for the Centers for Medicare and Medicaid said Medicare would continue to cover Avastin for breast cancer treatment even if the FDA withdrew its approval’

    That sounds encouraging. I hope, for Carol’s sake it is still true.

    @Carol – ‘ The government should not be involved or make decisions about health care.’

    So you are for abolishing the FDA? I can’t imagine that to be true.

    Perhaps we can get some of those ‘Occupiers’ to sit on these drug companies’ stoops until they make these drugs reasonably affordable to people. Perhaps you could do an interview with someone from Genentech and we can get an answer from them about why this drug needs to cost that kind of money.

    We need to make sure that the outrage is properly directed.

  8. I’m a Medicaid recipient and it is one of the many carriers who has also decided to stop coverage of Avastin.

    I met with my oncologist yesterday. He is making some investigations to see if there is some way to continue Avastin but not very optimistic. Unfortunately other options through my oncologist are not available until my cancer were to spread and grow!

    It’s discouraging when Avastin has been sustaining my cancer.

    I think it is important to spread the word about this. For those who are US citizens, write your local Congressman/woman about this. I’ve no doubt I am but one in a large pool who are floundering now.

    While I thought about seeing if I could somehow get treatment outside of the US, I don’t want to be away from my family. They are my primary support network and motivation to keep fighting this disease.

    I thank everyone for their comments.

  9. Carol – Tal to your oncologist, The buzz from the cancer center here is that avastin is only removed when used in combination with paclitaxel.
    and that too when used instead of Chaemotheraphy..

    from what i now of your situation you are on alternate break theraphy with Chaemo and then the avastic for HER2 . I do beleive this is still at play.

    Don’t worry, don’t panic, I will email you with the docket info and all this should mean is the labelling info, yes i agree the insurance fellas will come down on this, BUT from whati hear we still cover it here as of yesterday eve.

  10. I shared this on Facebook. I hope your Dr can figure something out. I will pray for you. Hugs.

  11. I am very sorry to hear that you will be directly affected, Carol. However, your physician must know that there are other drugs that can be used in alternative therapies, including:

    Paclitaxel
    Docetaxel
    Trastuzumab
    Capecitabine
    Capecitabine + Docetaxel Abraxane
    Lapatinib
    Ixabepilone
    Eribulin mesylate
    Gemcitabine +

    The FDA’s reasoning for withdrawal is this:


    Women who take Avastin (bevacizumab) for metastatic breast cancer risk potentially life-threatening or serious side effects, such as bleeding and hemorrhaging; heart attack or heart failure; severe blood pressure; and the development of perforations in different parts of the body such as the nose, stomach and intestines.

     
    These are the considerable risks of taking Avastin and can be justified only if there is good evidence that the use of the drug will benefit the patient. For some kinds of cancers, Avastin has been shown, by rigorous scientific testing, to provide a benefit that justifies its risks.  After reviewing the available studies, however, it is clear that there is no proof of a benefit in breast cancer patients that would justify those risks. Avastin has not been shown to provide a benefit, in terms of delay in tumor growth, that would justify its risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life.

    The FDA’s Oncologic Drugs Advisory Committee participated in the June 2011 hearing and voted 6-0 in favor of withdrawal of approval of the breast cancer indication.”

    Withdrawal info and full transcript of the hearing can be reviewed here: http://google2.fda.gov/search?q=Avastin&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*

  12. I am sorry to hear that, Carole. I wish you the best in any decision you make and I hope you will beat this thing soon. Our prayers and wishes are with you.

  13. I understand the FDA docet, however i don’t agree with it’s analysis.. The FDA is a fine and dandy organization which wors great ( mostly) they have their own screwed up issues. but let’s not deviate.

    What this ruling is simply that they don’t have the numbers that they require ( for proof of stopping tumor growth) in breast cancer patients. well that’s the disease in a nut shell it behaves /morphs and presents different situations based on various factors .

    basically what this ruling amounts to is ” we don’t think the cost is justified” .. basically they are saying it is not worth paying so much money to extend a life the 3,4,5,yrs ….

    There is a big push from a lot of sources for this to have happened. this i sno different that a lot of crap that has come doen the line in terms of interfearence as to how to do our job. In my profession i’m under a microscope fromt he insurance guys pretty soon, so i know how to deal with that, but sometimes it makes me wonder how some people sleep at night…

  14. @Radhaa – Thank you for the info. It looks like I can receive 2 more doses of avastin before 01 January 2012 and then it is cut off. Avastin has been my sustaining grace between chemos. I know my doctor is still exploring options.

    It is difficult to acquire info on how many women have been relying on Avastin to get an idea of numbers. The HIPA laws make it difficult.

    The FDA trials in the early Fall were such a travesty. I say that because several of the individuals on the FDA panel were photographed sleeping while on duty! And this was while patients were giving testimony and doctors were providing facts.

    I agree that the more exposure this issue receives then perhaps some (positive) action can be taken.

  15. Dear Carol, I am so sorry to hear about this very stupid decision the FDA took. I remember an earlier conversation we had where we just noticed that everything is about money and business.

    Unfortunately not you have to think about alternative solutions to keep getting it. Would it be possible for you to travel to Europe, get the medicine and fly back to the US to keep being close to your family? I know that this would be pretty expensive but at least less than receiving Avastin in the US at your own expenses ($88,000 you said)? The other idea to create a fund could work as well.

    I guess what I am trying to say is: don’t lose faith and hope because there is a solution, we just need to explore the different options available.

  16. @radhaa- ‘basically what this ruling amounts to is ” we don’t think the cost is justified” .. basically they are saying it is not worth paying so much money to extend a life the 3,4,5,yrs ….’

    I don’t know, I’m not a doctor but I thought it seemed pretty clear that the reason was they didn’t find the benefit to be worth the risk, not the price. As I understand it this drug would have never been on the market in the first place if not for the accelerated FDA approval. So now they have done the research for the approval and they didn’t get the data that they’d been promised so they pull the approval. They may be completely wrong BUT I don’t think it’s fair to say that the reason was based on the monetary cost. If it is then I think that if Genentech cares about the patient and believes in the drug then they would make it affordable.

    I just really hope that they are all busy working on this stupid disease because I have had just about ENOUGH of it (we just lost my 51 yr old cousin to cancer :-()

  17. @lynn — no thats the polished version 🙂
    no there is no proof either way on avastin,but there are plenty of cases where it has retarded tumor growth.
    Again sideeffects are there in every drug ( even aspirin) but is it worth to you to extend your life say 6months more or a yr more??? I’d say leave it up to the patient to decide.

    As for genentech – their drug , they can bill what they want, their justification is the funds are used to fund other research — which may be true or not but i know that if they have no money no one will fund drug research 🙂

    Likei said bottom line is money .. i don’t know if there wil be a cure in my lifetime but i sure hope the next batch of kids at least nail this disease..

  18. @radhaa – ‘I’d say leave it up to the patient to decide.’

    Sure, I would agree with that, but then what is the point of the FDA?

  19. Dear Carol, I am so sorry to hear this. I just wish they would leave these things more to the discretion of the physician and patient. Can you get it from Canada perhaps? All the best finding a solution.
    Sandy

  20. I read there is still a company which is willing to pay for it but I don’t know how American insurance system works

  21. America has a rule that you cannot buy medicines outside of the country, so as to keep prices high and profits for the Pharmaceutical profit at the highest. But I suppose Avastin would be expensive wherever you buy it. 😦

  22. @lynn – The FDA is a regulatory authority of control.. say for instance if you or me decided that we have invented a cure for cancer put it out inthe market , I agree they are very good and a necessity, I only disagree with the rulingin this case. especially since the drug holds geat promise elsewhere, My oncology collegues beleive they don’t have a complete handle on how this disease morphs yet. and are open to trying many combinations of which this is one. I think this decision is best left between the physician and patient and on a case by case basis.

  23. @Radhaa – thanks for your excellent explanation of how the system works.

    To me it was a real slap in the face when the FDA made its decision since there are known cases (like mine) where Avastin has been making a difference.

    Part of what any good doctor does when administering or ordering any drug is to monitor for any indication of side effects. Most chemos have worse and more dangerous side effects than Avastin yet the chemos continue to be administered.

    I see my doctor next week and look forward to our discussion on plans. Through most of my battle I’ve remained positive but now I am scared since my lifeline was pulled away without a viable alternate in place.

  24. @radhaa – ‘especially since the drug holds geat promise elsewhere,’

    Which is why they DID approve it for the other cancers just not for metastatic breast cancer.

    Carol, I don’t know why but I just have a feeling that you WILL get it if your doctor feels that it is necessary for you. Or, perhaps there will be something else that will be even better for you. I wish you all the best. Stay positive, that is one of the most important things.

  25. I do want to say how much I appreciate all the comments on setting up a fund. Unfortunately that is not an option either as that would likely impact on ongoing insurance coverage.

    The annual San Antonio breast cancer symposium is taking place and thus far there has been some interesting news coming out from there. The results of studies were presented on other options for women with metastatic breast cancer. Now the key question is when the drugs discussed can be available.

  26. I am sorry, folks but, as a person who works in science I can tell you that is not how the FDA operates.

    The FDA is a U. S. public health, regulatory agency that looks out for the public interest to make sure that drugs, medical devices and the food supply are as safe and effective as possible. They do not work for the pharmaceutical companies or individuals.

    Note that the decision, based on clinical trial research, was 6 to 0. If and when additional research proves otherwise, they may change their ruling. The FDA does not work with individual cases but for general public health. There are always exceptions as to how individuals respond to whatever drugs. Most physicians are not research scientists.

    I am not a fan of Big Pharma, however, the pharma companies would prefer to have the drug used for all sorts of treatments, off label or not. Genentech lobbied against this decision. If the drug is not used, they do not make money. The insurance companies, OTOH are another matter. That way they do not have to pay.

    According to the FDA: …”After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.

    FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.  Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That hearing took place June 28-29, 2011…” More info: http://www.fda.gov/NewsEvents/Newsroom/ucm279485.htm

    Individuals can contact the FDA ombudsman for a complaint regarding human drugs at the Center for Drug Evaluation and Research at 301-594-5443. Also contact the FDA Office of the Chief Mediator and Ombudsman at 301-827-3390.

    There are always workarounds. Carol and her physicians should explore those.

  27. I see that the Department of Health and Human Services can VETO an FDA ruling.

    http://www.cnn.com/2011/12/07/health/hhs-morning-after-pill/index.html?iref=allsearch

    Give that FDA ombudsman a call.

  28. My oncologist spoke at the rebuttal hearing. I had hoped to go along to provide my own testimony but was unable. You had to be at the hearing or hear about firsthand from one who was there. It was clearly evident that the FDA panel had a predetermined mindset before hearing any of the testimonies. Two of the panel members actually fell asleep while testimonies were in progress! I lost much respect for the FDA after this hearing.

    I am active with a group of individuals who have made appeals to the FDA ombudsman. Try getting a response! Hah!

    There are individuals, including myself, who have been “Avastin super-responders” but thanks to the FDA that lifeline was abruptly cut.

    Some new potential drugs have emerged from the San Antonio breast cancer symposium but guess what…these drugs are also pending FDA approval…and if approved, cost about US$10,000 per month.

  29. I am so sorry for your troubles, it makes my heart break. Inshallah, you can find the drug in Canada, UK, or Europe and be able to get it. I do not know much of your situation, but I will pray for you.

    Salaam

    Gwendolyn

  30. Carol, in case you have not seen these:

    Why The FDA’s Rejection Of Avastin Is Good For Medical Innovation

    http://www.forbes.com/sites/matthewherper/2011/11/18/why-the-fdas-rejection-of-avastin-is-good-for-medical-innovation/

    Did The Obama Administration Throw The FDA Under The Bus? http://www.forbes.com/sites/matthewherper/2011/12/09/did-the-obama-administration-throw-the-fda-under-the-bus/

  31. Here is the article which was written after my Dr. and one of his other patients returned from the hearings:

    http://www.huntersvilleherald.com/news/2011/07/07/will-outcry-sway-federal-official/

  32. @Carol – That article you posted said: ‘Patients got some good news this week when Medicare officials announced they will continue covering Avastin treatments for breast cancer, even if the Food and Drug Administration withdraws its approval. But patients, like Shannon Morgan, who depend on private health insurance don’t have that reassurance.’

    Are medicaid and medicare different? Or was that article wrong?

  33. Medicare/Medicaid withdrew its approval last Friday. The article was dated earlier.

  34. If you worked for the CIA, then why are you on Medicaid? Did your or your late husband not have insurance, Carol?

    What about the rich Saudis? Do they have medical insurance for you?

  35. @Prosciutto – those are questions I choose not to answer. It’s a long story and circumstances change. However, after my husband passed away all benefits which were provided by his employer were cancelled.

    Call me strange if you want, but I do not think it is appropriate to appeal to someone just because they are prosperous. I believe if someone wants to give it should be spontaneous and from the heart without asking.

  36. They don’t always know who to give too unless an appeal is made first.

    Sad reflection on our govt when a former employee of the CIA is left out in the cold without the medical care or drugs she needs. Very sad.

  37. @Coolred – Sad reflection on our govt when a former employee of the CIA is left out in the cold without the medical care or drugs she needs. Very sad.

    You know that is not a true statement. Clearly Carol has been able to get on Medicaid and she was getting the drugs she needed and she will continue to get the drugs she needs (as long as they have FDA approval, that is).

    How many people do you know that leave their jobs (without retiring from it) and then years later, when what they left for falls apart on them, can come back and say they want that medical insurance that they had on the job?

  38. Thanks, Lynn. You gave an accurate explanation.

  39. American Bedu, said: 
@Prosciutto – those are questions I choose not to answer. It’s a long story and circumstances change. However, after my husband passed away all benefits which were provided by his employer were cancelled.

    I didn’t mean to pry or to offend, Carol.

    All the more reason for a single payer system that is not tied to employment. Most developed nations in the world have those and their health care stats are much better than those of the U. S. About 40% or more of medical costs are directly related to insurance payments. Most physicians will cut that much off the bill if one pays cash.

    In the U. S. there are electable spousal survivor benefits, especially for government employees. http://www.opm.gov/insure/health/index.asp

    I thought you said that your late husband worked for the Saudis? Apparently, the heart of the employer is not in the right place. I think the canceling of benefits was not only wrong, but also immoral and completely unethical, especially for such a “family” oriented society. My personality would not have let it pass. I would have gone public since I do not believe in waiting for God to give people their just desserts. Shame does wonders sometimes.

    Thank goodness there is Medicaid. I hope that there will be a solution, a better solution with your course of treatment. If I can assist you with any research don’t hesitate to ask.

  40. Carol, I’m curious, did Abdullah’s insurance cover his treatment outside of KSA? He was still alive and being treated here when you began your treatment here (which is WHY you happened to be here in the first place) so did you begin your treatment with the Saudi insurance and then they cut you off after he died?

  41. Yes, Lynn, that is correct. Within Saudi Arabia we both received free medical care. Thankfully his employer had an excellent insurance program for outside of the Kingdom. Abdullah’s medical costs exceeded US$2.5 million. When my cancer relapsed while we were in the US my medical costs were covered too. But medical benefits were discontinued ten days after his death. That is the regulations of his employer regardless of the fact I was in active treatment. However his employer was not heartless and did help some towards bills that mounted up when I had no kind of insurance or resources.

    I was on a leave of absence from my Saudi employer when we came to the States but under my contract with my Saudi employer I only received medical care when I was in the Kingdom. So to make the long story short when Abdullah passed I was not employed or receiving an income. Thankfully I eventually qualified for Medicaid which has covered the majority of my expenses.

  42. @Ab
    You being an amreican you dint receive any medical benefits form armeican govt?

    You were not a citizen in saudi but were on a visa sponsored by husbend ?

  43. […] multiple traditional treatments such as chemotherapy and radiation.  I was also on the drug, Avastin, for a year before it was rescinded by the Federal Drug Administration (FDA).  I am now enrolled […]

  44. […] I have been battling cancer since 2008.  I’ve taken readers step by step through the highs and lows of my journey.  I shared how my cancer was initially discovered and treated while living in Riyadh […]

  45. […] battling cancer since 2008.  I’ve taken readers on my blog step by step through the highs and lows of my journey.  I shared how my cancer was initially discovered and treated while living in […]

  46. […] battling cancer since 2008.  I’ve taken readers on my blog step by step through the highs and lows of my journey.  I shared how my cancer was initially discovered and treated while living in […]

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