USA/KSA/World: FDA Decision Determines Who Has Right to Life

This is an emotional and very personal post.  The United States Food and Drug Administration (FDA) announced today (a day earlier than scheduled no less) that it is withdrawing the drug Avastin from the market.  Avastin is the most common and popular drug administered to patients who have been diagnosed with Metastatic Breast Cancer (MBC), like me.

Avastin works by starving the cancer tumors in not allowing blood to flow to them and “feed them,” which allows the cancer to grow and spread.  Without Avastin and blood flow once again restored to the tumors, the effect will be very similar as to one who has been wandering in the desert and finally finding water.

Taking Avastin away, the FDA has literally signed my and many others death warrant if this ludicrous decision is not somehow revoked.  Genetech, the manufacturer of the drug, has appealed the decision of the FDA.  However in the interim, many women like myself are in a state of shock and asking themselves, “When did the FDA receive the right to determine who has a right to a prolonged life or not?”

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35 Responses

  1. This is sad. They should warn people with lethal illnesses about its side effect, but give people choice to use it if they chose to do so.

  2. I was told about the possible side effects prior to receiving Avastin. However now it seems I have no choice in the matter.

  3. I’m so sorry you are experiencing this distress! Did they say why they are doing that? May it work out in your favor.

  4. A doctor friend of mine was telling me that Avastin doesnt prolong life…it just improves quality of life for a period of time. It wasnt tested properly before entering the market…and now that it has been its been deemed unsafe….so is being withdrawn.

    Here’s a link for those interested.

    http://www.latimes.com/health/boostershots/la-heb-avastin-20101216,0,6362880.story

  5. Oh, Carol, I’m so sorry and sad to hear this. I pray for other options and a replacement better than this.

    My sincerest duas are with you and others who were depending on this drug as the most effective treatment option.

  6. There is no proof that avastin extends life long term, however there are no otehr drugs that extend life short term as avastin. Inspite of the side effects ( which are many) It helped many patients and it is still valid and in use to treat many otehr forms of cancer.

    Don’t worry carol, your oncologist will not just stop this, he/She will put inplace altrnate protocols before getting you off this drug.

    Keep your spirits up

  7. oh Carol 😦

    This makes me sad on your behalf. I hate that the FDA often plays God with the lives of American people. They don’t even do a GOOD job of it. *sigh* I hate that you even have a death sentence pending. This world will lose a good, bright, lovely part of it if you are no longer here. Perhaps um… a trip elsewhere where it is not banned? I know Thailand tends to sell just about every drug (class 4 included) in it’s little mom and pop stores. Mexico often does the same. I’m sure the pharm co will be off loading this drug to the rest of the world. Worth a try! Maybe the some of us in the US can do a car traveling caravan for us up to Canada or down to Mexico.

  8. Can you order from Canada? This is outrageous! I am so angry at the stupid FDA! >>>:-[ Whatever happened to people being free to take what they want? My goodness, you’d think we had some sort of Nanny Government around here or something! Grrr!

  9. Thus far, Avastin has been working well for me. My oncologist is one of the few who correlate findings with what is called a circulating tumor cell test. Prior to Avastin my CTC count was high. Since Avastin the count went down to zero! This test is administered monthly and as of this past Wednesday my CTC count was still zero. Avastin is working and giving me additional quality of life. The alternative is back on chemo. ):

    I may not know what this decision is going to do to my particular situation but I do have faith and strength. Additionally, I am a fighter.

  10. I am confidant that you will still be able to get this treatment that works for you.

    Don’t allow yourself to get stressed out over this and keep your immune system strong with super nutrition. There is a Dr. in NC that believes he has a cure for cancer based on a nutritional supplement. (Dr. Ellis Kline (or Cline?) )

  11. Sigh 😦

    InshaAllah you and your oncologyst will pull through this one. Stay strong Carol, you are in my thoughts and duas!

  12. I am in the information gathering stage towards learning what options are or will be available. What I do know is that my Avastin treatments are $18,000 per month and I sure can not self-pay that amount!!!

    I hope that there is a chance to be “grandfathered” since I am an existing patient and therefore treatments would not be halted but that is my hope not necessarily the reality at the moment.

  13. Well, that sucks.
    😦

  14. Omg… :-(((( Can you get it from Canada? Can you stock up on it? That’s insane why did they take it off???? :-(((((((((((( My mom is battling three different cancers as well, I can’t fantom what I would if they stopped her treatment. I’m so sorry :-((( Be strong and fight! You mean too much to so many people.

  15. Hi,

    That’s too bad about the meds. I never realized that they were that expensive. Wow.

  16. salamat Carol,

    I hope that you and those who suffer from breast cancer will be compensated with a more effective treatment. Allah yishfeeki.

    My best friend’s mother died from breast cancer almost 3 years ago. My aunt died from breast cancer almost 25 years ago. I try to go to the annual walkathon in Dubai, though I missed this year’s.

  17. It does suck! I’m still waiting to hear on the available options and especially what the drug company is going to say.

    Avastin is not just like taking a pill. It is actually an infusion that is made up for an individual depending on weight and other critical data such as blood counts and urinalysis. It is then administered via IV.

  18. ((( Carol )))

    I wish I could give you a real hug and make this all go away for you.

    Just know that I care, you are in my thoughts and prayers.

    I hope your doctor will have better alternatives and ease your anguish with this distressing news.

  19. @Aisha’s Mom,

    Thank you!

  20. Is there something the ‘common folk’ can do to help?

  21. Anyone interested in voicing their opinion about the Avastin decision can write directly to the FDA to have their comments submitted as part of the FDA docket. The docket number is FDA-2010-N-0621. Comments are due February 14, 2011 by 11:59 p.m. ET.

    http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm237169.htm

    Electronic:

    1. Go to http://www.Regulations.gov

    2. In the “Enter Keyword or ID” box, enter: FDA-2010-N-0621 and hit “Search”

    3. Next screen will show docket title in blue text (“FDA/CDER to Genentech, Inc. – Letter”)

    4. Click “Submit a Comment” on the right side, under Action

    Mail:

    1. Provide four copies of your comment/statement regarding the FDA decision on Avastin in metastatic breast cancer and label each copy with: Docket No. FDA-2010-N-0621.

    2. Send to:

    Division of Dockets Management (HFA-305)

    Food and Drug Administration

    5630 Fishers Lane, Room 1061

    Rockville, MD 20852

  22. Ugh.

    We are currently conducting planned system maintenance that began at 6:00:26 AM on December 18, 2010 and should be complete by 2:00 PM.

    We appreciate your patience as we work to keep the site operating at peak performance.

  23. Avasting this very controversial drug amongst law enforcing bodies and the medical users of doctors and patients! You may not know but this has become the most widely injected drug now into the eye for treatment of numerous retinal vascular disorders as well as age related macular degeneration ( CNV). Though it is WIDELY used by all, it yet needs to be approved for its new current useS, by many goverments…it is approved for rectal colon cancer.

  24. Avastin does have side effects, you will find it in europe and the middle east. Retina specialists use it widely.

  25. I am not sure if you have seen this video; its really interesting.

    http://www.3news.co.nz/Living-Proof-Vitamin-C—Miracle-Cure/tabid/371/articleID/171328/Default.aspx

    There are other interesting videos there about studies for cancer treartment.

  26. Oh no that is awful!!
    I wonder if its available in Saudi??Not sure if they’d give and IV solution over the counter although most drugs are easy to get here as you know, but
    I could ask an oncologist to help get it for you and send it over what do you think?

  27. I am very sorry to read about this Carol. I do hope that there may be a way for you to still receive the medication, or that they find a better substitute enshallah.

  28. The have been several studies showing that large intake of vitamin C is greatly beneficial to cancer patients, in Japan (the best health care system in the world) vitamin C and Gerson therapy are done in hospitals.

    Big Pharma hates it because nutricion and vitamins cannot be patented, will never be cash crops, and are readily available for who-ever needs them.

    Carol, I changed my mind, I will not be making ”poffertjes” for you because white sugar feeds cancer cells.
    I will however make you fruit and vegetable juices.
    Sorry.

  29. Avastin is available in KSA

  30. Thanks for confirming that Avastin remains available in the Kingdom. I was wondering about that.

    This would not be a medication that would be available over the counter from a chemist as there needs to be bloodwork and urinalysis performed before administering. Then the dosage is dependent on these factors plus weight.

  31. Let me confirm where you can find it, and i’l get back to you on it.

  32. Update: While the dispute between Genetech and the FDA is going on, Avastin will continue to be available to those who have been receiving it. However the question which is waiting an answer is whether insurance(s) will continue to cover the cost.

  33. I have always thought insurance companies in America were getting too big for their britches (among other organizations, to be sure). I hope that this stupid decision is overturned, or at least that its enactment will be postponed until a better option can be offered. This is so unfair and I wish I could really do something to help!

  34. I encourage everyone to send their opinion to the FDA of this issue. In an earlier comment I provided the links. I used the email link and did not mince words in expressing my view!

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