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“Stop the FDA from Disproving Avastin to treat metastatic breast cancer”

This is a taste of our collective futures.

But don’t you dare call them death panels. That’s just tawdry.

39 Replies to ““Stop the FDA from Disproving Avastin to treat metastatic breast cancer””

  1. epador says:

    For breast cancer, Avastin isn’t all that effective, it is very toxic, it is very expensive. The site linked is histrionic and inappropriate. It is appropriate for Avastin to not be indicated for breast cancer. I am a Board Certified Medical Oncologist with 30 years experience.

    It would be more appropriate to belittle the FDA for harassing the manufacturers of propoxyphene, a wonderful placebo, resulting in its being withdrawn from the market this month. I have my appointments filled with hysterical little old ladies that will have to take plain acetaminophen instead.

  2. Jeff G. says:

    This morning, the FDA announced that it is withdrawing approval of a drug called Avastin for the treatment breast cancer. Tens of thousands of families will be devastated by this move. One of those families is mine. Three years ago, my mom was diagnosed with stage IV breast cancer. Avastin literally saved her life. Today, doctors can’t find any trace of the disease in her body. Now that the FDA has pulled approval for the drug, health insurance plans could stop covering it. Families like mine might not be able to afford this treatment any longer. Over 9,000 people have already signed my mom’s online petition (http://www.thepetitionsite.com/3/stop-the-fda-from-disproving-avastin-to-treat-metastatic-breast-cancer/).
    I can only hope and pray that the FDA will reconsider.”

    Josh Turnage

  3. Jeff G. says:

    More:

    Yet a clinical trial showed a 52% median improvement in “progression-free survival,” which measures the time women live without their disease spreading or worsening. In practice, this means delaying the growth of tumors by about 11 months in combination with chemotherapy—five and a half months longer than chemo alone.

    Metastatic breast cancers remain incurable, so the main goal is to improve quality of life: Oncologists try to control the spread of cancer and delay the onset of symptoms. Having more than one treatment choice is itself a real benefit for patients, minimizing psychological suffering and offering hope.

  4. cranky-d says:

    You proles need to be satisfied with whatever treatment regimen is the cheapest. Also, get used to the idea that there will be no new treatments for you, because they cost money to develop, and we’re not going to let companies charge you the kinds of money that will actually pay for development costs.

    You’re welcome.

    [/people who know what’s good for you]

  5. happyfeet says:

    the point really kind of is that if we’re going to have dirty socialist health cares then we’re going to have to accept that we’re going to have a less healthy higher-mortality society

    That’s the only way it works.

  6. Jesus. These guys don’t even like tits.

  7. McGehee says:

    I find it hard to take seriously any feminist bunch that doesn’t understand the difference between “disapproving” and “disproving.”

    And, yeah, that sentence could be a lot shorter, but I wanted to include the part about “disapproving” and “disproving.”

  8. AJB says:

    Forbes:

    Due to severe state budget difficulties, the State of Arizona recently ended a government program that funded organ transplants for those in life-threatening circumstances.
    […]
    Literally overnight, terminal patients who previously had a real chance to stay alive went from hope to despair, consigned to resort to television pitches on news interview programs in an effort to inspire strangers to send in money to fund their life-saving surgeries.
    […]
    ake, for example, Randy Shepherd, a 36-year-old father of three who has reached the end of his ability to survive on a pacemaker. Shepherd’s only chance at life is a heart transplant – something he cannot pay for because he does not have an insurance policy that would pay for the procedure.

    But Shepherd does not find himself in this situation by choice or because of poor or negligent financial planning. The heart problem that threatens to bring his life to an end is the result of the rheumatic fever he contracted as a child.

    Unable to purchase private coverage due to his serious pre-existing condition (a problem that will no longer exist thanks to health care reform), Shepherd had no other option but to go on Medicaid.

    Now, Arizona’s Medicaid program will no longer pay the costs of the transplant.

    Randy Shepherd was already on the list to get a heart when Brewer cut the funding to the program, cuts that totaled $1.4 million, pulling the rug out from under him. Accordingly to the governor, this had to be done because the state “can only provide so many optional kinds of care.”

    Arizona’s way ahead of ObamaCare in the field of death panels. Also:

    the point really kind of is that if we’re going to have dirty socialist health cares then we’re going to have to accept that we’re going to have a less healthy higher-mortality society

    You do realize–of course–that life expectancy in the US is far lower than it is in most other First World countries, right?

    Health Affairs:

    In 1950, the United States was fifth among the leading industrialized nations with respect to female life expectancy at birth, surpassed only by Sweden, Norway, Australia, and the Netherlands. The last available measure of female life expectancy had the United States ranked at forty-sixth in the world. As of September 23, 2010, the United States ranked forty-ninth for both male and female life expectancy combined?

    We already have death panels.

  9. Abe Froman says:

    In 1950, the United States was fifth among the leading industrialized nations with respect to female life expectancy at birth, surpassed only by Sweden, Norway, Australia, and the Netherlands. The last available measure of female life expectancy had the United States ranked at forty-sixth in the world. As of September 23, 2010, the United States ranked forty-ninth for both male and female life expectancy combined?

    AJB misses the days when wimmenz were housewives and cheerleaders and Army nurses. Why does AJB hate modern women being more like men?

  10. Jeff G. says:

    I believe the US is the only country that includes infant mortality in the data, so the WHO data is, naturally, skewed. Plus, there’s this.

    Also, the idea of pointing me to a state ending a bankrupt government program — at a time when the government is fishing for 8.1 billion in pork spending for things like the Ted Kennedy Institute of … something — is rather ironic, I think. Doesn’t really strengthen your argument for universal government run health care, either.

    But thanks for dropping by.

  11. geoffb says:

    When AJB is shown an apple he always jumps up and says “Look at that orange bunny over there!” He’s like that.

  12. McGehee says:

    AJB probably doesn’t grasp the difference between “disapproving” and “Look at that orange bunny over there!”

  13. JD says:

    AJB is Yelverton, no?

  14. Abe Froman says:

    What’s really funny about AJB is that you look at that mammoth text block he left and just know that he couldn’t compose that many intelligible words on his own about anything. He ought to have his copy/paste functions stripped from his browser pending an IQ test.

  15. happyfeet says:

    I used to really like my odds of attaining a respectable longevity.

  16. SDN says:

    AJB, when you recreate the Philosopher’s Stone and brew us all elixirs of immortality, get back to me.

    In the meantime, there are private charities that work on problems like that.

  17. cranky-d says:

    You can get insurance policies that cover pre-existing conditions like this man has. They cost a lot more, of course, but those are the breaks. If you have been unlucky, it’s going to cost you more. I know because I’ve been unlucky, and insurance costs me more. I don’t think that everyone else should have to pay for that.

    Removing the ability to filter on pre-existing conditions will drive the price up quite a bit for everyone. If that will also include people who didn’t ever buy insurance, and wait until they are sick to do so, the prices will become so high that no one will be able to afford it. Then the government will step in, single-payer will appear, and our health care will suck like a Dyson.

  18. JD says:

    ajb diddles underage goats.

  19. Ella says:

    epador, I’m calling BS on you. A) I find it hard to believe that an oncologist is seeing scads of totally healthy old women and has to ply them with placebos to shut them up. B) Avastin is the most common cancer drug in the world. It doesn’t have any more side effects than any other cancer drug. And it’s part of next-gen biomarker drugs — so it is highly effective in some people and not effective at all on others. Your retarded argument is like saying we should do blood transfusions because not everyone is the same type, so not all blood is effective.

    Douche.

  20. Ella says:

    That should be “should not do.”

    Come to think of it, maybe no one should comment on blogs because some people have typos.

  21. Ella says:

    My aunt who supports Obamacare also supports yanking Avastin off the market. It’s “false hope” that prevents women from making the “courageous choice.” And, you know, dying quickly. Seriously, that’s her argument. It keeps women alive too freakin’ long! When they could die!

    I called her cruel and evil and now she’s refusing to see me at Christmas. On the upside, that saves me $20 on her Christmas gift.

  22. newrouter says:

    On the upside, that saves me $20 on her Christmas gift.

    no buy one of these for her

    obama chia pet

  23. happyfeet says:

    how awkward would it be if your aunt got cancer?

    Very very awkward.

  24. geoffb says:

    An epador 4/11/2007.

  25. happyfeet says:

    doctors are almost unfailingly neurotic I don’t get why that is that

  26. happyfeet says:

    speaking of neurotic failshit California is shutting down the porn clinic

    That’s really fucked up. That little clinic actually gives a shit about the people it serves and it has a lot of expertise and is well-positioned to catch trends early.

    True to form California has figured out how to take a bad situation and make it exponentially worse.

  27. The Monster says:

    how awkward would it be if your aunt got cancer?

    Decades ago, I had a conversation with my mother about the War on (Some) Drugs. I mentioned that there were legitimate medicinal uses for marijuana, including the preservation of eyesight in glaucoma patients. She told me if she had to choose between MJ and going blind, she’d go blind. We didn’t talk about MJ’s use in cancer treatment, and by the time it mattered, I didn’t dare bring it back up.

    My mother died of complications of breast cancer 24 years ago.

    Yeah, awkward.

  28. cranky-d says:

    If I had to choose between running drugs for myself and going blind, I’d run the drugs.

    Jeebus. Smoking a joint is nothing compared to not being able to see. That’s just wacko.

  29. ThomasD says:

    Epador, you are either full of shit or a really sad excuse for a professional.

    If you have been prescribing propoxyphene for all your ‘little old lady clients,’ all the while knowing it was not merely worthless, but also dangerous then you need to re-examine your notions of integrity. Never mind the ethics of giving anything without informed consent (kinda makes it hard to use a placebo), you gave them something with zero upside and well recognized risk. I’d love to see you fess up to that practice pattern under oath.

    The Avastin withdrawal is pure politics. There are multiple other drugs, with more serious risk to benefit problems, that the FDA has allowed to remain in use on a compassionate need basis – eg. Enkaid (encainide) which, although it had a real tendency to kill people (that’s why it was pulled from general use) there were a small number of people who were taking it with benefit, and the FDA chose to allow this to continue until they all passed away or otherwise stopped the drug (it was used to treat arrhythmias.)

    The FDA could have easily done something similar for Avastin, particularly since there were no serious safety concerns (and really, how could there be – it is used in the treatment of a rapidly terminal illness), no this drug was pulled as a message from the FDA to future drug development planners – if it’s gonna be really costly then best walk away.

  30. happyfeet says:

    that’s very sad Mr. Monster especially cause of how fast breast cancer treatment has moved… my mom had a radical masectomy in the early 90s and ten years later they told her they wouldn’t do that anymore for the sort of presentation she had. I think she’d be pretty pissed off about president bumblefuck telling breast cancer people to fuck off and die.

  31. Mr B says:

    I’m not too worked up about Avastin with all the alternatives on the market; or soon to be. Avastin was not first line, for breast cancer, and did not perform good enough it seems. It remains for other indications (for now). Calling Avastin toxic, compared to first line agents like Taxol or Doxorubicin, does seem odd to me.

    We just had an introduction to a new second line drug called Halaven. I’m seeing Xeloda more now (without Tykerb). I like that many new agents are being fast tracked: http://www.drugwatch.com/news/2010/03/19/new-breast-cancer-drug-trial-may-speed-fda-approval-times-researchers-say/ And the PARP inhibitors are showing some promise. That class should be “cheap”. /sarcasm

    However, I don’t like the idea of options being taken off the table by a government agency. While off label doesn’t mean we can’t/won’t use it; payment will be the likely challenge. I have empathy for those negatively affected by this decision.

    We see drugs come and go. First and best are expected to survive. I won’t miss Darvon/Darvocet.

  32. Pablo says:

    I am a Board Certified Medical Oncologist with 30 years experience.

    Does it ever occur to you that maybe you’ve been at this for long enough?

  33. happyfeet says:

    onc if you hate socialisms

  34. Pablo says:

    The FDA could have easily done something similar for Avastin, particularly since there were no serious safety concerns (and really, how could there be – it is used in the treatment of a rapidly terminal illness), no this drug was pulled as a message from the FDA to future drug development planners – if it’s gonna be really costly then best walk away.

    It’s still an approved drug, it just won’t be approved for breast cancer. Which means they’re not going to pay for it for a lot of patients, and naturally the gubmint sets the tone for insurers. The Susan G. Komen folks are not impressed.

    This is a very slippery subject, and I’m conflicted about it. There’s a brave new world in cancer drugs developing and it’s all about targeting. They need better knowledge beforehand as to which women Avastin will work for. It’s just too expensive to throw at everyone with an indication. That said, the FDA has no business considering cost as that’s not their job.

  35. ccs says:

    It would be more appropriate to belittle the FDA for harassing the manufacturers of propoxyphene, a wonderful placebo, resulting in its being withdrawn from the market this month.

    From drugs.com …….. Generic Name: propoxyphene (pro POX i feen)
    Brand names: Darvon, Darvon-N, PP-Cap
    What a placebo.

  36. ccs says:

    Well Mr. B beat me to it. That’s what happens when you wander off for a bit and don’t refresh before you post.

  37. LTC John says:

    I sure hope my old man doesn’t see this story (he’s a retired doc). I used to be able to get him to engage in profanity one of two ways – say “politician”, or “lawyer”. Heh.

  38. Ella says:

    Pablo, Avastin is (I understand it) a biomarker drug, but they don’t know all the markers that make it effective. In about 1/3 of women, it increases their lifespan by YEARS. For the rest, it’s not effective at all. There were a couple of decades, IIRC, between when they first started doing blood transfusions and when they began blood typing and could find Rhesius factors. That doesn’t mean they should have stopped blood transfusions; they needed more information, not less. We need more information and, honestly, more exposure to drugs like Avastin.

    My grandfather was diagnosed with terminal lung cancer (in 1986) and willingly went into a chemo experimental group with the understanding that it would probably shorten his life but would give them valuable information about how the drug worked. My understanding is that his test group actually did help with the development of that chemo drug.

    I’m not saying throw Avastin at everything that moves, but being able to let patients experiment with it to see where it works is going to be a good thing in the long run. Cutting off that field of research based on cost is going to kill cancer research and any related medical discoveries that could have accompanied it.

    But it’s all Logan’s Run now, anyway.

  39. ThomasD says:

    Biomarkers don’t ‘make’ a drug effective, they are particular characteristics of health, or disease state, that are suitable for use as metrics of therapeutic efficacy. They are an attempt to move drug research towards measuring the things that really matter for extending lifespan and functional health.

    A simple example is high cholesterol, which has long been understood to play a role in heart disease. While many drugs will ‘move the numbers’ not all of them have been able to demonstrate improvements in reduction of cardiovascular events or increased longevity (which, regardless of what your ‘numbers’ are, are the really important things.) So, in this sense total cholesterol is a poor biomarker for drug efficacy, while years of lifespan post MI is somewhat better.

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