The FDA considers revoking its approval for breast cancer drug for cost reasons

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Sarah Palin coined the term “death panels” when she wrote about the rationing that would inevitably occur with ObamaCare. She was immediately slammed by ObamaCare supporters for fear mongering, but the term stuck because people understood what she meant: people’s lives hang in the balance as bureaucrats sit in government offices deny coverage and treatment in an effort to reduce costs.

We didn’t even have to wait until 2014 for ObamaCare to be fully implemented to see these death panels. Already the FDA is considering revoking its approval for Avastin as a treatment for women with advanced breast cancer because of issues with the drug’s cost. Determining whether a drug is or is not too expensive isn’t in the FDA’s purview. It’s job is to make sure the drugs are safe and effective. With ObamaCare, it’s hard to shake the words death panel.

The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.

Citing a dearth of evidence of the drug’s effectiveness, its potential toxic side effects and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin’s authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, women taking the drug, some members of Congress and advocates for giving patients as much access to as many treatments as possible.

The FDA is not supposed to consider costs in its decisions, but if the agency were to rescind approval, insurers are likely to stop paying for treatment.

“It’s hard to talk about Avastin without talking about costs,” said Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs.”
I can’t help but think of the Ford Pinto. Just like Ford’s bean counters, the FDA is making decisions based solely upon cost rather than on saving lives.  If the FDA decides to rescind its approval, it will affect all breast cancer patients, not just Medicare or Medicaid patients because health insurance companies will stop paying for it. But what about those who have the money to pay for it on their own? If it is no longer FDA approved, doctors probably won’t even prescribe it. So, every person who is suffering from metastasized breast cancer will die sooner.

The Susan G. Komen Foundation has responded:

In a joint letter sent to the FDA and key Congressional lawmakers Thursday, Komen for the Cure and the OCNA wrote, “We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”

“We recognize the benefits of Avastin overall are modest for women with metastaticbreast cancer,” said Ambassador Nancy G. Brinker, Komen’s founder and CEO, in the joint letter to the FDA. “However, we do know that for some women, Avastin offers a greater than modest benefit. We hope that this decision will not restrict access toAvastin to all patients.”
The sentence about drug development is very important. All new life saving drugs are expensive for a while, but as pharmaceutical companies make additional advancements, the prices will come down. However, with the FDA beginning to make decisions about a drug’s approval based upon cost considerations, pharmaceutical companies will be less likely to spend up front the millions of dollars that are required to discover each new drug.

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Posted by on August 17, 2010.
Filed under Health Care.
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You can read more from Kim at KimPriestap.com.

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  • 914

    The narcissistic dumbo eared fool gets clue x 4′d with another dose of reality.

    The dumbocrats are all for death panels since they decide who lives ( donors ) and who dies ( conservatives ), the elderly and disabled that can no longer fund thier socialist utopia.

  • epador

    The treatment has minuscule to non-existent effects in breast cancer. The major benefit most patients who receive it is “knowing they’ve tried everything.” It IS a waste of money.

    Should the FDA have mentioned cost in its reasoning? NO!

    Should Medicare refuse to pay for it for breast cancer? YES!

  • Dane

    “narcissistic dumbo eared fool”

    Lets talk about the President’s ears and not let facts get in the way of the right wing slobbering…

    The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.

    Ooops – facts. My bad…

    Butt really, just wail and cry and lie and bullshit – it’s the only chance you have to squelch the truth.

  • jim m

    Epador,

    The question isn’t whether it has a cost benefit analysis that works. The question is do doctors have a legitimate reason for using it and does it offer benefit to some patients?

    The problem is that the FDA having granted Pre-Market Approval for a drug (a process which costs the drug companies 10′s of millions of dollars to go through), they now have decided to make a bureaucratic decision not based on science but by economics. To get a PMA you have to show safety AND efficacy. The FDA is now signalling that they will make decisions based on solely political concerns.

    Do you really want to defend the FDA making political decisions on health care, even if there may be a different way of justifying their decision?

    THIS is exactly what everyone warned about obamacare. It will take the decision making about health care and drug discovery and politicize it. Companies that contribute will get approvals. People that don’t won’t get treated.

    Welcome to Stalinist America. Enjoy it while you can.

  • davidt

    When Avastin is outlawed only outlaws will have Avastin. And connected people.

  • RKemp

    This is garbage. The FDA has no business considering cost in evaluating drugs.

    Considering cost in these decisions could stunt future production: the pharmaceutical companies have to charge a high price in the beginning to offset the enormous costs of producing these drugs. If the FDA is willing to ban a drug based on its cost, then the pharmaceutical companies aren’t going to want to take a chance on a product they’ve put millions into getting rejected. The cost factor may be only part of the reasoning now, but the FDA’s headed down a slippery slope: they’ve opened the door to using cost and cost only as a consideration in drug approval.

    I would like to know how often these toxic side effects occur, and why. Are these side effects the result of something poisonous in the drug, or are they a result of a violent allergy to a chemical in the drug. You’ve got to remember, there are people who can die from eating peanuts.

    As for the negligible benefits, according to the spokesperson for the production company (I can’t remember the name off the top of my head), the drug has a 31-52% efficacy rate. Considering that this drug could save someone’s life, or at least prolong it, I’d be willing to bet that a lot of cancer patients would be willing to take a chance on 31-52%.

  • Caesar Augustus

    The FDA is from the government and they’re here to help….

  • GarandFan

    “The Food and Drug Administration is reviewing the recommendation of influential scientific advisers….”

    If the FDA is going to act on the advice of these people, shouldn’t we know WHO they are?
    If someone is going to recommend a bureaucratic act which may end my life, I’d like to know WHO that individual(s) is.

    Let’s face it. Eventually it will come down to which costs more, pain medication or drugs to prolong your life. Don’t think so? Well Barry himself was thinking that when his grandmother died. Hell she was dying of cancer, why did they spend all that money on hip replacement. I’m sure grandma would have understood.

  • Gmac

    Coming to you sooner than you thought, a panel that will justify your existence. Courtesy of the Democrat party lock, stock and barrel.

  • SER

    Dane’s quote:

    “Butt really, just wail and cry and lie and bullshit – it’s the only chance you have to squelch the truth.”

    Dane,

    “But,” as used in this context, has only one “t.”

  • Dane

    “”But,” as used in this context, has only one “t.”

    My use of “butt” was intentional, and it applies to the drooling troll in comment #1. What the f*ck do Obama’s ears have to do with anything?

    Actually “Butt Hey” is a favorite saying of mine. Butt Hey is what you find stuck to the seat of your jeans when you’ve been sitting on hay bales.

  • http://www.wizbangblog.com Michael Laprarie

    There was an interesting discussion of this yesterday at Ann Althouse’s blog. A commenter noted that she was being treated for advanced ovarian cancer (not breast cancer) with Avastin as part of a clinical trial. The average rate of survival for patients with her particular type of ovarian cancer is 18% after two years; she has just passed the two year mark and so far is in reasonably good health.

    Kim, you said this story reminds you of the Ford Pinto and Ford’s absolutely unconscionable (according to liberals) decision to put a dollar value on human life.

    For me, this story brings to mind one of the traditional liberal arguments against the death penalty — liberals claim that it is immoral to make a decision that could potentially lead to the death of an innocent person, especially if that person’s life could have been saved, had a different decision been made. (I specifically remember Mario Cuomo telling a reporter in a TV interview that he “wouldn’t be able to live with himself” if he signed an execution order for a prisoner later determined to be innocent.)

    Isn’t this the same thing, relatively speaking? Liberals routinely claim that the morality involved in protecting the life of an innocent man transcends all other surrounding circumstances; that there is no compromise worth the price of a human life. Liberals defend costly (and in many cases completely impractical) environmental mandates by arguing, if we save even one life, it will have been worth it.

    Where are those voices now?

  • SER

    Dane,

    On this site, you are the troll. Nice try at explaining the lack of English skills, though.

  • Jerry Chandler

    Actually, the costs of the drug were not part of what they were looking at. They have come up in the debate, but they were not the reasons that the FDA might be revoking approval of Avastin for advanced breast cancer.

    The simple facts are that it was fast tracked into approval under a program that required more study for continued approval. The studies it had when given approval in 2008 were mixed and only one showed it to be of any real use. Later studies have shown that it isn’t what the one study made it out to be. It has very little to offer over other drugs already out there and it has shown to be a risk for causing blood clots, bleeding and heart failure.

    No death panels. Sorry to have to stick a little reality into your death panel fantasies.

  • GarandFan

    “It has very little to offer over other drugs already out there and it has shown to be a risk for causing blood clots, bleeding and heart failure.”

    Tell that to the one’s being helped by it. In the area of medicine, ‘one size does not fit all’. But in the bureaucratic world, one is not encouraged to use initiative or THINK.

  • epador

    Many of you are succumbing to emotional reactions and ignoring what I stated as well as what has been reiterated by Jerry Chandler in 14.

    You are behaving like Kos Buddies, Get your game on before you lose in entirely.

  • 914

    Dane-

    Lets talk about the President’s ears and not let facts get in the way of the right wing slobbering…”

    How do you know I was referring to Barry?? Do his ears give him away?

  • epador

    If a treatment harms many/most of the people that receive it, and an insignificant (statistically) portion benefit it is generally considered ineffective and is not FDA approved.

    I’ve seen those rare patients that were cured by a treatment abandoned after early trials showed significant toxicity and less than 5% response rates. They were extremely lucky to be in the right place at the right time.
    That they benefited and the treatment was abandoned does not make abandoning the treatment regimen wrong. It saved countless patients from being treated with something that harmed them and did not work.

    Sorry to say folks, but that is how the scientific method works.

    Remember all the brew-ha-ha about autologous stem cell transplants with high dose chemotherapy for breast cancer? Organizations LIKE Susan Komen pressured insurers and the government to make this a benefit. After hundreds and hundreds of women underwent this treatment, it was found to be no more effective than conventional treatment, and much more harmful. After only a few years it was finally abandoned, but not after torturing, maiming and killing hundreds of women. And yes, it was VERY expensive.

    I fear that the Avastin in breast cancer story will ultimately turn out much the same, only now it is being hitched to the anti-ObamaCare wagon, which will only degrade the argument against the ObamaCare travesty.

    Rant all you want, but the Kos analogy, as painful as it may seem, is appropriate here.

  • hyperbolist

    So Kim is wrong, now it remains to be seen whether she’ll correct her post or leave it as is–which would be a lot like telling a lie.

    Fun fact: your country’s healthcare system is shit.

    http://www.newsweek.com/2010/08/15/interactive-infographic-of-the-worlds-best-countries.html

  • http://opiningonline.com Donna B.

    Read what the manufacturer says about the effectiveness and side effects of Avastin:
    http://www.gene.com/gene/products/information/oncology/avastin/avastin-bc-facts.html

    “Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer.”

    FDA approval does not mean an insurance company is going to pay for a drug does it? Every insurance company is going to look at using Avastin very carefully and that’s not necessarily a bad thing. There are only certain types of tumors under certain circumstances where it’s been shown effective.

    Effectiveness defined as 5 months additional life under the best circumstances (for colorectal cancers). The nasty side effect profile must be considered too.

    Avastin is not a miracle drug. Describing it’s effects on any cancer as modest is a euphemism for just barely worth the risk of taking it if it were completely free.

  • john

    It’s hard to know if Kim is being sloppy, intentionally lying, or just completely clueless.

    First, note the claim:

    the FDA is making decisions based solely upon cost rather than on saving lives.

    Really? “Solely”? Are you so desperate for an Obamacare story that you’re going to flat-out lie, even as you yourself provide the evidence of your lie?

    Check your own article excerpt again.

    Citing a dearth of evidence of the drug’s effectiveness, its potential toxic side effects and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin’s authorization for breast cancer might be repealed.

    It appears that “dearth of evidence of the drug’s effectiveness” and “its potential toxic side effects” don’t count to you, since all you see is that the decision is “solely” on the cost.

    Now for your big lie. Read your excerpt again, and tell us exactly who does the article say is citing the drug’s cost. Is it the FDA? NO! It’s “many cancer experts, patient advocates and others”. In other words, there’s no indication WHATSOEVER that the FDA is considering cost in this decision. Indeed, as other commenters have noted here, it is a reasonable medical decision. And your article itself points out that “the FDA is not supposed to consider costs in its decisions” with absolutely no claim that it is doing otherwise.

    So just where the hell are you getting “The FDA considers revoking … drug for cost reasons“?

    Shame on you.

  • SER

    Hyperbolist,

    Newsweek? Really? How about sourcing an opinion piece from “The Nation?” Maybe “The New Republic” if you want to go to the far right.

  • hyperbolist

    SER, if there was a single objective metric that touted the United States’ healthcare system as superior to that of Canada’s or France’s or England’s or Japan’s (or any Scandinavian country’s), you’d have memorized it by now. There is no such thing, though. Your healthcare system is shit because of ideological convictions of people like you. Nice work!

  • SER

    Hyperbolist,

    The only objective metric I have is the number of Canadians crossing the border for medical treatment. The lovely and talented Mrs. SER is from Buffalo and the hospitals in that city accommodate many Canadians. I am sure that you have many stories of Americans heading to the Great White North for treatment, Eh?

  • hyperbolist

    No, SER, they go to Thailand and Mexico.

    http://www.tampabay.com/news/health/medical-tourism-draws-more-us-patients-to-travel-for-care/1079824

    That’s a greater proportion of Americans going elsewhere for medical assistance than Canadians (not counting inter-province medical treatment and diagnosis–so the proportion is probably similar, but we pay half as much and enjoy better outcomes and don’t have uninsured children making us look like a 3rd world country).

    FUN UPDATE: Kim was called out for lying about the reason for this shitty drug being discontinued a day and a half ago and has yet to retract or update the post. NIce work, editors! File this e-turd next to Kim’s Ashley Tood humiliation. Personally I’d hate to be associated with a writer who is completely devoid of integrity but then I’m not selling ads on this blog so what do I know. Maybe bullshit is good for site traffic.