Feds Revoke Approval of Life-Prolonging Treatment for Breast Cancer, Insurers Could Bail on Patients
- Posted on November 18, 2011 at 9:04pm by
Tiffany Gabbay
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For those unfamiliar, Avastin is a targeted therapy drug used in conjunction with chemotherapy in the treatment of certain advanced cancers — primarily colorectal, kidney, and lung, but also breast cancer. The drug works by restricting the blood supply to tumors. The goal is to starve tumors of the precious blood needed to grow, thus shrinking them. While the drug carries with it serious side effects, it has been proven successful in suppressing tumor growth in various types of cancers.
Now, however, the FDA is revoking its approval of Avastin in the treatment of advanced breast cancer only. This means that doctors can still prescribe the drug to breast cancer patients as they deem fit, but insurers now might not cover the exorbitant cost. A year’s supply of Avastin can cost roughly $100,000.
For people with certain types of advanced cancers for which there is no cure, Avastin is sometimes the last-line of defense in suppressing tumor growth and preventing the cancer from metastasizing for a prolonged period of time, improving prognosis.
Now, breast cancer patients who have been receiving the drug with good results are faced with a very difficult challenge ahead, especially if their insurers decide not to cover the cost of treatment. The Wall Street Journal notes the “chillingly blunt assertion of regulatory power against a drug for breast cancer.” In this instance, the power of a federal agency is outweighing doctors and their patients — the ones who have the most to lose:
The extraordinary Avastin saga has become a kind of randomized controlled trial, pitting the Food and Drug Administration’s power against potentially life-saving drugs for terminally ill patients. The results are proving that the former is far stronger, with FDA Commissioner Margaret Hamburg’s decision yesterday to withdraw the biologic medicine as a treatment option for women with metastatic breast cancer.
The details of the FDA’s decision are outlined in the following Associated Press report:
WASHINGTON (The Blaze/AP) — The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.
Avastin is hailed for treating colon cancer and certain other malignancies. But the Food and Drug Administration said it appeared to be a false hope for breast cancer: Studies haven’t found that it helps those patients live longer or brings enough other benefit to outweigh its dangerous side effects.
“I did not come to this decision lightly,” said the FDA’s commissioner, Dr. Margaret Hamburg. But she said, “Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”
Avastin remains on the market to treat certain colon, lung, kidney and brain cancers. Doctors are free to prescribe any marketed drug as they see fit. So even though the FDA formally revoked Avastin’s approval as a breast cancer treatment, women could still receive it – but their insurers may not pay for it. Some insurers already have quit in anticipation of FDA’s long-expected ruling.
However, “Medicare will continue to cover Avastin,” said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. The agency “will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.”
Including infusion fees, a year’s treatment with Avastin can reach $100,000.
The ruling disappointed patients who believe Avastin is helping to curb their incurable cancer.
“It’s saved my life,” said a tearful Sue Boyce, 54, of Chicago. She’s taken Avastin in addition to chemotherapy since joining a research study in 2003. Her breast cancer eventually spread to her lungs, liver and brain, but Boyce says she is stable and faring well.
“So I’m hoping the insurance company will grandfather me in to continue taking it,” she said.
The Avastin saga began in 2008, when an initial study suggested the drug could delay tumor growth for a few months in women whose breast cancer had spread to other parts of the body. Over the objection of its own advisers and to the surprise of cancer groups, FDA gave Avastin conditional approval – it could be sold for such women while manufacturer Genentech tried to prove it really worked.
The problem: Ultimately, the tumor effect was even smaller than first thought. Across repeated studies, Avastin patients didn’t live longer or have a higher quality of life. Yet the drug causes some life-threatening risks, including severe high blood pressure, massive bleeding, heart attack or heart failure and tears in the stomach and intestines, the FDA concluded. In two public hearings – one last year and one this summer – FDA advisers urged the agency to revoke that approval.
“The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman of the National Research Center for Women and Families in Washington.
Genentech had argued the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, and some patients and their doctors had argued passionately for the drug.
“There certainly are patients who benefit tremendously,” said Boyce’s oncologist, Dr. Melody Cobleigh of Rush University Medical Center. “We’ll just be battling with the insurance companies.”
“For those not fortunate enough to be on Medicare or an insurance plan that covers it, it’s a death sentence,” Christi Turnage of Madison, Miss., said of the FDA’s decision. Her breast cancer had moved into her lungs before she began Avastin three years ago and the spreading stopped, but Turnage said her insurer is ending coverage and she will seek financial help from Genentech’s access program.
Hamburg said that she considered those arguments but that scientifically there are no clues yet to identify who those rare Avastin responders would be – putting a lot of people at risk in order for a few to get some as-yet-unknowable benefit. She urged Genentech to do that research, saying the FDA “absolutely” would reconsider if the company could find the right evidence.
Genentech, part of Swiss drugmaker Roche Group, pledged to begin that research.
“We are disappointed with the outcome,” said company chief medical officer Dr. Hal Barron. “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 in the United States.”
The breast cancer organization Susan G. Komen for the Cure said that it respected the FDA’s decision and that it was time for researchers to concentrate on finding so-called biomarkers that would tell which drug is right for which patient.
“Each type of cancer is very different from another in important ways, and in the end it‘s no surprise that Avastin’s effectiveness may not be equivalent against all types of cancer,” said Dr. Neal Meropol of University Hospitals Case Medical Center in Cleveland, who has long used Avastin for colon cancer.
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Comments (91)
Impenitent
Posted on November 18, 2011 at 10:33pmdeath panels? nope, not here…
Report Post »CobiusMaximus
Posted on November 18, 2011 at 11:16pmQ: if you could cure all the world’s diseases by killing a single innocent child, could you kill that child?
A. Are you kidding? I would kill all terminable cancer patients not to cure all diseases, but just to decrease the average person’s health insurance premiums by 96 cents per year. It is all for the greater good.
Let us look at this from a numbers perspective:
Each year, 40,000 are diagnosed with terminal breast cancer.
Prognosis is about 5 years.
That means that at any given time, there are about 200,000 terminal patients.
Median household income is $31,000.
If a terminal cancer patient were to work at half pace for half their remaining years, they would add $8k to GDP per person per year, a total of $1.6 billion per year; $8 billion over 5 year life.
Non-patients starting work on average at age 20, works, pays taxes, and pays for insurance for 45 years a 1:9 “living ratio” to patients.
LEAP IN MATH: So as long as non-patients save at least $2.96 in insurance premiums per year, we are financially justified in letting patients die.
That was a fun exercise of liberal thought. The mathematically-back rationale behind sacrificing human souls for the “general welfare”.
Report Post »CobiusMaximus
Posted on November 18, 2011 at 11:24pmAnd by liberal I mean Progessive.
Sun Tzu’s “Art of War”
If you know both yourself and your enemy, you will will 100% of the time.
If you know one but not the other, you will win 50% of the time.
If you know neither, you will win 0% of the time.
I suggest to not just dismiss these animals, but also to understand their ways of thinking. Only way to defeat them.
Report Post »sooner12
Posted on November 18, 2011 at 11:24pmThis is only the beginning of the “It would be best to just send them home with a little blue pill.” Obozo the idiot.
Report Post »encinom
Posted on November 18, 2011 at 11:39pmDid you read the article, the Drug has greater risks than benefits for breast cancer patients, it is still approved for the treatment of other cancers. You can remove a tumor with a shot gun blasts but the risks out way the rewards.
Report Post »JESUS-IS-LORD
Posted on November 19, 2011 at 12:15amNo man made pill could ever cure cancer.
Report Post »The-Monk
Posted on November 19, 2011 at 12:44amPlease read the book, “The Burzynski Breakthrough” by Thomas Elias, 2nd edition. I can’t understand how all these wealthy Hollywood people die from cancer when Burzynski has an 85% success rate with no side effects. It doesn’t even cost that much. $5K gets you in the door and starts your treatment. Anyone with cancer should go to Houston, Tx. and visit Dr. Stan Burzynski.
Report Post »No joke. Read the book. You will be surprised. Or go to your local Hospital from some slash and burn. It’s your choice. Read the book before you decide to do anything.
The-Monk
Posted on November 19, 2011 at 12:46am@JESUS-IS-LORD
Report Post »You sound like you read ACIM? Is that true?
Living In NYC
Posted on November 19, 2011 at 7:54amToo good of drug, too costly for Obamacare…revoke Avastin…enough said.
Get the government out of my body now!
Report Post »Moment of Clarity
Posted on November 19, 2011 at 12:27pmmay first thought too …
Report Post »spreadcommonsensenot pc
Posted on November 18, 2011 at 10:21pmThe BIGGEST stock holders in big pharma are “POLITICIANS” (ala insider trading)
Report Post »follow the money folks…………………..
Rweb
Posted on November 18, 2011 at 10:17pmThe real question is how many of these bums made million of this inside information.
Report Post »last frontier
Posted on November 18, 2011 at 10:04pmThey gave the money to Fisker to make a $89000 electric car in Finland besides these guys didn’t pony up any money for Obamas reelection stash.
Report Post »mharry860
Posted on November 18, 2011 at 10:17pmThat’s the first thing I thought when I heard this on the radio this morning.
Report Post »Totally Domestic
Posted on November 18, 2011 at 9:59pmAnother thing! I know an elder lady who has to get a B12 shot monthly due to anemia.
Report Post »It is a definite medical necessity. She goes to the Mayo Clinic to get the shot monthly.
She went to her monthly shot appt. and they told her that Mayo could not get B12 in.
She waited and waited weeks. At least 3. She was getting so weak I told her that she
must go to a walk in clinic or somewhere to get the shot. That is exactly what she did.
In apx another wk or 2 Mayo clinic called and said they had the B12 in.
Something is wrong when MAYO CLINIC CAN NOT GET B12!
SpeakUpNow
Posted on November 21, 2011 at 6:14amAs regards B12, I have been told by the pharmacist that the drug company will no longer be manufacturing this product and I don’t know where I will be able to get it in the future. Not sure exactly what is going on with this.
Report Post »Eblaze44
Posted on November 18, 2011 at 9:56pmNO, there are no “death panels”.
Report Post »22hornet
Posted on November 18, 2011 at 11:06pmNot yet but there will be…
Report Post »CatB
Posted on November 19, 2011 at 1:28amNo .. all they have to do is ban the “last resort” treatments and drugs.
TEA!
Obamacare SUCKS!
Report Post »algorp
Posted on November 19, 2011 at 1:09pmThere are no death panels, HA!
Report Post »They exist within medicare. You can only get healthy person exams every other year now.
Should you get some cancers, you may be too far advanced to be saved when your second year comes around.
Totally Domestic
Posted on November 18, 2011 at 9:50pmFirst the administration said, no need for yearly mammograms. Now, cancer patients can’t
Report Post »have the drug that prolong their lives. DEATH PANEL.
This isn’t the only useful drug that the FDA has taken off the market. Something is definitely
going on here.
Try getting Sudafed Sinus Headache med. Outlawed! Flimsy excuse that some people were
using this medication to make illegal drugs with. So, to H__ , with the people who have used it
for years to banish sinus headaches. Because, quite simply, it was the best med. on the market.
UncommonValor-CommonVirtue
Posted on November 18, 2011 at 10:16pmTD.. Excellent observations! I too have noted here recently that this admin and sympathetic arms have suddenly come forward to state that many yearly exams are over rated and really need to occur only every three years. Breast exams were first, then came along an exam for fellas, and recently another exam for women. Add to it this cancer drug is now going to be dropped for breast treatment. Already there are shortages being created in other treatment areas. And this is completely falling on the deaf ears of the MSM.
Report Post »jzs
Posted on November 18, 2011 at 10:18pmInsurance companies can still cover the drug. That’s their choice. The “government” hasn‘t said insurance companies can’t cover this drug or that doctors can’t prescribe it. The FDA evaluated survival rates for breast cancer and concluded that they don’t improve with this drug.
Okay, that’s what the FDA says, that’s what “the government says” but so what?
The “government”, the FDA, hasn’t banned this drug, nor have they told insurance companies they can’t prescribe it or doctors recommend it.
Insurance companies can still cover it if they want to. They’re your friends right? They aren’t interested in discontinuing coverage of this expensive treatment just because “the government” thinks the treatment is ineffective. They are interested in your survival even if it takes a little off of their bottom line right? That‘s what their commercials say and it’s illegal to have a commercials that aren’t true.
So they’ll continue pay for this drug. Why wouldn’t they? They can, they will. Because they are on our side, not the government’s side.
Report Post »louise
Posted on November 19, 2011 at 7:09amTotally Domestic, and Uncommonvalor: see my post on page 2
Report Post »Micmac
Posted on November 18, 2011 at 9:43pmThe 1st example of NoBamaCare at work.
NoBama 2012
Report Post »Reboot Washington
Xavier_Holden
Posted on November 18, 2011 at 9:38pmHow incredibly tragic.
No where to run. No where to hide. I am on the first alien craft off this planet.
Report Post »I.Gaspar
Posted on November 18, 2011 at 9:37pmThis is where we’re heading people…thanks, of course, to President Zero.
Report Post »They ought to consider changing the way his healthcare law is referred to.
It would be much more accurate to call it “Obamaflatoutdoesn’tcare”.
The death panels will be busy…but at least you won’t have to worry about not getting your social security…the government will make certain you’ll be dead before you get any social security.
1casawizard
Posted on November 18, 2011 at 9:45pmWe can move to Cuba, where they have the best health care in the world. Only 90 miles away.
Report Post »Coolcat51
Posted on November 18, 2011 at 9:34pmHas anyone read the book “The China Study”? Check it out if you think you have cancer.
Report Post »Brooke Lorren
Posted on November 19, 2011 at 12:46amThere’s a lot of disagreement about the China Study: http://www.cholesterol-and-health.com/China-Study.html
There’s also the book “World Without Cancer”: http://www.amazon.com/World-Without-Cancer-Story-Vitamin/dp/0912986190/ref=sr_1_1?ie=UTF8&qid=1321681532&sr=8-1
Report Post »whatthecrazy
Posted on November 18, 2011 at 9:30pmIm so sick of these people.Where are thier parents?They need to know what sorry little nasty disgusting evil little morons they raised.Labotomies for libs anyone?
Report Post »lukerw
Posted on November 18, 2011 at 9:39pmYou mean… like Bill Ayers & Joel Rogers… who Hate their Rich Parents?
Report Post »One Man Progressive Wrecking Crew
Posted on November 18, 2011 at 9:29pmCan you say “Death Panels”? I knew you could. :( The left had no idea what Palin meant when she coined these people this, this is the reason she did, and millions of others knew darn well what she meant..
They ARE in no uncertain terms federal death panels choosing who gets to live and who dies.
Report Post »pamela kay
Posted on November 19, 2011 at 1:21amPalin was right and that is exactly why they set out to destroy her. This is just the begining . When they came out agsinst the asthma inhalers I was concerned for the many people I know that need them. Including children. I have to wonder what is instore for those who need transplants. What about their anti-rejection meds? What about anti-depression, diabetic, or bloodpressure meds etc.? Will these meds be denied to those of us that need them? What about premie babies? So our lives will be in the hands of a panel of progressive robots.? It is coming, they want population control, what better way to eliminate those who do not contribute to society by their standards? If they knock out the elderly, the sick, and the physically handicapped they can keep all of the social security that is paid in. Problem solved.
Report Post »dwh320
Posted on November 18, 2011 at 9:27pmThis is just a example of Obama-Non-Care at work. Through “regulations” they will change health care by denying care.
Report Post »Eliasim
Posted on November 18, 2011 at 9:37pmStill blind I see. It should be: through regulation they will lower population by denying health care, and simultaneously redistribute wealth.
Report Post »cassandra
Posted on November 18, 2011 at 9:23pmcan you say Agenda 21
Report Post »randy
Posted on November 18, 2011 at 9:22pmAnd so the Death Panels start.
Report Post »How do you like that Progressives?
Eliasim
Posted on November 18, 2011 at 9:27pmI think Progressives like it a lot.
Report Post »NOBALONEY
Posted on November 18, 2011 at 9:18pmFDA & Obamacare: Who needs Death Panels? We just revoke meds, and end long term care, and wait for the results.
Report Post »progressiveslayer
Posted on November 18, 2011 at 9:23pmThat‘s how they’re going to do it.
Report Post »georgiavietvet
Posted on November 18, 2011 at 9:17pmcan we all say medical rationing? this is just the first step…………………………….
Report Post »jchristnumber2
Posted on November 18, 2011 at 9:17pmIf people would pray with all their hearts they would not get cancer in the first place.
Report Post »Eliasim
Posted on November 18, 2011 at 9:24pmDo you know why it says in the Bible that the elects suffering will be shortened? Because when someone is truly spiritual they don’t mind leaving, because they know at some point in the future they will be back again.
Report Post »dontbotherme
Posted on November 18, 2011 at 11:20pmjchristnumber2 – What the h_ll is wrong with you? What do you pray for? Is there any illness anywhere in your family? Did they become ill because their prayer life was inadequate?
Report Post »progressiveslayer
Posted on November 18, 2011 at 9:16pmThese idiots that want socialized medicine have no clue what’s going to happen,rationing to begin with
and rejection of claims will be astronomical.They think private insurers reject claims wait until government gets their greedy hand in there,they‘ll show those insurance companies how it’s done.
When government controls your health care they control you completely.
Report Post »Eliasim
Posted on November 18, 2011 at 9:21pmYou still haven’t gotten it through your head yet that they are not idiots have you?
Report Post »sissykatz
Posted on November 18, 2011 at 9:22pmI don’t want the Government any where near my Doctor or
Report Post »my treatment. Get out of our Health Care. Amazing…..
I want my treatments to be by My Dr. not some Government entitiy.
Eliasim
Posted on November 18, 2011 at 9:22pmOr at least the puppet masters are not idiots.
Report Post »progressiveslayer
Posted on November 18, 2011 at 9:31pmI was referring to the general public that eats the BS they’re fed not Soros and his ilk.
Report Post »Snowleopard {gallery of cat folks}
Posted on November 18, 2011 at 9:15pmOnce again we see the results in action of the Obama death machinery of Obama-care.
Report Post »Psychosis
Posted on November 18, 2011 at 9:12pmi have a better idea
dismantle ALL federal programs
let the states run programs if they so desire , and keep the money state side
fire ALL fed regulators …………..they either are a complete waste of money, counter-intuitive, or complete failures
also, i think congress should only meet for 2 months of the yr , and spend the rest of the time in their home districts ……………also they should not get payed more than our servicemen
cut all politicians pay to the same as a 4 yr service menber
Report Post »1casawizard
Posted on November 18, 2011 at 9:40pmAre you forgetting term limits for elected offices? I’m not including alot of others but you do have a good start. Remember WE or TEA have to win this round.
Report Post »YoungBloodNews
Posted on November 18, 2011 at 9:12pmStopped reading after chemo was mentioned. Chemo is bad stuff, studies came out recently showing it highly damages the brain….
Report Post »progressiveslayer
Posted on November 18, 2011 at 9:18pmSo that’s what happened to Pelosi,Biden and Reid.
Report Post »SheriS
Posted on November 18, 2011 at 9:20pmChemo also extends the life and saves lives as well! I have friends who have survived cancer thanks to Chemo and have lived very useful lives thanks to the Chemo! But I guess that will end thanks to the rat in the White House! Many have survived for years and lived normal lives!
Report Post »Eliasim
Posted on November 18, 2011 at 9:10pmI wonder if Americans will ever reach the point of figuring out that the government wants them to die-off in a controlled manner?
Report Post »Eliasim
Posted on November 18, 2011 at 9:16pmIf they don’t know then it must be that they truly are beasts because even some dogs know when the shelter has them lined up to be put down.
Report Post »lukerw
Posted on November 18, 2011 at 9:10pmGet the Feds out of my Doctor’s Office and Pharmacy!
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