FDA revokes approval of Avastin for breast cancer

[red states rule]

Has the rationing started? A drug that save lives but costs to much - have to cut costs somewhere - so cut the meds

Looks like Sarah Palin has been proven right again




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.


http://www.businessweek.com/ap/financialnews/D9R3HU3O2.htm


[/QUOTE]

[Psychoblues]

Here we go again, rsr. I've already beat you down and beat you down so badly you tried to change the subject repeatedly but I wouldn't let you and ultimately you abandoned the thread on this exact subject. The FDA is not leaving patients in want or need of any drug that demonstrates usefulness and success in treating diseases for cost or for any other reason. The FDA still recognizes Avastin as a good drug for other illnesses and diseases. But please consider this. The FDA doesn't write prescriptions nor does it treat patients. If you have breast cancer and you can't wait to get your $2000 per dose Avastin and you can talk your doctor into prescribing it for you then you can use it to treat your hemorrhoids if you want. But, don't say that the FDA hasn't warned you already that it is ineffective and serves no good purpose for treating certain types of breast cancer.

Psychoblues

[red states rule]

Here we go again, rsr. I've already beat you down and beat you down so badly you tried to change the subject repeatedly but I wouldn't let you and ultimately you abandoned the thread on this exact subject. The FDA is not leaving patients in want or need of any drug that demonstrates usefulness and success in treating diseases for cost or for any other reason. The FDA still recognizes Avastin as a good drug for other illnesses and diseases. But please consider this. The FDA doesn't write prescriptions nor does it treat patients. If you have breast cancer and you can't wait to get your $2000 per dose Avastin and you can talk your doctor into prescribing it for you then you can use it to treat your hemorrhoids if you want. But, don't say that the FDA hasn't warned you already that it is ineffective and serves no good purpose for treating certain types of breast cancer.

Psychoblues


More spin from our resident liberal. It must really bug you to watch what was said was going to happen - actaully happen. Rationed care was the goal of Obmacare. Even libs can;t spend the money that Obamacare will actually cost

So the only option - cut expenses. Reduce the level of care ans if people die - it is for the common good

[Psychoblues]

More spin from our resident liberal. It must really bug you to watch what was said was going to happen - actaully happen. Rationed care was the goal of Obmacare. Even libs can;t spend the money that Obamacare will actually cost

So the only option - cut expenses. Reduce the level of care ans if people die - it is for the common good

Care is not being rationed by the FDA at all, rsr. Demonstrate that it is and I will accept that and apologize. This fearmongering, however, needs to stop. Avastin is worthless as a medical tool in certain types of breast cancer but it remains available for whatever reason your doctor may want to prescribe it. Why does that concept escape you so, rsr? That it is ineffective in certain cases is demonstrable and real. It must really pain you that the rationing that so many of you rightwingers delude yourselves about is not happening. By the way. Rationing in healthcare has been going on for at least since the advent of HMO's and PPO's and to one degree or another since I was born in 1950.

Psychoblues

[red states rule]

Care is not being rationed by the FDA at all, rsr. Demonstrate that it is and I will accept that and apologize. This fearmongering, however, needs to stop. Avastin is worthless as a medical tool in certain types of breast cancer but it remains available for whatever reason your doctor may want to prescribe it. Why does that concept escape you so, rsr? That it is ineffective in certain cases is demonstrable and real. It must really pain you that the rationing that so many of you rightwingers delude yourselves about is not happening. By the way. Rationing in healthcare has been going on for at least since the advent of HMO's and PPO's and to one degree or another since I was born in 1950.

Psychoblues

The now the drungs needed to keep someone alive is not considered "care"

Damn PB you would be perfect to work for the staff of claim processors for Obamacare

Stocks for coffin makers would skyrocket.

First the bill is rammed thru, then the cost of coverage goes up, fewer employers offering the benefit, and now the government starts rationing care

Everything that was said was going to happen if Obamacare was passed is happeneing

No wonder a majority of voters want Obamacre repealed

[Psychoblues]

Please demonstrate even in a superficial way how the FDA is rationing anything. Please demonstrate even in a superficial way how the FDA might be incorrect in the assessment of Avastin for the diseases it says the drug is ineffective. Although the FDA is responsibly aware of costs and budgets, please demonstrate in even a superficial way how that has cost the health or life of a single patient. And please, even in any superficial way demonstrate how the FDA is preventing anyone from receiving Avastin for any reason their doctors are prescribing it.

Or, is your fearmongering and delusions all you have to offer?

Psychoblues

[darin]

stories like this re-enforce to me the FDA should be disbanded. :( Tragedy. They revoke things like this NOT to protect anyone, but for political reasons. Lame

[logroller]

stories like this re-enforce to me the FDA should be disbanded. :( Tragedy. They revoke things like this NOT to protect anyone, but for political reasons. Lame

If anything it was approved for breast cancer treatment for political reasons, not the other way around. As i understand it, Avastin has been shown to work on other forms of cancer, and an initial study (conducted by Genentech, as subsidiary of Roche) showed it could help with breast cancer. Instead of waiting for more concrete data, the FDA approved its use for BC, pending future study-- To which other studies showed no benefits, only side-effects-- so the approval was revoked. Interestingly, Medicare still covers it; so I don't see how politics or even costs were of consideration in it being revoked, just science.

[Psychoblues]

If anything it was approved for breast cancer treatment for political reasons, not the other way around. As i understand it, Avastin has been shown to work on other forms of cancer, and an initial study (conducted by Genentech, as subsidiary of Roche) showed it could help with breast cancer. Instead of waiting for more concrete data, the FDA approved its use for BC, pending future study-- To which other studies showed no benefits, only side-effects-- so the approval was revoked. Interestingly, Medicare still covers it; so I don't see how politics or even costs were of consideration in it being revoked, just science.

Exactly, lr, and like you I find it interesting that Medicare and thusly Medicaid continue to approve it for the FDA non-approved uses. That and the fact that FDA doesn't pay for any drugs and Medicare and Medicaid do pay for drugs is my primary concern. These are things that deserve our attention.

Psychoblues

[trobinett]

stories like this re-enforce to me the FDA should be disbanded. :( Tragedy. They revoke things like this NOT to protect anyone, but for political reasons. Lame

Seems to me, there is NO part of our lives that isn't influenced by political concerns.

[red states rule]

Please demonstrate even in a superficial way how the FDA is rationing anything. Please demonstrate even in a superficial way how the FDA might be incorrect in the assessment of Avastin for the diseases it says the drug is ineffective. Although the FDA is responsibly aware of costs and budgets, please demonstrate in even a superficial way how that has cost the health or life of a single patient. And please, even in any superficial way demonstrate how the FDA is preventing anyone from receiving Avastin for any reason their doctors are prescribing it.

Or, is your fearmongering and delusions all you have to offer?

Psychoblues

Please keep ignoring the results of Obamacare and government interference with the private secotr

I also know damn weel you will iognore any news stories of people dying due to the governemnt rationing of healthcare - and if you do - you will blame Bush and the R's for it

[DragonStryk72]

Please keep ignoring the results of Obamacare and government interference with the private secotr

I also know damn weel you will iognore any news stories of people dying due to the governemnt rationing of healthcare - and if you do - you will blame Bush and the R's for it

Then prove him wrong for the rest of us.

[red states rule]

Then prove him wrong for the rest of us.

In your case (and PB"S) is it easy

From the above link




"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 argument

s 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.

http://www.businessweek.com/ap/financialnews/D9R3HU3O2.htm

[DragonStryk72]

In your case (and PB"S) is it easy

From the above link

From the above link:


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

Now, if you have any actual proof, which I know you don't, then show it. Otherwise, the above link from the OP is already proof against you. It's not a cure for Breast Cancer. The lady's subjective description is not proof of anything. Of course she's going to feel like it was miracle drug, but the rigorous testing described in your article has proven that it does not actually work on breast cancer, and does not provide any other significant benefits. Again, it hasn't been taken off the market, it's just not advised to prescribe it for breast cancer, since it, again doesn't actually work, apparently. Unless you can prove us, it's pretty much a done deal.

As for the "politics" of the drug being allowed in the first place, it actually does work on colon cancer, just not breast cancer, apparently. What most likely occurred was that doctors started trying it out on their breast cancer patients since they had seen success in other forms of cancer. It ends up that it didn't work in this case, so the FDA basically did it's job, leaving the drug on the market while removing its endorsement from the arenas it doesn't work in.

[Psychoblues]

From the above link:



Now, if you have any actual proof, which I know you don't, then show it. Otherwise, the above link from the OP is already proof against you. It's not a cure for Breast Cancer. The lady's subjective description is not proof of anything. Of course she's going to feel like it was miracle drug, but the rigorous testing described in your article has proven that it does not actually work on breast cancer, and does not provide any other significant benefits. Again, it hasn't been taken off the market, it's just not advised to prescribe it for breast cancer, since it, again doesn't actually work, apparently. Unless you can prove us, it's pretty much a done deal.

As for the "politics" of the drug being allowed in the first place, it actually does work on colon cancer, just not breast cancer, apparently. What most likely occurred was that doctors started trying it out on their breast cancer patients since they had seen success in other forms of cancer. It ends up that it didn't work in this case, so the FDA basically did it's job, leaving the drug on the market while removing its endorsement from the arenas it doesn't work in.

I spent days, maybe a week or so once before on this identical subject with rsr. Even though I could produce the facts and get them from a number of sources and described in a number of different ways, rsr continued his diatribes against the facts all the while calling me an idiot, a troll, hard-headed and worse and he never produced a single fact to back up his claims. You might notice that rsr has plenty of threads that he starts for which there are no replies other than possibly his answering himself. That is normally because his sources and claims are so flawed and outrageous no one in their right mind would enter those very troubled waters. Every now and again I see one like this and find it simply hilarious how he maintains his emperor with no clothes attitude. I don't think he really understands that so many are laughing at him and not with him.

:laugh2::laugh2::laugh2:

Psychoblues

[darin]

If anything it was approved for breast cancer treatment for political reasons, not the other way around. As i understand it, Avastin has been shown to work on other forms of cancer, and an initial study (conducted by Genentech, as subsidiary of Roche) showed it could help with breast cancer. Instead of waiting for more concrete data, the FDA approved its use for BC, pending future study-- To which other studies showed no benefits, only side-effects-- so the approval was revoked. Interestingly, Medicare still covers it; so I don't see how politics or even costs were of consideration in it being revoked, just science.

How many people were counting on the drug? How many did it help? Studies generally rely upon 'averages'. The 'average' almost never happens. The gov't should let patients and doctors decide.

I agree with Stossel.


http://www.youtube.com/watch?v=yGbB3ZVcYIM

[Psychoblues]

How many people were counting on the drug? How many did it help? Studies generally rely upon 'averages'. The 'average' almost never happens. The gov't should let patients and doctors decide.

I agree with Stossel.


http://www.youtube.com/watch?v=yGbB3ZVcYIM

Looks to me like Bill O'Reilly is advocating the reasonable position here while John Stossel is pushing unlimited access to oxycontin and any other drugs that a "consenting adult" might desire for whatever reason they might want them and doctors, or FDA or any government studies or suggestions be damned. Must be tough living in his skin. Avastin was never mentioned in the video and the FDA has concluded that Avastin doesn't help ANYONE with certain types of breast cancer. I find no mention whatsoever of any "averages". I betcha others have concluded the same thing.

Psychoblues

[sundaydriver]

I worked for for Roche for 23 years in research and wished it worked also. Wishing unfortunatly dos not make it so.

The commissioner, Dr. Margaret A. Hamburg (http://topics.nytimes.com/top/reference/timestopics/people/h/margaret_a_hamburg/index.html?inline=nyt-per), said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors (http://health.nytimes.com/health/guides/disease/tumor/overview.html?inline=nyt-classifier), but did expose them to potentially serious side effects like severe high blood pressure (http://health.nytimes.com/health/guides/disease/hypertension/overview.html?inline=nyt-classifier) and hemorrhaging.
"Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing," Dr. Hamburg told reporters Friday. "This is the case with Avastin when used for the treatment of metastatic breast cancer."



It is the right decision for women and for science," Frances M. Visco, president of the National Breast Cancer Coalition (http://www.breastcancerdeadline2020.org/?__utma=1.1966596640.1321655443.1321655443.1321655 443.1&__utmb=1.6.10.1321655443&__utmc=1&__utmx=-&__utmz=1.1321655443.1.1.utmcsr=en.wikipedia.org|ut mccn=%28referral%29|utmcmd=referral|utmcct=/wiki/National_Breast_Cancer_Coalition&__utmv=-&__utmk=27440188), said in an e-mail. "We all wished the drug worked. It does not."


http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html (http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html)

[Psychoblues]

I worked for for Roche for 23 years in research and wished it worked also. Wishing unfortunatly dos not make it so.

The commissioner, Dr. Margaret A. Hamburg (http://topics.nytimes.com/top/reference/timestopics/people/h/margaret_a_hamburg/index.html?inline=nyt-per), said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors (http://health.nytimes.com/health/guides/disease/tumor/overview.html?inline=nyt-classifier), but did expose them to potentially serious side effects like severe high blood pressure (http://health.nytimes.com/health/guides/disease/hypertension/overview.html?inline=nyt-classifier) and hemorrhaging.
"Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing," Dr. Hamburg told reporters Friday. "This is the case with Avastin when used for the treatment of metastatic breast cancer."



It is the right decision for women and for science," Frances M. Visco, president of the National Breast Cancer Coalition (http://www.breastcancerdeadline2020.org/?__utma=1.1966596640.1321655443.1321655443.1321655 443.1&__utmb=1.6.10.1321655443&__utmc=1&__utmx=-&__utmz=1.1321655443.1.1.utmcsr=en.wikipedia.org%7C utmccn=%28referral%29%7Cutmcmd=referral%7Cutmcct=/wiki/National_Breast_Cancer_Coalition&__utmv=-&__utmk=27440188), said in an e-mail. "We all wished the drug worked. It does not."


http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html (http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html)

Thanks for your work with Roche and your knowledge of this subject.

Psychoblues