The Death Panel's First Murder

Good question.

All the FDA should be doing is to determine if the drug is safe.

Effectiveness should be up to the doctor and the patient.
 
Good question.

All the FDA should be doing is to determine if the drug is safe.

Effectiveness should be up to the doctor and the patient.

They determined that it is not safe.

Avastin is NOT a safe medication. The side-effects are deadly.

That's where studies showing risk/benefit are important.
 
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Suspicious findings by a corrupt and compromised bureaucracy, especially given that the subjects are people with advanced cancer.
 
Good question.

All the FDA should be doing is to determine if the drug is safe.

Effectiveness should be up to the doctor and the patient.

They determined that it is not safe.

Avastin is NOT a safe medication. The side-effects are deadly.

That's where studies showing risk/benefit are important.

Side effects are more deadly then terminal cancer?

Oh!!! I forgot. Its a beaurocrats job to protect you from yourself!

Wasn't it the FDA that said women under 40 or something should not get a breast exam? Maybe it was another federal agency. That went over real good with women and doctors:cuckoo:
 
Suspicious findings by a corrupt and compromised bureaucracy, especially given that the subjects are people with advanced cancer.

Suspicious findings by a corrupt and compromised bureaucracy?

How about a study performed by the manufacturer (E2100) which showed promising results thus allowing the medication to receive accelerated approval, but then required confirmatory trials (AVADO and RIBBON1) which did not show the same promising results?

http://www.fda.gov/downloads/Drugs/...ormationforPatientsandProviders/UCM237171.pdf

The FDA does not perform any studies. They are given the results from independent investigators (which are usually funded by the phamaceutical company), and they make a determination as to the safety and efficacy of the med based on the studies.
 
Good question.

All the FDA should be doing is to determine if the drug is safe.

Effectiveness should be up to the doctor and the patient.

They determined that it is not safe.

Avastin is NOT a safe medication. The side-effects are deadly.

That's where studies showing risk/benefit are important.

Side effects are more deadly then terminal cancer?

Oh!!! I forgot. Its a beaurocrats job to protect you from yourself!

Wasn't it the FDA that said women under 40 or something should not get a breast exam? Maybe it was another federal agency. That went over real good with women and doctors:cuckoo:

The FDA's job is to prevent medications from being marketed inappropriately...for Genentech from saying "With Avastin, your breast cancer can be cured!".

The FDA does not prevent a patient from using the med, as long as the patient realizes that the Avastin will be as about as effective at curing their cancer as a tall glass of ice water.
 
Why is it then I always hear about the FDA "pulling the medication off the market"

I always hear about medications in other countries but not here because the FDA hasn't "approved" it yet.

Unless I was hearing voices, that sounds like the FDA has the power to tell you what you can and can not put into your body.

I'm not defending the drug in question. It may very well be inneffective. But if it gives someone hope of living a few months longer than why does it matter? Unless the government is paying for it, then it does matter.

Oh yeah! I forgot!!! There will be no rationing of health care. I trust all those politicians and beauracrats that wrote those papers on how to ration health care, when they say they won't ration health care. :cuckoo:
 
Avastin does work on breast cancer, this is all about cost, you can choose to believe the idiots on this board that it doesn't, my 73 year old assistant has been on it since 3/2/10, her second round of breast cancer in 11 years, most of the tumors are gone, the few that remain are 5% of their original size, she has not missed a day of work since treatment began.....

Here is a women who has paid her Medicare requirements and you're to stupid to see the truth, your mighty brave on this message board, sad that after 10 months the drug that has kept her alive, someone in DC believes it is not doing the job, do you still think the government should run healthcare.....
 
Avastin does work on breast cancer, this is all about cost, you can choose to believe the idiots on this board that it doesn't...

If it is all about cost, then prove it.

Show the statement or finding by the FDA that says "Due to the excessive cost of this medication, we are removing the approval of Avastin for breast cancer."

I will be waiting.

...my 73 year old assistant has been on it since 3/2/10, her second round of breast cancer in 11 years, most of the tumors are gone, the few that remain are 5% of their original size, she has not missed a day of work since treatment began.....

I am happy for your assistant.

Unfortunately, in medicine, recommendations for treatment are not based on anecdotes.

I'm sure that there is a woman somewhere in the world has had her tumors shrunk by flicking and tweaking her nipples. But it doesn't work for everyone, and therefore it would not become an official recommendation.
 
I bet LK has no problem with his health care.
I bet it is nice living in germany and not having to worry about getting sick. Right now if I get sick and have to go to the doctor, I would be screwed.

I've been to both Canada and Germany and in both countries evey one I've spoke to about their healthcare systems have said they would rather have theirs than ours.

Bet you didn't talk to any rich people. They like ours because they can pay and get what they want, when the want. The rest of us go without. At least in those countries the rest of us have a chance at getting treatment. Here what do we have?
 
Suspicious findings by a corrupt and compromised bureaucracy, especially given that the subjects are people with advanced cancer.

Those darn elitists scientists and doctors. What do they know with all that "research" and "study". The fuckers. Everyone knows the most effective treatment for any disease is to pray over "camel dung", stir it together with road apples, steam it in chicken soup, hop and one foot and sing the "Rainbow" song. Now THAT'S real science! That will cure anything.
 
Avastin does work on breast cancer, this is all about cost, you can choose to believe the idiots on this board that it doesn't...

If it is all about cost, then prove it.

Show the statement or finding by the FDA that says "Due to the excessive cost of this medication, we are removing the approval of Avastin for breast cancer."

I will be waiting.

...my 73 year old assistant has been on it since 3/2/10, her second round of breast cancer in 11 years, most of the tumors are gone, the few that remain are 5% of their original size, she has not missed a day of work since treatment began.....

I am happy for your assistant.

Unfortunately, in medicine, recommendations for treatment are not based on anecdotes.

I'm sure that there is a woman somewhere in the world has had her tumors shrunk by flicking and tweaking her nipples. But it doesn't work for everyone, and therefore it would not become an official recommendation.

How did I know you would be the idiot to make such a comment....

My first reaction & action to your asinine comment of flicking or tweaking her nipples would not be a good one for you, do you get my meaning little one???

So you think you know more than her oncologist? Are you serious or just that arrogant?

“I’m sure it will be used off-label,” says Francisco J. Esteva, MD, PhD, a professor in the breast medical oncology department and the director of the Breast Cancer Translational Research Laboratory at the University of Texas M.D. Anderson Cancer Center in Houston. “If a patient is being treated with Avastin and paclitaxel and is responding and doing well, I would continue its use,” he says.

Meaning insurance will not have to COVER IT, that would put some clarity on the cost issue, not a complete indictment, just puts the cost issue into better focus.....

"Joseph Sparano, MD, a medical oncologist at Montefiore-Einstein Center for Cancer Care in the Bronx, N.Y., says that he “fundamentally disagrees with FDA assessment of the benefit risk ratio of Avastin for use in breast cancer treatment.” Sparano has served as a paid speaker and consultant to Genentech on Avastin."

He says that the main issue now will be an economic one.

“This is a very useful drug and it doubles the response rate to chemotherapy and the time that disease is under control,” he says. “At one year, more patients are alive, which means it is effective and safe,” Sparano tells WebMD.

“This is a sad day for our patients because they will have one less effective option, and what makes it even sadder is that this drug is still available and its use will be based on who can pay for it rather than who can benefit from it,” he says.

Insurers will likely not cover the off-label use of the drug. The wholesale price of Avastin (minus infusion costs) is around $7,500 a month. “This certainly will become a barrier for many patients,” Sparano says.


Granted he has served as a paid spokesperson and consultant, but this statement could not speak more to the truth "its use will be based on who can pay for it rather than who can benefit from it, " he says.

Maurie Markman, MD, vice president of patient oncology services and the national director of medical oncology at Cancer Treatment Centers of America in Philadelphia, is also disheartened by this turn of regulatory events.

“This is a most unfortunate decision by the FDA and potentially deprives women with breast cancer use of an anti-cancer agent that has unequivocally been demonstrated to prolong time to disease progression in multiple evidence-based randomized phase 3 trials conducted by outstanding research organizations,” Markman writes in an email.

“Cancer care is highly personalized and individualized [and] the decision of whether this drug should be used in management of individual patients should be determined between her and her healthcare team,” he writes.

Markman has served as a member of a medical advisory board for Genentech on ovarian cancer.


Yet another testament to its effectiveness....

I would bet if your balls where flicked and tweaked every time you made such a callous statement you would learn to keep your stupid opinions to yourself, that is if you have any.....

And here is the final irony to this.....

"The European Union's version of the FDA, the European Medicines Agency (EMA), also came down on Avastin’s use in breast cancer, but did not go as far as the FDA. An EMA regulatory panel stated that Avastin should not be used with the chemotherapy docetaxel (Taxotere), but it can still be used with paclitaxel."

The EU decides to continue its use under the same application it has been found to be effective in the US.....

So tell us again, what is it you do???
 

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