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An FDA Panel Is Deciding Life or Death For My Wife
Fox News ^ | 6/28/11 | Terry Kalley

Posted on 06/28/2011 1:59:51 PM PDT by markomalley

December 16, 2010 will forever be the day that changed my life. I had just received a news flash across my monitor that the FDA had confirmed its advisory panel’s decision to ”de-label” the drug Avastin for breast cancer patients. The practical implication of this was that my wife Arlene was now at mortal risk.

My wife has stage IV or metastatic breast cancer. This is an incurable disease that claims the life of a woman every 14 minutes. A reported 17,500 women take Avastin for metastatic breast cancer and my wife is one of them. As Avastin is a unique drug that works by cutting off blood flow to tumors, we believe that the drug is saving my wife’s life and taking Avastin away is tantamount to a death sentence.

I picked up the phone to call my wife and tell her the news. When she answered, I was too choked-up to speak. The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.

I read a mountain of reports about the FDA’s Avastin decision and it become clear that it was corrupted with procedural problems (the Wall St. Journal referred to it as “rigged”), rendered almost meaningless by poor science and tainted by the bad faith of the FDA, which had moved the goalposts for approval of Avastin, almost after the game had been played.

The drug’s manufacturer, Genentech, said that it would file an appeal and the FDA granted a hearing for June 28 and 29 in Silver Spring, Maryland.

(Excerpt) Read more at foxnews.com ...


TOPICS: Editorial; Government
KEYWORDS: deathpanels; moralabsolutes; prolife
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A heart-rending story that will become more and more common as Obamacare phases in over the next few years.
1 posted on 06/28/2011 1:59:54 PM PDT by markomalley
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To: markomalley

If this Avastin was available on the free market, no prescription
or “titled” medical person needed in the loop, would folks pay for it?

I’ve often wondered why the arrogant medical profession needs to
place itself between people and cures.. other than to make bucks.


2 posted on 06/28/2011 2:05:43 PM PDT by humblegunner
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To: markomalley

It costs more to keep people alive with the proper meds than to take the mes away so they die quicker. Breast cancer treatment today, what will it be tomorrow? And we thought China was evil killing baby girls.
Welcome to the new Amerika.


3 posted on 06/28/2011 2:05:57 PM PDT by bgill
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To: humblegunner

Very good point, with the caveat that not many drugs can be administered DIY.


4 posted on 06/28/2011 2:10:29 PM PDT by Amberdawn
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To: humblegunner

I would suggest that one of the reasons prescription drugs are so expensive is the frequent unnecessary delays in approval by the FDA.


5 posted on 06/28/2011 2:11:16 PM PDT by rusty millet
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To: markomalley

I hate this MF’er SOB!

This stuff scares me! So “Soilent Green” like


6 posted on 06/28/2011 2:11:22 PM PDT by alice_in_bubbaland (DeMint /Palin, DeMint/Bachmann, DeMint/Cain, DeMint/Ryan 2012!!!!!!!)
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To: markomalley

is this drug available in canada? if so, a short trip to a canadian doctor and a prescription are in order


7 posted on 06/28/2011 2:13:04 PM PDT by joe fonebone (Project Gunwalker, this will make watergate look like the warm up band......)
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To: bgill
Avastin was thought to be useful in breast cancer. At the same time it was not thought to be useful in uterine cancer.

Even with studies in hand showing it's utility you couldn't get access to it for uterine cancer.

Then one day "they" decided it was OK for that kind of cancer, but shortly thereafter began withdrawing their approval of it for breast cancer.

People close to us were part of that story ~ but in the end Avastin is NOT and cannot be a cure. Patients' cancer cells develop a sort of resistance to it.

At best these drugs just stave off the end.

I'd like to note for you these are not casual drugs to just pop in your mouth and wash down with water.

8 posted on 06/28/2011 2:13:22 PM PDT by muawiyah
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To: markomalley

Of course, the drug Avastin will always be available to Obama, congresscritters and SCOTUS members. That’s why you don’t hear any protest from them.


9 posted on 06/28/2011 2:13:32 PM PDT by 353FMG
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To: markomalley

bttt


10 posted on 06/28/2011 2:13:45 PM PDT by tutstar
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To: humblegunner
http://www.avastin.com/avastin/hcp/lung/dosing/index.html Take a look at how this drug is administered ~ it's by "infusion" which means a needle/tube hookup in the arm, then it's pumped in there slowly under close supervision by a RN in a qualified cancer therapy medical facility.

I thought it was interesting that they have a problem with 1% to 3% of patients ~ per infusion.

What that means is it slops out somehow and gets pumped into your muscle tissues.

This is always bad.

You can get the drug on the open market ~ all that happened here is that it was no longer qualified for automatic Medicare (or other government) payment. People with private insurance could get it.

ObamaKKKare provides that you won't "get it" when it takes over everything including private insurance plans.

11 posted on 06/28/2011 2:20:06 PM PDT by muawiyah
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To: markomalley

“The FDA should never have approved Avastin for breast cancer to begin with,” said Fran Visco of the National Breast Cancer Coalition. “We don’t see evidence of benefit, but we do see evidence of harm.”

http://www.washingtonpost.com/wp-dyn/content/article/2010/08/15/AR2010081503466.html


12 posted on 06/28/2011 2:21:49 PM PDT by Raycpa
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To: markomalley

It’s likely he can find it in Mexico, India or China.


13 posted on 06/28/2011 2:31:41 PM PDT by Mariner (War Criminal #18)
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To: markomalley

It is heart rending. However, peoples reaction to the FDA’s action is the direct result of the fact that those in government so live and love to lie that they have lost all credibility. Those who have been allowed to sit in places of authority are financially and morally bankrupt. No one believes them. They have ruined our country and the only question remaining is whether America can recover.


14 posted on 06/28/2011 2:32:27 PM PDT by AEMILIUS PAULUS (It is a shame that when these people give a riot)
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To: humblegunner

What does the medical profession have to do with making it a prescription drug?

That would be the FDA that makes it hard for you to get what you want and what makes drug so expensive.

I am one of those arrogant medical professionals who helped to develop treatments for diseases and vaccines and who also happens to have MS.

If you are so smart. You dedicate your life to the development of cures and treatments, and then get back to me.


15 posted on 06/28/2011 2:53:03 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: markomalley

Bump!


16 posted on 06/28/2011 3:14:32 PM PDT by Mr. Silverback (Anyone who says we need illegals to do the jobs Americans won't do has never watched "Dirty Jobs.")
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To: markomalley

Does this fall under the Moral Absolutes or Pro-Life catagories?


17 posted on 06/28/2011 3:14:50 PM PDT by Clintonfatigued (Illegal aliens collect welfare checks that Americans won't collect)
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To: HonestConservative

“I am one of those arrogant medical professionals who helped to develop treatments for diseases and vaccines and who also happens to have MS.”

Avastin is also a drug that the FDA will not approve for wet macular degeneration—a disease which will eventually cause vision loss and which I happen to have. It can’t cure it, but can stop or slow down the progression of the disease. It’s cost would be $150-$200 per injection vs the FDA “approved” drug Lucentis which is about $2000/inj. Who’s pocket is the money getting into? Oh—one needs to have those injections frequently by the way.


18 posted on 06/28/2011 3:27:16 PM PDT by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel
So, where do you get your injections or infusions? In a special facility, a doctor's office, where?

That can make a whopping difference in the cost of any sort of medicine that requires special handling.

BTW, you may have missed it ~ fortunately you can enlarge the type on your computer so you'll be with us for many years ~ "they" are getting closer and closer to both electronic and biological replacements for the macula.

I can appreciate that myself.

Do we have a "blind guys" caucus list? We need it.

19 posted on 06/28/2011 3:34:43 PM PDT by muawiyah
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To: muawiyah

“So, where do you get your injections or infusions? In a special facility, a doctor’s office, where?”

Retinal specialist. Let me know of any updates on the “macula replacements”


20 posted on 06/28/2011 3:37:57 PM PDT by freeangel ( (free speech is only good until someone else doesn't like it)
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