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FDA revokes Avastinís approval for breast cancer treatment
Washington Post ^ | November†18, 2011 | Rob Stein

Posted on 11/18/2011 11:14:44 AM PST by Qbert

The Obama administration Friday revoked the approval of the best-selling drug Avastin for treating advanced breast cancer in the United States, despite appeals from distraught women, some patients advocates and the company that makes the drug.

FDA Administrator Margaret Hamburg issued a 69-page decision outlining her decision, which was based on the recommendation of a six-member FDA advisory committee that unanimously concluded in June that the drug was harming women more than it was helping them.

[Snip]

... Genentech spokesman Charlotte Arnold.

“We are disappointed with this outcome. 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,” she said.

The decision was condemned by some patient advocacy groups.

“By not recognizing the fact that a subgroup of women with metastatic breast cancer respond well to Avastin, we have yet another tragic mistake by the FDA,” said Frank Boroughs of the Abigail Alliance, which advocates for greater access to new treatments. “Because of FDA drug rejections like Avastin for breast cancer, the terribly slow FDA approval of lifesaving therapies, and the FDA’s blocking of compassionate access, we are losing thousands of lives of cancer patients and others with serious life threatening illnesses each year.”

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


TOPICS: Government; Miscellaneous; News/Current Events
KEYWORDS: avastin; cancer; deathpanels; lifehate; obamacare; overpopulation; rationing
Now, if it were made by an Obama donor's bankrupt company, it would be a different story...
1 posted on 11/18/2011 11:14:47 AM PST by Qbert
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To: Qbert

Kinda’ wonder when they’re gonna’ stop all abortions because they contribute to increase in breast cancer. . . . .


2 posted on 11/18/2011 11:17:30 AM PST by laweeks
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To: laweeks

Not to mention what it does to the babies.


3 posted on 11/18/2011 11:19:56 AM PST by Jack of all Trades (Hold your face to the light, even though for the moment you do not see.)
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To: Qbert
Everyday we get multiple reminders of the gubments attempts to destroy us.

When will it be stopped?

4 posted on 11/18/2011 11:21:26 AM PST by Drill Thrawl (The patient is too far gone to save.)
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To: Jack of all Trades
Not to mention what it does to the babies.

Babies? You mean the "obligate parasitic fetus"? It's only a baby if mommy wants it . . . it's garbage if mommy doesn't want "IT"!

5 posted on 11/18/2011 11:26:21 AM PST by laweeks
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To: Drill Thrawl

“Everyday we get multiple reminders of the gubments attempts to destroy us.
When will it be stopped?”

—It’s going to take a long time to stop it- but the first step will begin when we stop allowing the MSM and the Dems to distract the people from the dire problems that we face. We need to be on the offensive as close to a 100% of the time as we can be.


6 posted on 11/18/2011 11:32:26 AM PST by Qbert ("The best defense against usurpatory government is an assertive citizenry" - William F. Buckley, Jr.)
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To: Qbert
FDA Administrator Margaret Hamburg issued a 69-page decision

A picture is worth a thousand words:


7 posted on 11/18/2011 11:35:38 AM PST by P-Marlowe (LPFOKETT GAHCOEEP-w/o*)
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To: Qbert

Someone was late on their “donation” to the Obama re-election committee!


8 posted on 11/18/2011 11:48:19 AM PST by In Maryland ("If stupidity got us into this mess, why can't it get us out?" - Mark Twain)
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To: Qbert
Here's a novel suggestion - let the patients decide for themselves. Require the manufacturer to post the report on the internet (the manufacturer can also post a response) and get a statement from the woman and her doctor that they have reviewed the information and believe the benefit outweighs the risk.

That might also have the added benefit of shielding the company from lawsuits, when they can demonstrate that these adults made informed decisions.

I can tolerate a government insisting that patients be given the information to make an informed choice before undertaking risky treatment. But once the patient is informed - it is THEIR life and THEIR choice.

Oh, and to minimize the number of women who GET breat cancer, lets provide seekers of abortions with the studies showing their increased risk of breast cancer.

9 posted on 11/18/2011 11:57:09 AM PST by In Maryland ("If stupidity got us into this mess, why can't it get us out?" - Mark Twain)
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To: In Maryland

Your position is far too rational. Democrats earnestly believe that the public is too ignorant to make informed decisions about anything.


10 posted on 11/18/2011 12:49:54 PM PST by Louis Foxwell (Government must be taken back from the thieves who have stolen it.)
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To: Qbert
Sadly, for cancer patients, as well as patients suffering from other illnesses, their physicians simply are not up-to-date on the drugs they are prescribing or on the testing tools now available which might help them and their patients.

"New Genetic Tests Help Your Doctor Prescribe the Right Drugs for You" says headline , and the article continues,

"In December 2008, the New York Times ran a story about a woman from California who had been taking a drug called tamoxifen to help prevent breast cancer. After two years of taking the drug, her doctor ordered a new genetic test that showed that her genes were preventing the drug from working properly.
“You find out you’ve been taking this medication for all this time, and find out you are not getting benefit…I was devastated” says the women. She had to stop taking tamoxifen. The good news is that she found out that the drug was not helping her and her doctor can now prescribe a drug which will work in her body. The bad news is that she could have known this two years ago if she had taken the genetic test from Day 1.
"Experts report that approximately $300 billion is wasted each year on drugs which apparently do not work in people who have certain genes. These people never receive the full benefit from these drugs. Others are getting dangerous side effects.
"For example, the blood-thinning drug warfarin is one of the top twenty drugs prescribed in the US. It is used to help prevent blood clots. If a person’s genes prevent the drug from working correctly, warfarin becomes dangerous. It is one of the top three drugs that cause hospitalization or emergency room visits. If a person has genes that allow too much warfarin to get into the bloodstream, the blood cannot clot correctly and the person can have bleeding. On the other hand, if a person has genes that prevent enough warfarin from getting into the bloodstream, the person could develop serious blood clots. The way a person’s body reacts to warfarin, tamoxifen and other drugs depends on differences in their genetic makeup."

This is true of many of the drugs used in the treatment of depression and related mental issues as well, and the side effects resulting from lack of knowledge about these genetic tests are tremendous.

Many labs now offer the tests, including LabCorp in Burlington, NC, and others, but patients often have to aggressively pursue their doctors in order to have them done.

As the above-cited article points out, these are once-in-a-lifetime tests, because they are genetic.

11 posted on 11/18/2011 12:50:34 PM PST by loveliberty2
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To: Qbert; Eric Blair 2084; SheLion; Gabz; Hank Kerchief; 383rr; libertarian27; traviskicks; ...

Let’s see, death from breast cancer or perforations and bleeding w/probability of dying from breat cancer anyway. Still, one could conceivably pull through with the drug. Seems like a no-brainer to me, but not to the FDA.

Nanny State PING!


12 posted on 11/20/2011 8:19:35 PM PST by Tolerance Sucks Rocks (Occupy DC General Assembly: We are Marxist tools. WE ARE MARXIST TOOLS!)
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To: All

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13 posted on 11/20/2011 8:20:32 PM PST by musicman (Until I see the REAL Long Form Vault BC, he's just "PRES__ENT" Obama = Without "ID")
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To: Louis Foxwell; In Maryland
Your position is far too rational.

Just what I was thinking.

14 posted on 11/20/2011 8:30:00 PM PST by TigersEye (Life is about choices. Your choices. Make good ones.)
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To: Tolerance Sucks Rocks

Thanks for the ping!


15 posted on 11/20/2011 10:53:23 PM PST by Alamo-Girl
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To: All; Qbert

“Mark gets an excellent call from a neurosurgeon who gives an inside look on what exactly Obamacare will do. For example, instead of patients, some people over a certain age will be considered, “units,” as they try to dehumanize patients and the care they receive.

excerpt http://www.marklevinshow.com/Article.asp?id=2340235&spid=32345
.....

“Ehics” panel = death panel will decide your fate. Neurological physician on Levin’s show said HHS won’t allow brain surgery for people over 70 (probably in 2014).

How do you like being called a unit rather than a person?

Mark Levin’s staff verified that the caller was who he said he was, a neurosurgeon.


16 posted on 11/22/2011 11:12:21 PM PST by Sun (Pray that God sends us good leaders. Please say a prayer now.)
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