More FDA chicanery.......FDA revokes approval of Avastin for breast cancer

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FDA revokes approval of Avastin for breast cancer
 
by NewsChannel 36 and LAURAN NEERGAARD / AP Medical Writer

Posted on November 18, 2011 at 11:33 AM

Updated today at 12:08 PM

WASHINGTON (AP) -- The Food and Drug Administration has declared the blockbuster drug Avastin should no longer be used in breast cancer patients because there's no proof it extends their lives -- and it is causing dangerous side effects.

Friday's ruling was long expected, but is sure to disappoint women who say they've run out of other options.

Shannon Morgan of Charlotte went before an FDA panel in the summer with her husband to lobby for the drug to be approved.  Morgan was given two years tops to live.  After meeting a Huntersville doctor who prescribed Avastin, she is now in remission.

FDA Commissioner Dr. Margaret Hamburg called the decision difficult but said patients must have confidence that drugs sold for their condition are effective.

Avastin won't stop selling, as it's also used to treat colon cancer and certain other tumors, but the FDA ruling is expected to influence insurance coverage. Medicare says it will continue to cover Avastin while it evaluates whether a change is needed.
http://www.wcnc.com/news/local/FDA-revokes-approval-of-Avastin-for-breast-cancer--134121338.html]
[url]http://www.wcnc.com/news/local/FDA-revokes-approval-of-Avastin-for-breast-cancer--134121338.html[/url]

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Will outcry of breast cancer patients sway federal official?
Posted by CW Editor on July 7, 2011 in News | 0 Comment

Three from Mecklenburg speak their piece at D.C. hearing on Avastin

by Frank DeLoache

South Charlotte resident Shannon Morgan (above) and her husband, Pat Morgan, both testified in front of the U.S. Food and Drug Administration in favor of the breast cancer drug Avastin. Dr. John Powderly, of Huntersville, joined them in Washington, D.C.

WASHINGTON, D.C. – Shannon Morgan went to the nation’s capital to fight for her life.

Her husband, Pat, accompanied her for the chance to look federal administrators in the eye and tell them their system is broken and harming the breast cancer patients they are supposed to protect.

Dr. John Powderly, Shannon Morgan’s physician-oncologist and a cancer researcher, tried telling members of the medical panel in terms they could understand that Avastin is the only drug working for Shannon and a large group of stage IV breast cancer patients.

The Morgans, from south Charlotte, and Powderly, from Huntersville, were apparently the only three people from North Carolina to testify at the June 28 hearing about continued federal approval of the drug Avastin in treating breast cancer.

Shannon and Pat Morgan came away from the hearing angry, fighting mad. They both said the members of the U.S. Food and Drug Administration advisory panel paid little attention to the testimony of dozens of patients and doctors who came from across the country. And they were not surprised the panel reaffirmed its earlier recommendation to remove federal approval of Avastin as a treatment for breast cancer.

“I’m fighting for my life,” Shannon Morgan said after returning to her south Charlotte job later in the week. “I felt like I should be up there and give it my all. I did, and I feel great about that. If they want to be a bunch of idiots, it’s on their consciences.”

“They acted like they were bored and just wanted to be somewhere else,” Pat Morgan added. “This is the same fox that was in charge of the hen house before. The hearing was just a show to act like they really cared. This was a sham.”

Powderly was not surprised by the panel vote either. He thinks guidelines federal officials use to judge drugs are flawed and should be changed.
Read More Here: http://www.thecharlotteweekly.com/news/2011/07/will-outcry-of-breast-cancer-patients-sway-federal-official/

The FDA are a bunch of heartless crooks!

[ivanm]

Yeah, like who do they think they are protecting with this asinine policy?

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An Extra Month of Life: Is it Really Worth the Cost?


The accelerated approval program, which was created in the early 1990s as a way of rushing promising AIDS drugs to market, requires companies to conduct additional clinical trials to confirm the promise shown in the earlier test. However, when the new trials came in last year, they not only didn’t show any increase in overall survival, they failed to fully replicate the delay in tumor progression seen in the original trial.

That scientific evidence was of little interest to the dozens of breast cancer patients, their families, physicians and advocacy groups who showed up at the hearing to offer emotional testimony in favor of the drug. Shannon Morgan of Charlotte, N.C., who has survived a diagnosis of metastatic breast cancer for over two years, insists she is alive today because she was treated with Avastin (the median time of survival in the original trial was 24.8 months on chemotherapy alone, compared to 26.5 months on chemo plus Avastin; statistically there was no difference, meaning the results could have been by chance). She’s afraid her insurance company will stop paying for the drug if the FDA withdraws approval.

“You may be rich but I am not,” she testified. “If you take Avastin for breast cancer off the label, how many of us successful users will die during that time? Do you want that on your conscience?”

The fears and hopes of patients like Morgan lie at the heart of the nation’s emerging struggle with the rising cost of cancer care, which is one of the major drivers of rising Medicare costs. A study that appeared earlier this year in the Journal of the National Cancer Institute estimated the U.S. paid about $125 billion for treating the 16 most common forms of cancer in 2010. By 2020, that tab is likely to grow to $173 billion because of the aging of the population and the rising cost of new drugs and other therapeutics.

Read More Here: http://www.thefiscaltimes.com/Articles/2011/06/30/An-Extra-Month-of-Life-Is-it-Really-Worth-the-Cost.aspx#page1