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 ...
The upfront investment for the development of a new drug is 1 BILLION dollars.
If the FDA wants more studies, more patients in the studies and as is often the plan dictated now, life long follow up on the patients status once it is approved.
Now if the drug is not approved, a couple billion down the tubes. Understand that the FDA knows and approves each step and each study of each stage of development and clinical testing of each drug. So after a couple billion is invested, someone says, eh, sorry, no thank you.
So that money necessarily must be recouped with the success and or approval of the next drug in addition to the money invested in development of the new drug.
Understand that the drug company sees only 18 cents on the dollar of each dollar charged at the drug store. The rest goes through the stores, overhead of the store employees, shipping, government and liability insurance for each person along the chain of possession. That is the big sucker.
AND the company has 7 years to make back the investment before it goes generic.
My MS infusion is once a month and is 2200 each treatment. Biologics are especially difficult to develop.
Please don't think me heartless or overly blunt, but he needs to spend the next five minutes getting his ass on the road to Mexico or Canada or the Bahamas or anywhere else where he can get Avastin for his wife, and smuggle a supply of it in and administer it to his wife himself if need be. Screw the bureaucrats. Who made them God? Certainly not that jughead Obama.
Yes, I get my infusion in a local doctor owned clinic and the difference in cost is 500 per month.
Or to recoup losses from selling to various national health systems below cost.
I could be wrong but IIRC, Obamacare will be eliminating off label use to save money.
“My MS infusion is once a month and is 2200 each treatment”
It doesn’t seem to slow you down any. Thanks for all the work you do and the guests you have on your show are awesome!
It slows me down a lot. Some days I cannot walk or feed myself.
If I knew how much I could have done when I was well, I’d ‘ve been freakin’ dangerous. You don’t know what you’ve got until its gone.
As it is, one show a week is all I can do.
excellent point, TpB
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Most cancer patients have a portocath so the danger you are talking about hardly exists. Avastin is an expensive drug. It can cost up to $100k a yr and I am sure that has something to do with why no one wants to cover it.
I received avastin as part of a UCLA trial for breast cancer. Since I was part of the trial my insurance was never billed for it. UCLA is still tracking me.
Esactly sheana.
Tysabri is my drug which was taken off the market for treatment of MS because it was “too dangerous”, albeit very effective.
Well crap if you are going to be rendered useless by a progressive disease, wouldn’t you rather die trying?
I wish you good luck. So far I am clean. Recently had my yearly scans and haven’t got the results back yet. Fingers crossed.
But you have proven the government bs on Avastin to be a lie haven’t you?
I do not know how can NOT be effective. If it cuts the blood supply to the tumor, how can the tumor survive? Makes no sense. I can see that the tumor could develop alternate vessels but regular treatment would slow that effectively I would think.
The fact that you are still being “followed” proves that it was effective, doesn’t it?
I sit in the clinic for my infusion every month with mostly cancer patients.
Avastin was not the only drug I was given. I went through the regular chemotherapy with the add ons of Avastin and Herceptin. Apparently they are an effective combo for the type of breast cancer I had....HER2.
From everything I have read about Avastin, they really wanted it to be effective for other cancers plus they found out it was useful in prolonging the lives of Stage4 cancer patients.
I honestly don’t think they know that much about Avastin yet. There are still trials running everywhere on it.
Oh, I think they know plenty. Trials still running are an indicator of a desire to seek additional approvals for a broaded label.
Can you go to Mexico, Costa Rica, Grenada, Belize, India, wherever to get the drug? Bammycare will create a new boom in medical tourism.
What typical American has money to go globe-trotting after drugs? Especially considering one family member, the ill one, is already out of a job, and possibly another one (spouse, adult child) to care for the ill person. Then even in another country we still have to pay for the drug. And possibly pay a private nurse there or back home to administer it intraveiniously. Could be talking thousands of dollars.
But it’s not just the money. WE ARE ENTITLED to whatever drugs we want that our doctor approves, right here in America. The fight should be against the FDA and whatever other govt agencies are interfering with our rights. I hope people will focus on fixing our system, not creating a medical tourism boom.
Sounds good ~ to be tracked means you are still among your loved ones. Wish you the best.
Fran Visco is an American lawyer and activist.
Visco is the first president of the National Breast Cancer Coalition and Fund
Visco was a partner in a Philadelphia law firm before leaving law to focus on NBCC/F’s work.
In 1993, President Clinton appointed Visco as one of three members of the President’s Cancer Panel, and she was the first consumer to chair the Integration Panel of the Department of Defense Peer-Review Breast Cancer Research Program.
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