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 ...
That was a quite astounding feat. We'd hope that it became commonly available particularly since I may well need one myself.
Who do you believe, lawyer and activist, Fran Visco or Dr. John Durant?
FRAN VISCO: High-dose chemotherapy with bone marrow transplants for breast cancer is not an effective therapy.
DR. JOHN DURANT: It’s way premature to say this strategy doesn’t work. I think the strategy will continue to be of interest as a means of improving survival.
Thanks!
If anyone actually read my post....in the USA Avastin is around $100k per year. Who can afford that, even if it is cheaper in another country?
Agreed. Yes, we need to be able to get all the care we need here at home, I was just pointing out alternatives until we get Old Jugears out of office and rein in these agencies. You are correct though.
What’s ironic is the USA is the “medical tourism” destination for whenever some Saudi Prince or European billionaire needs a highly specialized super-expensive operation. Just recently one of those Arabs was here at one of our prestigious hospitals. They create a huge luxury suite for these guys, gourmet food, top medical staff and attention. And probably a few floors down is some little old lady on Medicare shivering in a cold room desperately pushing her call button to ask for a blanket.
there's big money in drugs....who gets their drug out on the market, who doesn't and plenty of payoffs inbetween...
know any drug reps?....if you did, you'd know that they live the high life without the study, the anxiety, the long hours of actually being a doctor....
Since I had never had Chemo before, I thought the sensation was just part of it, them I looked down and saw some discoloration next to the IV.
I called for the Nurse and she ran in there like nobody’s business, turned off the drip and got the needle out of my arm before I knew what was going on.
I'll assume that is the same 1% to 3% problem they have with the Avastin, which has more to do with the IV Setup than the drug be utilized for the treatment.
Unfortunately, taking a promising drug off the market only leads desperate people to seek out alternative treatments like going to Mexico for a magic Cancer Cure. It didn't work out for Steve McQueen did it?
Government only causes havoc while stifling innovation.
Questionable is how all manner of studies are thrown in the hopper and a blanket conclusion drawn — rather than looking for reasons why some seemed to show good success and others had no results or negative results. It’s darn hard to control all the factors with a disease as slippery as cancer and with nursing expertise in administering a drug as intended varying widely.
In the end, the HIV drug cocktail is not and cannot be a cure. Why stop one and not the other?
When I fell out of Remission, I went back into Chemo using the same cocktail of Drugs with a slight variation on dosage. Although my numbers improved after that second treatment, I am still not where I was and most of my numbers are below normal levels.
No matter the treatment, no matter the Miracle Drug, it may work on some but not all. Unfortunately, there will always be an attitude that if the treatment is not 100% effective in 100% of Patients, the Government shouldn’t allow its use.
Kind of reminds me of the CSI syndrome that is prevalent on today's Trial Juries. Beyond a reasonable doubt has become must be proved with 100% certainty. If it's on a TV Show, it must be true. Instead of CSI it's House the miracle worker.
your kidding I hope.
There are scientists who are working 80 hour weeks in those evil pharm companies and do it for 20 years.
Drug reps are the people you see in Drs. offices and NOT representative of 1/200th of what goes on in drug companies.
I am a breast cancer survivor so nothing a stupid activist attorney says carries any weight in my world.
thank heavens.
Those that can’t do, sue.
How can a profession be arrogant? You’re not thinking, yet again.
It’s non thinkers like you who scream for the all powerful, good hearted geniuses working in government bureaucracy to come save everyone from “arrogant” professions.
I’m sorry you’re unable to use your food stamps to buy a clue.
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