One More on the Avastin Travesty

It's hard to believe that the FDA can abuse their power THIS much. I really hope that the new commissioner, Hamburg, is better than Eschenbach, but I'm so jaded by now, I don't hold out much hope that she will be.

Can you imagine how this affected all those hundreds of thousands of women who took this useless drug? It was added to chemo, so their already devastating side effects were made even worse. And can you imagine how their insurance premiums must have skyrocketed? (It costs $50,000 to $100,000 a year.) And can you imagine how betrayed they felt when they learned that it did next to nothing? And what's sad is that most of them probably have no idea that they had so many other alternatives they could have been trying, instead.

That's the saddest thing of all.

Sunday, 01 August 2010



Avastin was given a preliminary approval for breast cancer based on early studies that did not include survival data. The advisory committee agreed unanimously that two new trials failed to confirm the impression of benefit of the earlier studies. In particular, use of Avastin failed to prolong overall survival in the women who received it. In one study, the drug delayed tumor worsening by one month. In simple terms, Dr. Patrick Loehrer, Sr. of Indiana University (and a panel member) said, "It just delays by another visit before they get the news that their tumor progressed." An FDA panel had voted in December 2007 by a 5-4 vote to recommend against approval. But the FDA commissioner of the time, Andrew C. von Eschenbach, MD, then overruled his own panel (something that's almost never done) and approved the drug....a decision that turned out to be worth around $500-700 million per year to Genentech.

However, FDA almost never revokes approval once it is granted. Thus, a government report has shown that of the 90 drugs given accelerated approval not one had been removed from the market and in fact the agency sometimes did not make sure that follow-up studies were done. It will be an interesting test to see how the new FDA commissioner, Margaret A. Hamburg, MD, reacts to this nearly unanimous panel recommendation.

Comments

[Jill]

And then there's this.........sigh....

http://www.ktrh.com/cc-common/news/sections/newsarticle.html?feed=121300&article=7501834

Jill

[Jill]

Unfuckinbelievable! We're just a bunch of money raising guinea pigs to them!
Not exactly the same, but reminds me of all the millions of women's lives messed up because of unnecessary hysterectomies and ovary removals (HUGE money making surgery which is STILL going on!)

Can you see the steam comin out my ears?!

Jill