All about my circuitous navigation, after being diagnosed with breast cancer, through conventional Western medicine, alternatives to conventional Western medicine, and the ensuing mind/body/spirit explorations and epiphanies (plus numerous digressions).
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.
I'm glad to hear this, though it's too little, too late:
Avastin: Stunning Reversal
Sunday, 25 July 2010
by Ralph Moss
In a stunning rebuke to the former director of the Food and Drug Administration (FDA), an advisory panel has recommended removing the approval of the drug Avastin (bevacizumab) for breast cancer. The vote was 12 to 1 to revoke the previous approval. The panel concluded that the drug was not in fact helping breast cancer patients. . .
This so pisses me off. Never in a million years would this "pre-approval" (as described below) be allowed for any non-toxic, inexpensive, and equally "promising" ALTERNATIVE treatments.
FDA says breast cancer drug did not extend lives
PERRONE, AP Business Writer Matthew Perrone, Ap
Business Writer FriÂ JulÂ 16, 12:48Â pmÂ ET
WASHINGTON â€“ Federal health scientists said Friday
that follow-up studies of a Roche breast cancer drug show it failed to
slow tumor growth or extend patient lives, opening the door for a
potential withdrawal in that indication.
The Food and Drug Administration approved Roche's
blockbuster Avastin in 2008 based on early-stage trials showing it
shrank tumors caused by breast cancer. The decision was controversial
because drugs for cancer patients who have never been treated before
must usually show evidence they extend lives.Avastin's so-called "accelerated approval" was
based on the condition that later studies would show a survival benefit.
But in briefing documents posted online, FDA
reviewers said two follow-up studies recently submitted by Roche failed
to show that Avastin significantly extended lives compared to
Additionally, the FDA said more recent data did not
confirm the tumor shrinkage seen in earlier studies.
Patients taking Avastin showed significantly more
side effects, including high blood pressure, fatigue and abnormal white
blood cell levels.On Tuesday the FDA will ask a panel of outside
cancer experts to review the evidence on Avastin. The panel's
recommendations are not binding, but the FDA usually follows their
The FDA has the option to remove drug's approval
for breast cancer.
Avastin is also approved for colon, lung, kidney
and brain cancer. The drug was Roche's top-selling cancer treatment
last year with global sales of $5.9 billion.
Roche is headquartered in Basel, Switzerland, and
its biotech unit Genentech is based in South San Francisco.
Avastin was the first drug to fight cancer by
stopping nutrients from reaching tumors. Such "targeted therapies" were
thought to hold promise for eliminating chemotherapy, but the two
approaches are now used in combination.
Since 1992, the FDA has granted accelerated
approval to drugs based on so-called surrogate endpoints, or initial
measures that suggest the drug will make real improvements in patient
health. For cancer drugs, tumor shrinkage is considered a predictor of
Drugmakers favor the program because it helps them
get products to market sooner.
But the program has not escaped criticism from
Last fall the Government Accountability Office
issued a report saying the FDA should do more to track whether drugs
approved based on preliminary results actually have lived up to their
According to the GAO, the FDA has never once pulled
a drug off the market due to missing or unimpressive follow-up data.
I look up celebrities all the time. Google them to find out answers to whatever misc. questions about them pop into my head. I love love love the instant gratification you get on google. It's amazing. And so utterly absurd to use it the way I do.
Robert Redford just remarried for the second time (well, several months ago, but I only thought to ask the question a few days ago). He and his new wife have been living together for several years but only just tied the Big Knot. He's past 70 now, she's in her 50s, a painter.
I'm so sad that Susan Sarandon and Tim Robbins might be splitting up. Maybe they already have. I checked on them several weeks ago and at that time nothing had yet been "confirmed" but rumors were flying. I thought those two were stable as could be. At least Clint Eastwood and his current wife of many years seem solid. Ditto for Sean Connery and his lady. I know I'm showing my age here, but I also look up Brad and Angelina occasionally. Also Jennifer Aniston. Did she ever adopt on her own? Seems that was a simmering question, the last time I snooped.
Last night I fell asleep wondering how the hell Diana Krall and Elvis Costello ever ended up together. I'll be looking them up soon. I want to know how they met, all the juicy details. Photos too.
Progressives in Congress are pledging not to vote for a bill that doesn't include a strong public health insurance option—but Rep. Pelosi hasn't joined them yet. Can you call her today and ask her to sign the Progressive Caucus letter?
Our bad guys are evil. Seriously. Pure evil. If America continues to let these lying, deceptive, two-faced money monsters rule our lives, we deserve the hell we're going to get. There's no need to try and say it in a fancier or more elegant way. We're leading ourselves into something that is incredibly, impossibly, morally, ethically, spiritually, unbelievably wrong.
You can read the latest from Bill Moyer's Journal HERE, which will undoubtedly depress the shit out of you if you are hoping for real change (a single-payer system). Or you can NOT read it, not feel quite as depressed, and . . . and what?
I think it's better to read it because it's better to STAY MAD even if you don't know what to do to fight them. At the very least, staying mad will generate some kind of collective energy that might somehow counteract what seem to be some really really bad odds. I mean, if Obama can't make it happen...if he is going down the same as the Clintons did...my god. How can we live with ourselves?
I sent a donation in to MoveOn.org yesterday. It wasn't much, a nano-penny in comparison to the billions that the health industry has for lobbying and bribing, but it was better than nothing. As is my anger.
Lawsuit Seeks Increased Access to Information for Breast Cancer Patients
FRANCISCO, CA—Breast Cancer Action (BCA) is challenging the legality of
patenting human “breast cancer genes.” BCA is joining the American
Civil Liberties Union in suing Myriad Genetics (a private biotechnology
company based in Utah), that currently holds the patent on the two
human genes known as BRCA1 and BRCA2.
The BRCA1 and BRCA2 genes are present in every human. However,
people with certain genetic mutations on these genes are at an
increased risk of developing breast and ovarian cancer. Myriad holds
exclusive rights to these genes and their mutations and to the research
performed on them. Testing for the BRCA1 and BRCA2 mutations can only
be performed at Myriad labs and currently costs over $3,000.
Since 1998, when BRCA1 & 2 were first patented, BCA has
maintained that the patenting of human genes interferes with patients’
access to genetic testing and medical care.
“The time has finally arrived for the courts to decide who owns our
genes,” said Barbara Brenner, executive director of Breast Cancer
Today's tidbit: Barack Obama is a Leo (sun sign), with a Gemini moon (can be emotionally cool on the surface, but also good at communicating/articulating emotions) and Aquarius rising (humanitarian, innovative, forward-thinking). He and I share the same moon and rising signs! But my sun sign is Libra, not Leo. Leo is more fiery and dramatic; the lion wants to lead and to be heard.
He also has some strong Virgo (hard worker, detail oriented, perfectionist!) and Cancer (in touch with emotions, esp. around family) influences.
Michelle is a Capricorn - also extremely hard-working, ambitious and PRACTICAL. The strong Pisces influences in her chart, however, add a dreamier side that helps her tap into our collective unconscious.
There's one element in both their charts that (according to one website I glanced at...which I hope was a stupid website) supposedly might bring violence in the form of death or accident to either or both of them, as in assassination. Of course, we don't need a website or astrology to warn us of this possibility.
In addition to bodyguards and bulletproof glass, I think we need for every single person in America (and beyond) to pray for him. I mean that in the broadest sense of the word "prayer," because the last thing I am is religious. I mean it in the sense that I believe our thoughts and "telepathic vibes," if you will, are a form of energy that can be harnessed and directed. I believe that if we send Obama protective thoughts, the cumulative power of our collective intent will help to keep him safe and alive.
Wednesday, November 5th, 2008 Pinch Me ...a message from Michael Moore
Who among us is not at a loss for words? Tears pour out. Tears of joy.
Tears of relief. A stunning, whopping landslide of hope in a time of
In a nation that was founded on genocide and then built on the backs
of slaves, it was an unexpected moment, shocking in its simplicity:
Barack Obama, a good man, a black man, said he would bring change to
Washington, and the majority of the country liked that idea. The
racists were present throughout the campaign and in the voting booth.
But they are no longer the majority, and we will see their flame of
hate fizzle out in our lifetime.
There was another important "first" last night. Never before in our
history has an avowed anti-war candidate been elected president during
a time of war. I hope President-elect Obama remembers that as he
considers expanding the war in Afghanistan. The faith we now have will
be lost if he forgets the main issue on which he beat his fellow Dems
in the primaries and then a great war hero in the general election: The
people of America are tired of war. Sick and tired. And their voice was
loud and clear yesterday.
It's been an inexcusable 44 years since a Democrat running for
president has received even just 51% of the vote. That's because most
Americans haven't really liked the Democrats. They see them as rarely
having the guts to get the job done or stand up for the working people
they say they support. Well, here's their chance. It has been handed to
them, via the voting public, in the form of a man who is not a party
hack, not a set-for-life Beltway bureaucrat. Will he now become one of
them, or will he force them to be more like him? We pray for the
But today we celebrate this triumph of decency over personal attack,
of peace over war, of intelligence over a belief that Adam and Eve rode
around on dinosaurs just 6,000 years ago. What will it be like to have
a smart president? Science, banished for eight years, will return.
Imagine supporting our country's greatest minds as they seek to cure
illness, discover new forms of energy, and work to save the planet. I
know, pinch me.
We may, just possibly, also see a time of refreshing openness,
enlightenment and creativity. The arts and the artists will not be seen
as the enemy. Perhaps art will be explored in order to discover the
greater truths. When FDR was ushered in with his landslide in 1932,
what followed was Frank Capra and Preston Sturgis, Woody Guthrie and
John Steinbeck, Dorothea Lange and Orson Welles. All week long I have
been inundated with media asking me, "gee, Mike, what will you do now
that Bush is gone?" Are they kidding? What will it be like to work and
create in an environment that nurtures and supports film and the arts,
science and invention, and the freedom to be whatever you want to be?
Watch a thousand flowers bloom! We've entered a new era, and if I could
sum up our collective first thought of this new era, it is this:
Anything Is Possible.
An African American has been elected President of the United States!
Anything is possible! We can wrestle our economy out of the hands of
the reckless rich and return it to the people. Anything is possible!
Every citizen can be guaranteed health care. Anything is possible! We
can stop melting the polar ice caps. Anything is possible! Those who
have committed war crimes will be brought to justice. Anything is
We really don't have much time. There is big work to do. But this is
the week for all of us to revel in this great moment. Be humble about
it. Do not treat the Republicans in your life the way they have treated
you the past eight years. Show them the grace and goodness that Barack
Obama exuded throughout the campaign. Though called every name in the
book, he refused to lower himself to the gutter and sling the mud back.
Can we follow his example? I know, it will be hard.
I want to thank everyone who gave of their time and resources to
make this victory happen. It's been a long road, and huge damage has
been done to this great country, not to mention to many of you who have
lost your jobs, gone bankrupt from medical bills, or suffered through a
loved one being shipped off to Iraq. We will now work to repair this
damage, and it won't be easy.
But what a way to start! Barack Hussein Obama, the 44th President of the United States. Wow. Seriously, wow.
I was confused at first. Just a photo.... but then I began to look at it more closely, and to move my cursor around...and click on things. I suggest you do the same. It IS fun.
Let's hope it gets distributed widely.
Oh wait, I see more instructions underneath the "have fun with it" line. It urges you to click and/or doubleclick on just about everything in the room. Even things that look "normal." In the world of Sarah Palin, even that which at first glance appears normal just may not be....