For women everywhere, here’s the true lowdown on Avastin for breast cancer

Straight talk in the Tower of Babel

I’m not sure I knew what breast cancer was the first time it took someone I cared about.

She was my mother’s closest friend. They’d grown up together and were there for each other’s weddings, when their children were born, and through all of life’s joys and hardships.

Phylis was young…maybe in her early 40s when it happened. And from diagnosis to when she passed was only about six months.

It’s a disease every woman fears. And it’s ruthless — striking when and how it wants, leaving women frightened and, too often, not knowing what is the best treatment option.

That’s why all the recent confusion over Avastin use for breast cancer is even more maddening.

There are women who passionately believe Avastin saved their lives. But still, an FDA panel voted to rescind approval of Avastin for breast cancer treatment.

And now an organization of oncologists has refuted the FDA, renewing a recommendation of the drug for breast cancer patients.

Imagine if you or someone you love were struggling with the decision of whether to include Avastin in your treatment plan — on top of facing a diagnosis of breast cancer.

So for every woman who feels aggravated by this Tower of Babel bickering, here’s a clear-eyed look at the REAL backstory of Avastin.

Delay of game

Avastin is a true blockbuster drug, used to treat several forms of cancer.

Last year’s sales of Avastin totaled nearly $7 billion, and $1 billion of that came from breast cancer patients.

Which brings us to Avastin’s controversy number one: It costs a patient between $50,000 and $100,000 per year.

Now, if every oncologist was completely honest and forthcoming with every breast cancer patient, they would make the cost of the drug very clear. Then they would carefully review potential adverse effects. Here’s a partial list from the Avastin website…

* Gastrointestinal perforation — sometimes fatal (an FDA release notes that perforations may occur in the nose, stomach, and intestines)
* Serious bleeding in the stomach or brain — sometimes fatal
* Severe high blood pressure that may cause stroke or heart problems — sometimes fatal
* Kidney problems — sometimes fatal
* Vision disturbances — including blindness

So you’ve got the outrageous cost coupled with nightmarish side effects. At that point, many patients would be out the door. But some would stay long enough to ask: “Does it work?”

Studies answer that question with mixed results. Like any drug, it works for some and not for others. But when an FDA panel reviewed four Avastin studies last year, they voted 12-to-1 in favor of withdrawing the agency’s 2008 approval of the drug for breast cancer.

The panel concluded, and the agency agreed, that the drug didn’t prolong overall survival, and whatever benefit there was in slowing disease progression was not sufficient “to outweigh the significant risk to patients.”

Game over? Not at all. Roche, the maker of Avastin, appealed the decision. So the FDA scheduled a public hearing this past June. And after two days of emotional testimony, the panel voted 6-0 to uphold the FDA’s decision to withdraw approval.

Now is the game over? No. Just the opposite.

The 800-lb gorilla

A few days ago, the National Comprehensive Cancer Network (NCCN) voted to continue its recommendation to use Avastin for breast cancer.

NCCN is a non-profit organization of oncologists. And for leading treatment centers, Medicare, and insurance companies, their recommendation is so powerful that it will actually overcome a retracted FDA approval.

I’ve got to admit, that’s impressive.

But before you make your decision about treatment, there’s one last detail you need to know…

NCCN is deeply entrenched in the Big Pharma culture.

According to Pharmalot, 10 of the 33 members of NCCN’s breast cancer panel have ties to Roche as “advisory board members, speakers, consultants, expert witnesses or having received clinical research support.”

And on the NCCN website’s listing of organizational relationships, you’ll find drug companies, large and small, including Pfizer, Wyeth, GlaxoSmithKline, Eli Lilly, Novartis, etc.

You won’t hear me say this very often, but I would listen to the FDA on this one. They had it wrong at first, but then they got it right. Twice.

Game over.

Sources: 
“NCCN Still Recommends Avastin For Breast Cancer” Ed Silverman, Pharmalot, 7/21/11, pharmalot.com

“U.S. FDA panel rejects Avastin for breast cancer” Reuters, 6/29/11, reuters.com