FDA fast track drug approval puts patients at grave and unnecessary risk
No Need for Speed
It’s a scam, plain and simple.
Supposedly, in the name of helping people, the FDA puts drugs on the “fast-track” to approval. In reality, it’s all done to let the Big Pharma companies gouge the consumer sooner, without having to fully prove that their drug works — or is even safe enough to take.
And it couldn’t be more infuriating. Patients and their families–in their most vulnerable moment–are the ones who lose big time when drugs are rushed to market.
The most recent fast-track disaster is a cancer drug called Avastin.
But Avastin isn’t just any cancer drug. It’s the best selling cancer drug in the world. In 2009, Genentech (the maker of Avastin) collected more than $6 billion in sales of this one drug alone.
Of course, you’re likely to put up pretty impressive sales totals when you charge patients about $40,000 for a single course of treatment.
Obscene? Well, if Avastin actually cured cancer, $40,000 might seem like a bargain. But the only promise with this “wonder drug” is that cancer patients may live a few additional months when Avastin is combined with chemotherapy and other cancer treatments.
But it turns out, even THAT meager promise was a little too optimistic in the case of a specific type of breast cancer.
Fatal flaws
An FDA advisory panel recently voted 12-1 to overturn the 2008 fast-track approval of Avastin in treating HER2- negative breast cancer. The reason: In two follow-up studies since the 2008 approval, patients with this type of breast cancer didn’t survive any longer than patients taking other drugs.
But the real deal breaker was the adverse events. If there’s no benefit, but proven adverse events, well…not even the FDA can defend that one.
Patients in the two studies developed fatigue, high blood pressure, and other side effects. And when you start talking adverse events with Avastin, things get real dark real fast.
Check “important safety information” on the Avastin website and here’s the first thing you’ll find: “Avastin can result in the development of a potentially serious, and sometimes fatal, side effect called gastrointestinal (GI) perforation.”
And that’s just getting warmed up.
Other primary adverse effects include “incomplete wound healing”–sometimes fatal–as well as “fatal bleeding” in the stomach and brain. And then there’s this side effect, which is one of the most bizarre I’ve ever seen: “The formation of an abnormal passage from parts of the body to another part, sometimes fatal.”
In case you aren’t keeping count, the word “fatal” is used FOUR times!
Can you imagine taking a drug like this while also coping with the harsh side effects of chemo? Not to mention being a cancer patient and taking a drug that may kill you faster than the disease it’s supposed to cure!
What’s mind-boggling is that even if FDA officials follow the panel’s recommendation to revoke Avastin use with HER2- negative breast cancer (and we can’t assume anything with these guys), this drug will still be available for use with other types of cancers, such as lung, colon, kidney, and brain cancers. (We’ll have to wait and see if more Avastin research will be coming along for these cancers.)
And so the billions will keep rolling in for Genentech. It may not be quite so many billions next year, but don’t worry–their coffers will still be filled to bursting.
If you or someone you love is fighting cancer, please make sure there is a long list of pros before you even consider Avastin…because the cons could put you on the wrong fast track.
To Your Good Health,
Jenny Thompson
Sources:
“FDA Advisers Say Avastin Shouldn’t Be Used for Breast Cancer” HealthDay News, 7/20/10, consumer.healthday.com
“FDA panel recommends rescinding Avastin for breast cancer” Ron Leuty, San Francisco Business Times, 7/20/10, bizjournals.com
