Today, December 16, the US Food and Drug Administration (FDA) took steps to disallow the use of Avastin (bevacizumab) in breast cancer. This overturns the previous director’s approval of the drug two years ago–a decision that was medically unwarranted but was worth hundreds of millions of dollars to Roche.
Dr. Richard Pazdur, the FDA’s chief of cancer drug review, said, “Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio.”
I applaud this decision, as the data behind the use of Avastin in breast cancer was always very shaky. The company, however, is expected to appeal the ruling.
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Sure seems to be effective for Ovarian Cancer.
By: Janet Wilson on December 16, 2010
at 8:13 pm
Its failure in one kind of cancer does not necessarily imply that it is not effective for other types.
By: themossreports on December 16, 2010
at 11:40 pm
Janet: Is your comment from personal experience? My husband’s oncologist is recommending Avastin for my husband right now (4th round stage 4 kidney cancer, a rare aggressive subtype) along with chemo. He is young and active and side effects have me concerned. He had carboplatin & taxol with success (an ovarian regimin).
By: Lynee Sapere on December 19, 2010
at 11:27 pm
Excellent, everyone is seeing how few clothes the Emperor has!
By: Patricia Peat on December 16, 2010
at 11:28 pm
In a sense, I am pleased to see the FDA change its published decision. This can serve as an example of FDA independence from Big Pharma. I wish there were more such examples in what I see as a very troubled agency.
By: GordonK on December 19, 2010
at 2:40 pm
I also applaud this decision. As a breast cancer survivor I find this toxic chemo drug not worth the side effects. I have seen several breast cancer patients take this with no visible health benefits.
By: sherri on December 19, 2010
at 6:13 pm
The problem from the beginning is that Avastin was NEVER a “breast cancer drug”.
Nor is a colon cancer drug, lung cancer drug, etc. It’s target is VEGF (vascular endothelial growth factor). This target can be found in some breast cancers, some colon cancers, some lung cancers, etc. Until we begin doing meaningful research with molecular analyses of tissue sample looking for this and other targets on ALL cancer patients, we’re wasting our research dollars and people’s lives because the few breast cancer patients who express VEGF and may be helped by Avastin, will be washed out statistically by the majority who don’t express VEGF and therefore won’t respond.
By: Richard Linchitz MD on December 19, 2010
at 9:51 pm
Dr. Linchitz raises a good point but the use of Avastin like all other toxic attempts to kill cancer cells, fails to address the environment that allowed the tumour to grow namely the patient surrounding it. Breast cancer patients with inactive NK (Natural Killer) lymphocytes have an increased recurrence and earlier mortality rate compared to those with active NK cells. What is not generally known is that mercury in the blood from dental amalgam has been proven to kill lymphocyes (hence very inactive) as well as depleting glutathione the major intracellular antioxidant. This evidence supports the late Dr. Issels, the renowned German oncologist’s contention that 98% of the over 12,000 patients he treated had significant causal factors in teeth, jaw and tonsils. Doctors’ examinations need to also include their patient’s teeth.
By: mike godfrey MD on December 20, 2010
at 6:06 pm
How can a person determine whether their NK lymphocytes are active or inactive? What kind of test reveals this?
By: Annie on December 27, 2010
at 5:32 pm
A number of labs offer an NK test. Here for instance is one of them:
http://getdrlam.com/nk_cells_test
This is for general information only, as I cannot attest to their quality. RWM
By: themossreports on December 28, 2010
at 1:36 pm