This week, the federal Food and Drug Administration announced its withdrawal of approval for Avastin, a commonly-used breast cancer drug.
Avastin, the trade name for the drug bevacizumab, is one of a class of drugs known as “biological therapy.” The drug is a product of Genentech, a biotechnology company based in San Francisco, California.
Avastin is designed to inhibit or prevent the growth of blood vessels which feed cancerous tumors, thus inhibiting or even reversing the growth of the tumors themselves. The drug itself is an antibody, which binds to a specific protein known as vascular endothelial growth factor A. This protein is important in blood vessel growth and development in the human body.
The drug thus works through a process known as anti-angiongenesis. Cancerous tumors over-produce VEGF, which then works to form blood vessels connecting to the tumor, so that the tumor can receive nourishment and grow. The process was developed by Judah Folkman, a recently-deceased surgeon with Harvard Medical School.
Although the process took a long time to gain credence, there are now at least 10 drugs utilizing anti-angiongenesis sold in the United States, and industry reports reveal that roughly 50 more such drugs are in the development pipeline.
The FDA’s revocation does not extend to Avastin’s other approved uses. The drug is still approved for the treatment of metastatic colorectal cancer, advanced non-small-cell lung cancers, gliobastoma which has spread even after prior treatments, and certain metastatic kidney cancers.
The FDA’s decision to revoke Avastin’s approval for breast-cancer treatment is based upon what is, to our drug injury attorneys, a particularly troubling combination: lack of effect and dangerous side effects.
First, the drug in fact has no effect on breast cancer. Despite some initial slowing of the growth of breast cancer tumors, patients treated with Avastin did not have an increased survival rate, or live longer, than patients not treated.
Second, the drug triggers a number of extremely serious side effects.
Indeed, roughly 1% of Avastin patients died not from breast cancer, but from side effects of Avastin. These side effects include (among others) heart attacks, strokes, and congestive heart failure.
Moreover, the company was hardly unaware of the concerns which triggered the removal of approval, even as it continued to market and sell the drug as a breast cancer treatment. Even from the early days of the drug’s approval, there were many questions concerning whether the drug had any meaningful effect on breast cancers. In fact, when the drug was approved, it was despite the 5-to-4 recommendation against approval by an advisory panel. Although the FDA considers the recommendations of its independent advisory panels, it is not bound to do so.
Studies since have simply confirmed what many researchers were already saying: Avastin does not improve patients’ chances of survival, or prolong patients’ lives.
The move to revoke the approval began in July of 2010, when a second advisory panel recommended withdrawal based on further studies showing no benefit. But it took until December of 2010 for the FDA to take any action to begin the withdrawal – action that was fiercely challenged by Genentech. Yet another advisory panel conferred, and took testimony on the matter for two days, eventually voting unanimously to revoke the approval – a vote which did not occur until June of this year.
Our personal injury attorneys are appalled that, even with the overwhelming evidence that Avastin was costing lives, not saving or prolonging them, the company continued to actively market and sell this drug, under the FDA’s approval. There is no excuse for a bureaucratic process lasting nearly a year and a half before this confirmed dangerous drug could be withdrawn.
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