The votes are in, and the Food and Drug Administration's Advisory Committee said unanimously that the approval of Avastin (bevacizumab) for the treatment of metastatic breast cancer should be withdrawn.
The decision did not go down quietly, with women loudly voicing their disagreement, and one saying that this shouldn't be happening in the United States of America. I could not sit there and hear the cries without feeling their pain and anguish.
But the FDA advisors were very clear in their assessment: despite treating thousands of women, there was no group of women who appeared to benefit from the drug. The side effects are real and the potential harms significant, and to have the drug remain on the market could mean that many women would continue to be exposed to the drug and possibly die as a result, without hope of true benefit.
As one might anticipate, that did not sit well with the survivors in the audience and their supporters. In a response which anticipated the protest, one of the advisory committee members implored women to look carefully at the evidence and realize that the data from the trials did not support their belief that Avastin saved their lives. Yesterday, another advisor said doctors who led their patients believe that Avastin saved their lives did a disservice to those women since the evidence did not support that conclusion.
That's a tough sell for a survivor. And it may be a tough sell for some experts as well, such as the breast cancer guideline panel at the National Comprehensive Cancer Network who made it clear at a recent meeting in March that they were unanimously of the opinion that Avastin benefits women with metastatic breast cancer.
How can such knowledgeable scientists come to such different conclusions?
This isn't the first time such an event has occurred in the annals of cancer detection and treatment. Issues such as screening mammography, PSA testing and CT colonography for the early detection of colon polyps and cancer come to mind.
The real question is how to deal with this conundrum, and how best to protect the interests of the public and the concerns of those women who were present at the hearing and those they represented.
This is not the final decision regarding Avastin. The docket will remain open for several more weeks in July to receive comments from anyone who is interested in sending them to the FDA. Then the FDA Commissioner will make the final decision. When that will happen is uncertain, but the hearing officer made clear the FDA is aware that many are awaiting that announcement.
In the meantime, it is important to remember that FDA approval for the use of Avastin in the treatment of metastatic breast cancer has not yet been withdrawn. Women currently on Avastin should have discussions with their oncologists, but likely will not stop the drug. Insurers would be wise to continue to provide coverage for women currently on Avastin for breast cancer and understand that approval is still in place. And people with other cancers should realize that today's recommendation does nothing to change the approval for their treatment if they are receiving Avastin.
The FDA's decision is not going to be an easy one. It is our hope they will make that decision with full consideration of the science and the interests of the public, and the women who have been and will continue to be diagnosed with metastatic breast cancer. For them, this decision is more than academic--it is their lives, and it is understandable why they are upset.
Hopefully, wisdom will prevail.
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