“Cure” Author Comments on the FDA and The Avastin Story

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The Cure, published in 2009, discusses the perils of fast-tracking breast cancer drugs for approval and the consequences for women with metastatic breast cancer.

Online PR News – 07-July-2011 –In The Cure, author Antoine Maurice Devine points out what he believes are dangerous flaws in the breast cancer drug approval process that lead to poorly tested drugs that are rushed to market at the behest of pharmaceutical companies seeking not to save lives, but to profit from sales of the latest touted “cure.” Avastin (bevacizumab), which obtained fast-track approval in early 2008, is one of many such drugs.

“After these new studies were found to demonstrate no clinically significant improvement in progression-free survival, no difference in overall survival, and a poor safety profile for bevacizumab, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) voted in favor of withdrawing the approval of bevacizumab combined with paclitaxel as an effective treatment for metastatic breast cancer, a recommendation that is currently under FDA consideration. Genentech is contesting ODAC’s findings.

The data in the original NCI-funded study was incomplete, since any reports concerning serious adverse effects were not required. The data that was reported showed an increased prevalence of heart disease and treatment-related deaths. In addition, there was no discernible improvement in quality of life for Avastin users.

Genentech has been pushing for progression-free survival as an end point for determining Avastin’s success, convincing the FDA to accept the end point standard when the drug was introduced. The problem is, proving such success under this more flexible standard is very difficult and expensive. What is even more troubling is if this becomes the standard, testing for overall survival, a much stricter standard that yields more reliable and telling results, may never occur again. The bottom line is – do women with metastatic breast cancer survive or not?

Despite using Genentech’s standard for comparison in later tests, the company found no vindication. In fact, these tests showed no meaningful benefit, and more importantly, no significant difference in overall survival. In addition, the results revealed a higher incidence of serious adverse effects in the Avastin groups.

In a separate, random test, Avastin users showed 1 to 3 months of survival improvement under the progression-free standard, but no improvement in overall survival. Again, Avastin users suffered from increased risk of serious adverse effects.

As a result, ODAC voted nearly unanimously ( one against) to withdraw its approval for Avastin, seeming to also reject Genentech’s progression-free survival standard, an apparent victory for metastatic breast cancer sufferers. The matter is now on appeal.

Because some researchers and doctors continue to believe this testing method has merit, the state of progression-free survival as a meaningful clinical end point continues, but if its use becomes the standard for accelerated or even final approval, it will be more difficult, if not impossible, to obtain solid data on overall survival. In my opinion, obscurity is exactly what the drug companies want. For now, the importance of actual survival data in the FDA approval process is uncertain. Without this vital information, we will never know how effective new breast cancer drugs will be until it is too late.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.