Avastin’s no longer an option. Good.

From autoblog.com

By Lori Kim

Cancer is a terrible disease taking millions of lives every year.  According to Breast Cancer Facts and Figures for 2009 – 2010 reported by the American Cancer Society, the two types of cancer that lead to the most deaths in women are lung and breast cancer.  In 2009, approximately 40,170 women are expected to die from breast cancer.  Breast cancer is one type of the disease and unfortunately can hit women the hardest.  While the traditional route of chemotherapy is an option, Genentech offers another option as cancer treatment: Avastin.  Back in December of 2010, the Food and Drug Administration decided to attempt and remove an approval for Avastin as a safe drug for the treatment of breast cancer.  The latest news surrounding Avastin was declared on June 29, 2011 that the FDA would pull the approval for Avastin to be prescribed for breast cancer treatment.  However, doctors may prescribe Avastin but certain insurance companies might not choose to insure the costly prescription.

The debate with the FDA lasted for about a week and the news surrounding it exploded.  Google News offered a headline for Avastin for days as a top story link.  Articles and videos reporting on the hearing and opinions were everywhere.  The debate surrounding Avastin, which also included another drug called Provenge, became a hot topic based on the focus of testimony from women in support for Avastin pleading with the FDA to allow the approval.  Genentech offered another option as opposed to pulling the approval for Avastin altogether.  Genentech suggested allowing Avastin to retain its approval while it conducted other studies to acquire more conclusive results.  The FDA voted on the matter and in a unanimous vote decided to remove the approval for Avastin to treat breast cancer.  This issue is a tough case to call as many women testified to the effects of Avastin yet Genentech failed to produce conclusive evidence that women who took Avastin proved to live longer with a better life.  Although it is difficult to agree, the FDA made the right decision in pulling the approval for treatment of breast cancer.

According to the Washington Post, Avastin works by starving blood vessels from building blood vessels that carry oxygen and nutrients, essentially depriving it.  The “traditional” method of chemotherapy kills cancer cells thereby not allowing them to divide and multiply within the body.  While the traditional method of chemotherapy offers side effects such as low blood-cell counts, nausea or vomiting, hair loss, weakness and bleeding, Avastin’s possible side effects were listed as high blood pressure, bleeding, development of holes in the stomachs or intestines, heart attack or heart failure.  The side effects are far worse in comparison to the hair loss that usually associates chemotherapy treatments.  Avastin was originally granted approval in February 2008 as an alternative for breast cancer treatment based on a study that showed Avastin slowing tumor growth by an average of 5.5 months.  However, the FDA’s Center for Drug Evaluation and Research recommended that the approval be withdrawn once other test results came back with “less impressive results.”  In comparison, Avastin is approved as a breast cancer treatment in Europe and the National Comprehensive Cancer Network considers it “a viable option.”

It is difficult to agree with the FDA because they’re essentially pulling a drug that seems highly  beneficial to some women.  Terrence D. Kalley founded the Freedom of Access to Medicines, whose aim is fight the FDA’s Avastin decision, based on personal experience and success with Avastin.  His wife was prescribed Avastin a couple years ago after battling cancer for almost thirty years which Kalley attributes her success and health to Avastin.  These women have been called “super responders” to Avastin while others reportedly died of gastrointestinal hemorrhaging days after starting Avastin.  The spectrum of the results within the drug seem to make it unfair to those who died using Avastin or the women who would not be able to testify at the hearing.  However, Christine Brunswick, the vice president of the National Breast Cancer Coalition testified not to keep Avastin approved for breast cancer, but urged the FDA to pull the approval.  She argued that we cannot let emotions cloud the judgment of whether the drug works or not, rather we should rely on science.

Originally, this was a no-brainer situation and it would be stupid to take a drug off the market that clearly helps breast cancer patients when the only other viable option is chemotherapy.  However, at what price should the drug be allowed to be prescribed?  It can still be prescribed and made available to patients.  Moreover, Medicare announced and confirmed it would still continue to cover Avastin regardless of the outcome on the approval.  While it is costly to take Avastin, Medicare is helping make it an option for those insured.  In reality, the FDA chose to remove its approval on Avastin for the greater population of cancer patients rather than focus on the few “super responders” who haven’t experienced holes in their intestines or worse.  Genentech should head back to the drawing board and reevaluate Avastin and the side effects such as the holes in the intestine and stomach.  They were able to get Avastin approved before and with improvements, more women can be “super responders” instead of a handful.  Another option is for Genentech to appeal the decision and leave the absolute final decision to the FDA commissioner Margaret Hamburg.  The FDA may be getting some harsh words and angry responses based on their decision but the women who feel so strongly should realize the results were not 100% across the board.  Did they forget about the women who weren’t considered “super responders” or the women who couldn’t make it to testify that Avastin did respond quite as well with them?  Avastin is still available for prescription and can be covered by Medicare yet the true greater good will come once Avastin can turn the “super responders” into everyday responders.  Only then should Avastin regain its approval for breast cancer.


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