The FDA Strikes Again

The FDA Strikes Again

The folks at the FDA are continuing their pursuit of limiting therapy options for patients only this time it’s not diabetes patients who will be suffering but women with breast cancer. Yesterday, the agency announced they would be following the recommendation of an FDA panel, and will be withdrawing their approval for Avastin as a treatment for breast cancer. According to Janet Woodcock the FDA’s top regulator; “Patients treated with Avastin did not live any longer than patients who were not treated with the drug. A drug’s ability to extend life is viewed by the FDA and many oncologists as the gold standard.”

This decision was widely criticized and Roche, the makers of Avastin, plans to appeal the FDA’s decision.

Just as they done with several diabetes drugs, the FDA is once again limiting therapy options for patients. Although Diabetic Investor is no expert when it comes to breast cancer or the various treatment options used to fight this disease, we do know that breast cancer is a serious issue and women need more, not less options, to fight this terrible disease.

For anyone who believed the FDA was somehow changing their tune and become less conservative, this decision shows the agency remains in the ultra-conservative mode. What makes this decision even worse is it shows that the agency basically believes women with breast cancer and their physicians cannot think for themselves. According to the Susan G Komen website, nearly 40,000 women will die this year due to breast cancer and over 207,000 new cases of breast cancer will occur.

The FDA is basically claiming the data does not support the use of Avastin for breast cancer and according to Ms. Woodcock breast-cancer patients on Avastin “were at greater risk of experiencing severe side effects,” such as life-threatening internal perforations, severe high blood pressure, bleeding and hemorrhaging. Roche obviously interrupts the data differently, as do European regulators who will continue to approve Avastin as a treatment option.

What this decision has in common with others made by the agency regarding diabetes drugs is the agencies belief they know better than everyone else. Should the decision of whether to follow a particular therapy option be left to the patient and physician? Or should the FDA take away this ability and not allow the physician and patient to discuss therapy options, weighing all available data regarding the drugs risk/reward profile?

In the real world, somewhere the FDA does not reside, there are times when clinical data offers conflicting conclusions.  In cases such as these the decision to use a particular therapy option should be left to the patient and physician, a decision should not be forced upon them arbitrarily by the FDA. This is particularly true for life threatening conditions such as breast cancer where even a few extra months added to the patient’s life expectancy is priceless.

This decision by the FDA is just further evidence that the agency has lost all touch with reality and has strayed from their stated mission. Rather than promote innovation and more therapy options the agency is actively stifling progress and preventing new therapy options from reaching patients. Sadly, the agency has no compassion for the patients and their families who suffer most from their actions. Frankly Ms. Woodcock and her co-workers at the FDA should be ashamed of themselves as their decisions are doing more than grinding innovation to a halt, they are filling coffins.