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A Cruel FDA Rollercoaster Ride for Women Taking Avastin



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Can it get any worse than this? First you find out you have an incurable disease. Bad news. Then you find out there is a drug that may not cure you but at least keeps you alive. Great news. You take the drug and miraculously your disease is held in check. Miraculous news. Then the FDA tells you that despite your positive results, the drug does not work and they are pulling it off label. Nightmarish news.

However, as the drug is available for other diseases, you can still get the drug off label. Good news. But the drug costs between $56,000 and $96,000 per annum, and Medicare and private insurance companies often deny coverage for off-label prescription. Tough news. Maybe the drug company will make the drug available for free on a compassionate use basis. Hopeful news. But they can’t because they are afraid of corporate and personal liability. Sad news.

Then the drug company applies to the FDA for a hearing to review their earlier decision. Positive news. The FDA announces that a hearing will be held June 28–29 in Washington, D.C., at the FDA headquarters. Encouraging news. But no patients will be allowed to speak. Insulting news.

Such is the rollercoaster ride that the FDA has inflicted upon women with incurable metastatic breast cancer who are taking the drug Avastin. These extremely brave but desperately ill women fight from week to week to stay alive. But insensitive FDA bureaucrats have continued to torment these women with their endless vacillations as they try to defend the indefensible.

The FDA’s follies begin with the assumption that the drug on average does not justify the risks. For most patients, the risks are very manageable — and when compared to the alternative of death, a very easy decision to justify. While the benefits certainly vary widely, there is a group of women — among the estimated 17,500 women on this drug in the U.S. — who are doing remarkably well on the drug. I should know; my wife is one of them. The FDA knows that these women, the so-called “super-responders,” exist, but officially does not acknowledge them and so acts as if they do not. It is easier to act this way than to question whether the FDA made the right decision or whether its drug trials might not be as effective as they tell us they are.

Could it be that the FDA does not want these innocent women to tell their stories in front of the hearing on Avastin? Why is it that murderers on death row have multiple rights of appeal that often run for five or ten years but these women cannot speak at what is in effect their final sentencing? Without Avastin, many of these women will die within the next 12 to 24 months. Has the FDA not inflicted sufficient indignities on these women that it now needs to deny them their right to speak on top of already denying them their fundamental rights to life, liberty, and the pursuit of happiness?

Critics of Obamacare seemed over the top when they warned of “death” panels, rationing, and interference in medical-care choices. The Avastin case has all of this and more. The interference by government in the doctor/patient relationship is blatant here. Why must these women suffer further by having their individual rights trampled by a government trying to practice medicine by remote control? To deny a critically ill person medicine that could help is unconscionable; to remove it, literally, from the mouths of those already taking it is inhumane.

Americans should have freedom of access to medicines that they and their doctors believe can be beneficial. Pity the Avastin women who have neither choice in their medicines nor the right to protect their own lives. Shame on all of us, America. We need to the right thing and begin by grandfathering in the women currently on Avastin.

— Terrence D. Kalley lives in Michigan. His wife has been an Avastin patient for two years.



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