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.
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