Protecting Us To Death: The Food and Drug Administration is determined to protect your life -- even if it kills you.
Just ask
Edie Bacon, a mother of five from Massachusetts.
Edie is afflicted with metastatic soft tissue sarcoma, a very rare form of cancer. In the Wall Street Journal, she explains that "every oncologist in the civilized world knows I'm a goner if I don't get lucky. A few thousand cases are diagnosed each year; an equal number die. There's no cure. For about a third of us chemotherapy can 'buy some time,' but at a terrible price. Generally, regular surgery is the way to stay alive. The cancer grows slowly, and the tumors can be 'resected' as they appear. Eventually, you have so many that surgery is no longer possible."
Johnson & Johnson has a new drug which may offer Edie a fighting chance at living. The drug, ET 743, has "been approved by the FDA for trials in cancer patients who have failed other therapies," Edie writes. "It's been given to hundreds of patients in U.S. clinical trials over the past few years. It's been shown to be safe. It's the only drug in the world that has had significant success with sarcoma patients."
But the FDA is standing between Edie and what may be her last hope. She's physically and financially incapable of making weekly trips to Texas for the FDA's six-month clinical trial, and the FDA's myriad of cumbersome rules seriously jeopardizes approval of ET 743 should Johnson & Johnson provide it to someone outside of the clinical trial.
Edie says that before she's allowed the have the drug, the FDA want's "proof" that it works. But by the time the FDA has its proof, she will be dead. FDA red tape ensures that "the life of an individual patient has no importance whatsoever," Edie concludes. "Without ET 743, I'm a dead woman walking. Five kids are going to wonder why they're left without a mother."
The case of Edie Bacon offers a hard lesson: socialism is hazardous to your health.
