American Cancer Patients Deserve Chance for Lifesaving Treatments, but FDA Bureaucrats Stand in the Way

Every few months, a young 19-year-old woman from South Carolina boards a plane to London. She isn’t going sightseeing. She’s going to get her next dose of a cancer treatment that was invented in the United States, developed by an American company, and credited by her doctors with clearing a brain tumor other surgeons had refused to touch.She was diagnosed with glioblastoma at 16. It is the most common and most lethal brain cancer, the disease that killed Senator John McCain and Beau Biden. Her tumor came back so aggressively after her first surgery that doctors stopped operating. This was a death sentence.Yet one surgeon at the University of California, Los Angeles, agreed to perform the invasive surgery.Afterward she began a personalized immunotherapy made from her own tumor tissue and her own immune cells. Today her scans are clear, and she’s in college.Her family has health insurance, but they must pay for every flight and every dose out of pocket, with help from money raised from strangers online through GoFundMe.Why London? Because in Britain, a licensed physician can prescribe a promising treatment that for no rational reason has not been approved even on a limited and trial basis in America.Today there are dozens of promising drugs and therapies for multiple forms of horrific and crippling diseases: cancer, Alzheimer’s, multiple sclerosis, Parkinson’s, and diabetes, to name a few. Patients are literally dying waiting for the chance to use these treatments on an experimental basis. At the very bare minimum, they give suffering patients hope. But not in America. So much for “my body, my choice.”Why not let the patient, not Food and Drug Administration regulators, decide the most important decision of her life: how to stay alive?This is a cruel way for America to make health treatment decisions. I have no idea whether this particular cancer treatment really works, but in the case of a deadly disease, why not let patients try whatever alternative treatments they want? Isn’t it sad that in the land of the free, individuals have fewer treatment choices than most other nations in the world?By taking an experimental drug or treatment, these disease sufferers are being thrown a potential lifeline while also advancing the medical discovery process by acting as test cases. This is doing future patients a favor.President Trump has signed “right to try” laws, but the FDA remains an impediment. The waiting times to get approved are long, which means the tumors in millions of patients get larger. The risk-averse FDA seems wedded to its old way of doing business, with interminable testing in clinical trials while patients die waiting.There are three steps the FDA and the White House can take to help expand right-to-try and avoid often-fatal bureaucratic delays.First, for rare diseases, adopt a test of “plausible success.” If there is compelling evidence that a treatment COULD work, let patients try it.Second, expand “compassionate use.” A physician treating a patient with a terminal diagnosis should be able to prescribe a promising investigational therapy with the patient’s informed consent. The doctor would notify the FDA rather than ask its permission and drown in paperwork.Third, if a drug or treatment is approved in a developed nation, allow patients in the U.S. to use it with a different designation than “FDA approved.” This leaves the decision of whether to try the drug up to the patient, not the bureaucrat.Sometimes in medicine, the best and often most unexpected results come from the trial-and-error process.It’s a sad and cruel development that Europeans and South Americans can gain access to the latest breakthroughs in medicines while Americans can’t. Rich families can afford the costs of flying across the world to receive these treatments, but middle-class and poor families often can’t.What makes this predicament doubly foolish and inhumane is that many of these experimental treatments were developed in America.The Trump administration has an opportunity to show that “Make America Healthy Again” means letting American patients use American breakthroughs at home. The pathway has been announced. The president has already shown he cares about patients like this young woman. Now the FDA and Department of Health and Human Services have to deliver.No American should have to buy a plane ticket to London to get an American cure.Creators.com

American Cancer Patients Deserve Chance for Lifesaving Treatments, but FDA Bureaucrats Stand in the Way

American Cancer Patients Deserve Chance for Lifesaving Treatments, but FDA Bureaucrats Stand in the Way

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