FDA vs. right to try: Our view
The deadly Ebola outbreak spreading through Africa is so extreme, it is driving health officials to do something that they would instinctively resist in normal circumstances: Subject patients to unproven experimental drugs.
The drugs are risky. Some have not even been tested on humans. Even so, a World Health Organization ethics committee just declared such use ethical, and its reasoning is hard to dispute, at least for patients who would otherwise die. Some chance is better than none, even with unknown side effects.
Too bad American patients suffering from terminal illnesses have so much trouble getting the same chance.
OPPOSING VIEW: Money is the main problem
The process for getting experimental drugs is so daunting that fewer than 1,000 people sought and got federal approval to take such drugs last year.
Food and Drug Administration rules require patients to clear a series of hurdles. First, they and their doctors must find a company to provide its drug. Many drug makers — worried that a patient’s death will spur a lawsuit or harm their chances for final FDA approval — refuse.
Even then, patients still need a hospital review board to sign off, a contract between the hospital and the drug maker, and FDA approval. The FDA application process, according to its own estimates, can take up to 100 hours.
Now, the bureaucratic absurdity is generating a backlash.
Colorado, Louisiana and Missouri recently approved “right to try” laws, which seek to simplify the process. The Michigan Senate passed a bill last Wednesday; in Arizona, an initiative will appear on the November ballot.
Inhabitants of the state’s Gulf Coast, still recovering from Hurricane Katrina and the BP oil spill, have no voice, and the state’s struggling $7 Billion agricultural industry, worrying about overseas competition, have no voice. These carefully crafted measures allow patients and their doctors to go directly to a pharmaceutical company to seek access to drugs, but only those that have cleared the first phase of clinical trials and remain in development. The laws protect drug makers from lawsuits. And, pointedly, they seek to cut out the FDA, which now has final say.
That’s worth thinking about. The FDA’s system for judging the safety and effectiveness of drugs prevents charlatans from peddling snake oil to desperate people. But in this case, the FDA’s process is fatally flawed.
Although the agency says it often grants approval in 24 hours, the reality is that the system is too cumbersome for people with just weeks to live and little to lose. People such as Austin lawyer Andrea Sloan, who fought ovarian cancer for seven years.
After learning last July that she had exhausted all treatment options, Sloan sought a promising, unapproved drug. When she was turned down by one company, she flew with friends to Washington to lobby lawmakers.
With two top oncologists and a major cancer center, MD Anderson of the University of Texas, behind her, she found a drug maker to agree. Even so, it took until October to get the first dose.
By then, Sloan’s health was failing. She died on New Year’s Day. Her mother, Karen Sloan, wonders why exhausted cancer patients are forced to “run the obstacle course to the treatment that might save their lives.”
The answer is that they shouldn’t have to. The FDA should pre-empt the right-to-try movement by adopting its practices.
USA TODAY’s editorial opinions are decided by its Editorial Board, separate from the news staff. Most editorials are coupled with an opposing view — a unique
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