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FDA Overcaution Is Costing Lives—but Lifesaving Reform Is Possible

November 27, 2018

November 27, 2018

Phoenix—The delays caused by the U.S. Food and Drug Administration’s (FDA) risk-averse approach to drug approvals can be harmful—and even deadly—to patients. But in his new report, Goldwater Institute National Investigative Reporter Mark Flatten explains that times may be changing when it comes to approving potentially lifesaving treatments.

Flatten’s Studied to Death: FDA Overcaution Brings Deadly Consequences explores the defects in the FDA’s drug approval process and looks ahead to some of the options gaining traction to restore the FDA to its intended mission. “The FDA exists to approve safe and effective treatments as quickly and efficiently as possible, but overcaution at the FDA is literally killing people,” Flatten said. “This is true for lifesaving treatments that can cure deadly diseases, as well as for new medications to treat chronic conditions like heart disease and diabetes that could save millions of lives and billions of dollars.”

One of the simplest examples of how the FDA’s bureaucracy is harming people is one of the most common drugs: aspirin. In his report, Flatten delineates the long history of FDA unwillingness to recognize the heart benefits of aspirin, continuing through the present. The death toll is real. It took five years for the FDA to accept aspirin’s benefits in preventing a second heart attack, despite overwhelming evidence. That delay alone accounted for a quarter-million deaths, if the agency’s own estimates are accurate. Even today, the FDA refuses to recognize the benefits of aspirin in preventing a first heart attack, even though the U.S. Preventive Services Task Force (USPSTF) and the American Heart Association support this finding. The USPSTF also recommends daily aspirin use for certain patients to help prevent colorectal cancer, yet another benefit the FDA refuses to accept.

Fortunately, the passage of federal Right to Try legislation—championed by the Goldwater Institute—is ushering in a new era, one in which the public and politicians recognize that the quest for absolute certainty carries deadly consequences. “Right to Try makes it easier for terminally ill patients to seek treatments that were otherwise unavailable to them, but this vital reform is just one step on the way to fixing a fundamentally broken approval system,” Flatten said.

Flatten outlines several additional reform proposals that could make new treatments available sooner to patients—and at a lower cost—while letting doctors and patients weigh risks and benefits. Conditional approval of specific treatments, international reciprocity (giving the FDA a window to approve or reject treatments already approved in certain designated countries), and allowing drug manufacturers to communicate with doctors regarding off-label benefits of a drug would all be avenues to give patients and their doctors greater flexibility in the treatment process. Flatten said, “these reform proposals all have the same basic purpose: to expand the arsenal of safe and effective drugs so that patients and their doctors can determine for themselves the best way to save and improve their lives.”

Read the full investigative report here.


About the Goldwater Institute

The Goldwater Institute drives results by working daily in courts, legislatures and communities to defend and strengthen the freedom guaranteed to all Americans in the constitutions of the United States and all 50 states. With the blessing of its namesake, the Goldwater Institute opened in 1988. Its early years focused on defending liberty in Barry Goldwater’s home state of Arizona. Today, the Goldwater Institute is a national leader for constitutionally limited government respected by the left and right for its adherence to principle and real-world impact. No less a liberal icon than the New York Times calls the Goldwater Institute a “watchdog for conservative ideals” that plays an “outsize role” in American political life.



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