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Researchers Say FDA Should be Cautious in Using

Sep 24, 2015

Researchers argue that the U.S. Food and Drug Administration (FDA) should avoid using words like "breakthrough" and "promising" when making announcements about new drugs.

The researchers contend that the public may not understand the FDA's particular usage. In ordinary use, "breakthrough" denotes an important advance, but for the FDA, a breakthrough is part of the drug review process. In the FDA review context, the word does not necessarily mean that a drug is effective or that it will help patients live longer, according to a new study by researchers at Dartmouth College's Geisel School of Medicine and Carnegie Mellon University, Live Science reports.

"Unless patients understand the FDA's usage of 'breakthrough,' they may have unwarranted confidence in the evidence supporting drug claims," researchers wrote in the September 21 issue of JAMA Internal Medicine.

The FDA designation "breakthrough therapy" is for a drug that meets specific criteria, including that the drug treats people with a "serious or life-threatening condition" and "may demonstrate substantial improvement over existing therapies." Breakthrough therapies undergo a faster FDA review process and are often approved more quickly, with the idea that additional evidence on the drug's effectiveness will come later.

Previous studies have shown that when drugs with the "breakthrough" designation are approved, the FDA news releases often use the word "breakthrough," and about half of these releases also use the word "promising."

For their study, the researchers surveyed about 600 American adults, asking them to read short descriptions of a hypothetical drug to treat lung cancer, Live Science reports. The descriptions were based on wording used in actual FDA press releases. One description presented just the facts, such as stating that half of participants in a study of the drug had their tumors shrink, and that this effect lasted about seven months. In a second description, the FDA called the medication a "breakthrough" drug, while a third called the drug "promising."

When reading only the facts, 10 percent of survey participants thought the drug was "very effective" at treating lung cancer. Their opinion of effectiveness increased to 22 to 25 percent when the words "promising" or "breakthrough" were used in the description, the study found. Forty-three percent of participants reading just the facts said the evidence supporting the drug was "strong." The percentage increased to 57 to 60 percent when "promising" or "breakthrough" were part of the description.

The researchers said the words "breakthrough” and "promising” increased belief in a drug's effectiveness and in the strength of the supporting evidence. They noted that the FDA is not required to use those words in its news releases, and they suggest that neutral terms in press releases "might help consumers make more accurate judgments about these drugs," according to Live Science.

In an editorial accompanying the article, Dr. Rita F. Redberg and Dr. Joseph S. Ross, editors of JAMA Internal Medicine, agreed that these terms might give patients "spurious hope” for a miracle cure. "Congress and the FDA should abandon the adoption of terminology like 'breakthrough' and focus on strengthening the evidentiary requirements for meaningful clinical data to ensure the promise of new drugs and devices," they wrote.

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