If a new prescription drug has not been proven more effective than similar medications, the label should make that clear, a group of researchers asserted in the New England Journal of Medicine this past week.
This comparative effectiveness data is just as important as information regarding the risks and benefits of a drug or device, according to Dr. Randall Stafford of Stanford University and colleagues.
A U.S. Food and Drug Administration requirement for label information would allow patients, physicians, and insurers to better judge whether a drug is simply a "me-too" product or a real advance, they wrote in an online perspective article.
New technologies, including drugs and devices, are a major factor in the rise of health care expenditures, which have grown by an estimated 71 percent since 2000, they said.
"The problem is that the public, including physicians, often view FDA approval as constituting more than it does," Stafford said. "There's an inherent tendency for physicians and patients to want the newest thing and to assume that newer and more expensive means better, although this is often not the case."
In addition to battling cost increases, a mandate for more detailed labeling would spur comparative effectiveness studies by the manufacturers, they said.
Currently, manufacturers are hesitant to conduct these studies because they require larger sample sizes, are more expensive, and increase the risk of producing unfavorable findings, the researchers said.
"Drug and device manufacturers benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other," Stafford said.
The researchers argued that "placebo-controlled trials that are not supplemented by active-comparator trials leave clinicians, patients, and payers in the dark, providing no guidance on a new product's advantages or disadvantages relative to existing products."
Using the example of a hypothetical new calcium channel blocker, they said a statement on the updated labeling might read: "Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class."
Comparative Drug Labels Face Challenges
They acknowledged that there are some obstacles to their idea.
Some might argue that comparative effectiveness falls outside the FDA's expertise, although they said adding more detailed information would be "consistent with the FDA's function as a public health agency."
In addition, they said, physicians and consumers may pay little attention to the new labeling. Defining drug classes can be difficult, and a drug may have multiple indications or may be superior to only some of the other drugs in its class.
"Such problems seem solvable, however, and only increase the value of indicating in the labeling exactly what remains to be determined," they said.
Stafford and his colleagues did not offer solutions to these potential problems.