Gary Schwitzer • HealthNewsReview.org • Publisher
Why does this Matter?
- Sometimes news stories report on things as if they were available at your corner drug store, when, in fact, they may be years away from even coming on the market. It’s important for you to know that there may be a lot of marketing hype that suggests that something is well-studied and ready for use.
- Perhaps something is approved in Europe, but not in the U.S. That should raise questions about why it hasn’t been submitted for approval in the U.S. yet, or why it hasn’t gained approval yet.
- Early human trials may not be large enough to show, or may not be primarily designed to show, how well something works. Some early studies focus on safety, not on how well something works.
- Whenever you hear a prediction about something “expected to be approved by the FDA” in a certain time period, take it with a grain of salt. It doesn’t get approved until it gets approved. Ignore crystal ball predictions; they usually come from someone who stands to benefit.
- Finally, when you hear about new approaches – new devices or new operations – you should ask how widespread is the approach. No one wants to be patient number one with a new device or a new operation. And you should also wonder about whether all the personnel required to deliver the approach have been properly trained – and about whether there are enough trained personnel.
Thumbs Up Examples
The story says that the CT scanners used for this test are .all over the city. and included an estimate that in 2008 about 200,000 people around the country were scanned for calcium buildups in their coronary arteries.
This story provides good information about availability. The Xtag test is mainly used in hospitals and emergency rooms but can also be done in the primary care setting. Other important information on variability of the length of time needed to process the test, from hours to 1-2 days, was also provided.
The story explains that duodenal switch is “less common” and that “Duodenal switch is not a popular procedure.” In a 2008 study, it accounted for just 1 percent of weight-loss, or bariatric, surgeries done in the U.S., and 5 percent in Europe.”
Thumbs Down Examples
Although the story states that it has only been used in four patients, the procedure is only available in the context of a clinical trial at one institution, the Cleveland Clinic. The story should have stated this explicitly.
The story also states that the procedure may be approved within the year, but provides nothing in the way of justification for this claim.
The story only described this as a “new test.” Is it available? (Answer: No, it’s still experimental.)
Although the story does explain that this treatment is available and claims that the treatment is common on the West Coast but not in the Midwest, this is not sufficient information on availability. The story doesn’t give the reader any information on where to look for the treatment other than the owner of one facility.