Gary Schwitzer • HealthNewsReview.org • Publisher
Why does this Matter?
- In health care, newer isn’t always better. In fact, sometimes it really isn’t even “newer”
- Many “new” treatments, tests, products or procedures are not really novel. A “new” drug may be another member of a well-established therapeutic class of drugs.
- Even if a drug is the first in a new class of drugs it may offer no more than the drugs that are widely available.
- Drug companies are very good at promoting their new drugs as “novel” in order to increase initial sales.
- Also realize that some claims about new drugs are claims made for uses that haven’t been approved by the FDA. Doctors are allowed to prescribe a drug for such an “off-label” use. But the FDA advises doctors in such circumstances that .they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”
- But our experience with this project so far shows that journalism does an awful job of discussing costs – getting the weakest grades of any of our ten criteria.
- One study recommended more careful monitoring of off-label uses that might waste money and harm patients.
- And some insurance plans will not reimburse the cost of drugs prescribed for “off-label” use.
- “New” medical devices may not be that novel, either. We reviewed a story on NBC about FDA approval of a new laser hair comb for baldness. NBC called it a .potential cure for baldness.” But the story failed to point out how such devices are approved by the FDA. Some new devices must only pass a test of “substantial equivalence” to products already on the market. The FDA lists 10 such products. So not only did the story fail to tell how well the device works, it failed to put the new idea into the context of existing alternatives.
- And if you think drug and device approval is less than a guarantee of novelty, consider that no one approves new surgical procedures.
- By focusing on one new idea, it may appear that it’s the only thing being researched in the field. Even a line about other approaches/research would help.
- It is incredibly rare that a study really is novel, appears out of nowhere. Where the new report is coming from is part of the context that is often missing. The “big” picture. This is hard to know unless the reporter finds a truly independent expert.
- Don’t forget about clinicaltrials.gov as a click-away source of information about other studies that are underway about a specific treatment or for a particular condition. It can be useful for providing context about something seemingly innovative.
- Another resource for assessing novelty is PubMed. You can put in a key word or two and pretty quickly establish whether something is absolutely unique and if not – how long it’s been around and studied.
- We repeat: newer isn’t always better in health care. And it may not really even be newer.
Thumbs Up Examples
The article makes clear that the tested treatment is widely used. It also explains that previous research has been done on this specific question, preventing readers from thinking the conclusions of this research are novel.
The story was clear that this was a new medication, though there are two other medications that are currently available.
The pipeline for effective lupus drugs has indeed been dry for quite a while. The article indicates that this is a novel product of genomic technology.
Thumbs Down Examples
This story reports on a lycopene supplement as though this was news. There are other lycopene supplements on the market.
The story failed to note the availability of another drug which has a similar mechanism of action. The lack of comment on the close relationship between a commercially available drug and the drug under study is a significant lapse.
A competing WebMD story makes it clear at the top how unique this procedure is. This story does not make it clear at all.