Study Suggests Osteoporosis Drug Might Treat Loss of Bone in Jaw

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There’s no discussion of costs. Forteo at the doses described costs about $250/week. Given the severity of the osteonecrosis described in the letter of a single case, the costs are relatively nominal since the treatments were of fairly brief duration.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The benefits described in the clinical trial were not quantified or described in sufficient detail. It simply states that “greater healing” was noted in patients receiving Forteo. The exact meaning of the phrase is unclear and could leave readers with an overly optimistic impression of the value of Forteo in this group of patients.

The story provides an adequate amount of detail concerning the case report, noting the patient was pain-free after treatment. It should have noted however how long the patient was followed.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

In our opinion, the risks of Forteo are not described in sufficient detail. It does note that Forteo may prompt further spread of bone cancer, but what about the more common side effects? The Forteo prescribing information, for example, lists a number of more common side effects, and it includes a black box warning with a broader caution about bone cancer, concluding that this drug should only be prescribed for patients in whom the potential benefits outweigh the risks.

While this particular study observed no significant differences regarding adverse events, including no serious adverse events, the article should have noted, as the investigators do, that the study was too small to accurately assess safety. Absent such a discussion, the article might be read as implying a green light for safety.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

There’s a modest amount of information about the evidence, including the number of subjects in the randomized trial, the fact that it was randomized and placebo-controlled, the background therapy received, the patient population, the duration of therapy, and the one-year follow-up period.

That said, while Dr. D’Souza points out that this evidence is at the proof of concept stage, we think the article needed to clearly and prominently acknowledge how early this evidence is, or at least discuss the limitations of a very small trial and a single case study. There’s no discussion of why the totality of this evidence is limited, what we don’t know yet, and why future studies are needed to illuminate safety and efficacy of this drug in this application. It’s not sufficient to say that the FDA hasn’t approved this indication yet: it hasn’t approved it for a reason.

The NEJM editorial identifies several unanswered questions about the randomized trial, regarding, for instance, the durability of the effect and whether other less-expensive drugs also effective, and it establishes the need for furture trials with more subjects and longer durations. We think these important provisos should have been included in the story.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The article cites the editorial and one source who seems independent. It fails to mention that Forteo’s dad, Eli Lilly, provided financing for this study, and one author disclosed an additional financial relationship with Lilly.

More of the perspective from the editorial would’ve been a great asset to this article, as it provided a realistic appraisal of the study’s results.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The article notes that bone grafts are the most common treatment for the form of gum disease-related bone loss assessed in the small study. That, however, does not constitute a comparison or an acknowledgement that the pros and cons of Forteo relative to this existing treatment are unknown. Nor does it provide information about other alternatives, such as the existing therapies for osteonecrosis.