This story provides good background on these diseases and is very careful not to drag low-dose bisphosphonates into the fray. The story, however, neglects to address some aspects of the research that are critical to understanding what they mean. In short, as we’re fond of saying, not all studies are created equally.
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.
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.
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.
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.
The story does not engage in disease-mongering. While raising the connection between bisphosphonates and bone loss in the jaw, the article is careful to add qualifiers like “heavy use” and several mentions of “rare.” It states that the incidence is increasing in patients receiving bisphosphonates for osteoporosis, but it’s much rarer than the 5% incidence in patients receiving bisphosphonates during cancer treatment. The story also distinguishes between low-dose and high-dose brands of bisphosphonates.
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.
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.
It could’ve been more explicit about the drug’s current availability via prescription. We also don’t applaud the comment that Forteo is “not yet” approved for this indication. It could’ve been worded in a less presumptive manner.
The article explains that Forteo is not approved by the FDA for osteonecrosis or the form of gum disease assessed in the randomized study. It could have noted that previous studies have suggested that Forteo may be of value in the treatment of osteonecrosis.
The story does not appear to have relied on a press release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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