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Doctors suggest that women hit pause button on osteoporosis drugs

Rating

3 Star

Doctors suggest that women hit pause button on osteoporosis drugs

Our Review Summary

This story about drug treatments for osteoporosis positions itself as a careful re-analysis of the benefits and harms of a class of drugs known as bisphosphonates. So we were surprised to find that this story suffers from some of the same deficiencies that typically plague boosterish puff pieces. Particularly problematic in this story is the lack of quantitative data. We learn that the use of bisphosphonate drugs is becoming more limited due to increasing awareness of frightening side effects, such as cancer and jaw necrosis. Yet there is no accounting in the story of how often these harms occur or how effective the drugs are for preventing fractures. There also were significant gaps in the coverage of costs and in the disclosure of potential financial conflicts. Despite its considerable shortcomings, the story gets credit for framing the issue in an appropriately cautious way and for soliciting a variety of expert perspectives. Readers should come away from the story with a generally accurate, if incomplete, understanding of the issue.

 

Why This Matters

There is evidence that long-term use of bisphosphonates can increase the risk for a number of rare but potentially serious adverse effects. How long women should continue taking these drugs is an open question that researchers urgently need to address.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs, and we think there always should be.

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

Not Satisfactory

The story suggests that there are women who will clearly benefit from taking bisphosphonates and for whom these benefits will outweigh the harms. However, the story never provides any detailed accounting of how often these benefits occur. We are assured by one of the experts that a two- to five-year course of these drugs “saves fractures, pain, disability and life.” But surely this is the same thing doctors were saying until recently to the women who it turned out didn’t need these drugs and weren’t experiencing these benefits. To be credible, statements such as this need to be backed up with data on the absolute reduction in fractures seen in the treatment group compared with placebo. It would also be important to note whether the fractures prevented are in the long bones or the hip (which can be devastating for older women) or in the vertebrae (which are often asymptomatic and may not affect how a patient  lives her life).

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

Not Satisfactory

When the harms of a particular treatment are not critical to discuss at length, we sometimes let a story slide without going into too much detail on this issue. In this case, however, the story’s premise is that the harms of bisphosphonates are larger than was previously appreciated and may outweigh the benefits for many women. So we expected the story to provide some statistics about how often these serious adverse effects occur. The story fell short by using vague and subjective language to characterize these risks. Examples:

  • Jaw necrosis has been reported “in rare cases” according to the story, but we are never told what “rare” means. The story also underplayed the potentially catastrophic consequences of jaw necrosis by describing it rather mildly as a condition “in which the jaw bone begins to deteriorate.” It can be much worse than that.
  • We are told that women taking bisphosphonates have a “slightly higher” risk of esophageal cancer but receive no quantitative description of the risk.
  • We learn that long-term use of bisphosphonates has been associated with “rare and unusual” femur fractures–again without any language that characterizes the extent of the hazard.

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

Satisfactory

We think readers will come away from this story with a generally accurate, if incomplete, understanding of the role of bisphosphonates in osteoporosis treatment. So while there clearly were some critical deficiencies in this story’s handling of the evidence (which we flag in other sections of this review), we’ll award a satisfactory here to recognize the story’s appropriately skeptical approach to the topic overall. Its framing of the issue emphasized that the benefits of bisphosphonates are unlikely to outweigh the harms for many women at low to moderate risk of a fracture. And it acknowledged that there was little evidence to suggest that a “pause” in treatment, as advocated by some, would help prevent the serious problems that have been reported with long-term bisphosphonate use.  The story also put appropriate emphasis on the role of pharmaceutical marketing in creating a demand for treatment among women who probably won’t benefit from it.

Does the story commit disease-mongering?

Not Satisfactory

The story acknowledges that many women with modest bone loss are being treated with bisphosphonates and other osteoporosis drugs even though the benefits of these treatments may not outweigh the risks. The story also notes that the drug industry played a huge role in expanding the market for these drugs to women who probably don’t need them (a tale nicely chronicled in this 2009 piece by NPR). So it was odd, given this context, that the story let an aggressive claim by one of its sources go completely unchallenged at the end of the piece. The source says that  under-use of osteoporosis drugs “remains a bigger problem than overuse.” This is despite the source’s previous acknowledgment that most women with modest bone loss — a group that includes millions of women in the U.S., many of whom are being treated with bisphosphonates — probably do not need to be treated and yet are being unnecessarily exposed to the risks and costs of treatment. We think this statement smacks of disease-mongering.

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

Not Satisfactory

The story calls on multiple experts who provide important and valuable context for the story. We just wish the story had pointed out the potential financial conflicts that one of the quoted researchers — Dr. Richard Eastell — may have when commenting on osteoporosis treatments. Eastell disclosed more than a dozen commercial relationships in this recent NEJM study, many of them with companies that make drugs to treat osteoporosis.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions several other classes of drugs that may be used to treat osteoporosis in lieu of bisphosphonates. The story could have done a bit more to point out that these drugs also have known drawbacks that limit their use, but we don’t think a full discussion was necessary to fulfill the criterion.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story makes it clear that the osteoporosis drugs being discussed have, in most cases, been widely available for a number of years.

Does the story establish the true novelty of the approach?

Not Applicable

The novelty of these drugs is not really in question, so we’ll call this one not applicable.

Does the story appear to rely solely or largely on a news release?

Satisfactory

This story was clearly not based on a news release.

Total Score: 4 of 9 Satisfactory

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