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A new osteoporosis drug that’s “better” than an existing option? How this misleading message reached consumers and how it could have been avoided

A new osteoporosis drug that’s “better” than an existing option? How this misleading message reached consumers and how it could have been avoided

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Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.

When HealthDay ran a story last week claiming in the lead sentence that “An experimental drug appears to reduce the risk of bone fractures in postmenopausal women with osteoporosis better than a placebo and the currently available drug,” our reviewers were perplexed.

A woman with osteoporosis

The study that the story was based on gave women the new experimental drug (abaloparatide), an existing, approved osteoporosis drug teriparatide (Forteo), or a placebo. And it found that both of the drugs did indeed reduce the rate of vertebral fractures in these women compared with placebo after 18 months. However, the news story confusingly led with a comparison of the two drugs that was never intended to be made. Our reviewers wrote:

The research study was not powered to detect significant differences between abaloparatide and its currently-available competitor, Forteo (teriparatide). Thus, any juxtaposition of quantitative figures comparing the efficacy of the two drugs must be presented with important caveats, which we didn’t see emphasized enough in the news story.

The HealthDay story subheadline reads: “Abaloparatide appears to reduce fractures better than the current drug Forteo, researchers say.”

But in fact the researchers never said any such thing and explicitly warned against making such a comparison in the study itself.

Comparison of abaloparatide vs teriparatide for the primary efficacy end point was not part of the study objectives because the study would have required a sample size of approximately 22 000 per treatment group to provide 90% power to detect the treatment difference between abaloparatide (observed rate, 0.58%) and teriparatide (observed rate, 0.84%) based on our study results.

Where did this misinformation come from? It wasn’t the JAMA news release

We’ve noted in the past that misleading claims in health news stories sometimes are sparked by an overzealous news release. But that doesn’t seem to be the case here. While our review of the companion JAMA news release wished for more information on costs and potential conflicts of interest, our reviewers thought the release did “a wonderful and economical job summarizing the benefits of the drugs being studied.” They didn’t comment on any misleading comparisons because the news release didn’t make them; it stuck to the study’s primary outcome, the comparison of abaloparatide with placebo. (A news release put out by the company that makes abaloparatide — Radius Health, Inc. — also avoided any mention of Forteo.)

So does that mean the JAMA news release is totally off the hook here?

The reviewers of the HealthDay story weren’t prepared to go that far. They wondered whether the release “could have helped reporters by making a clear, unambiguous statement regarding the purpose of the study and its limitations.” They thought it was reasonable to anticipate that a busy reporter might misconstrue the findings as a comparison of the two drugs when it was not. In hindsight, they said, “it seems that the news release would have done well to emphasize this key nuance.”

News release writers can help ‘redirect readers back on course’ 

Of course we have no way of knowing whether the HealthDay reporter relied on or even saw the JAMA news release. (Neither HealthDay nor JAMA responded to an email requesting comment.) But considering how things played out, Earle Holland, a former senior science and medical communications officer at Ohio State University who was not involved in either review, said that JAMA could have taken some pre-emptive action to avoid foreseeable miscommunication. “Yes, release writers should remember that their readers may stray off the path they’re offering and the release should provide the kinds of information that redirect readers back on course. In this case, a simple sentence warning about comparing the two drugs in question would have helped.”

He added, however, that “the larger obligation rests with the reporter to get the story right, and in this case, comparing the two drugs for efficacy was not what the research was about. Saying that the release writer in this case is responsible for the misstatements of the journalist is suggesting that the journalist’s role is only to regurgitate what the release had offered, which we know is not what we want reporters to do.”

Bill Heisel, one of the reviewers of the JAMA news release, agreed that the onus rests more with reporters in cases like this.

Studies are incredibly complex, and if journals included every caveat and potential tripwire in a news release, the releases would be nearly as long as the studies and largely ignored. That’s one of the reasons we have the 10 criteria, to provide some essentials that every story/release should have. I suppose we could lump this under “quality of the evidence,” but I think that the release is clear enough that the focus is on abaloparatide.

While I agree with both Heisel and Holland, I sympathize with reporters who may inadvertently misstate the results of a study like this. It was only through many years of on the job training that I learned how to decipher the complicated jargon of medical studies and when to ignore results that seemed compelling. I wonder if my younger self might also have fallen into the trap that snared the HealthDay reporter.

Embracing a broader view of what news releases should tell readers

Our news release reviews are meant to encourage public relations professionals to expand the scope of their releases and address areas that they might not have previously considered — things such as costs, harms, and study limitations. We think that’s an important step toward improving the flow of information that ultimately reaches consumers.

As Holland observes, everyone has a part to play in keeping the health news stream running clear.

“Journal papers are usually long and detailed. Journalists’ stories are, most often, short and general. The obligation is to provide the public with accurate, interesting information and all the players – researchers, release writers and journalists – need to take their role seriously.”

The post A new osteoporosis drug that’s “better” than an existing option? How this misleading message reached consumers and how it could have been avoided appeared first on HealthNewsReview.org.

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Updated: August 31, 2016 — 2:00 pm

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