There’s so much to like about this news release. In particular, it does a wonderful and economical job summarizing the benefits of the drugs being studied. It provides the numbers in both absolute and relative terms, for example. But it skimps on some of the details, chiefly the costs of the drugs, that the funder of the study makes one of the drugs in question, and whether the drugs are experimental or on the market.
Osteoporosis is a well-known risk factor for fracture, especially among older women. It can also be screened for with x-rays that measure bone density. A number of different treatments exist for individuals with osteoporosis and this news release presents data from a published study in JAMA.
For most individuals with osteoporosis, calcium and vitamin D supplements are recommended if dietary consumption isn’t adequate. First-line medications to decrease fracture risk is a group called the bisphosphonates. These medicines have been around for several decades and are usually taken by mouth on a weekly basis or by injection once a year. For individuals who are at particularly high risk, including those who have had a fracture while taking a bisphosphonate, second-line therapy is considered. These medicines include teriparatides that are given as a daily injection under the skin. The current study compares a new version of this class of drug, abaloparatide, to placebo and teriparatide. As a related editorial highlights, there are a number of effective medicines to prevent fractures in those with osteoporosis and they are probably under-used. For most individuals, use of existing oral medicines should be the focus of initial treatment. The current study focuses on giving patients who didn’t respond to the initial therapy or other high risk individuals another option.
There is no discussion of costs in the release. At a minimum it could have mentioned the cost of the existing FDA-approved comparator drug.
High in the release, the benefits of the drugs being studied and the placebo being compared are quantified clearly in both relative and absolute terms. Readers can see clearly that we are talking about quite a small group of people who saw benefits from either drug compared to the rather large group of women who were studied.
Most of the data presented was absolute risk which was excellent. This shows the benefit as well as the fact that most patients didn’t have a fracture regardless of which treatment was given.
The release says that there were no significant differences in harms seen between the drugs and the placebo without describing all the side effects. But it also mentions that hypercalcemia (elevated calcium level) was lower with the new agent compared to the existing comparator drug. While this was not explained in depth, we’ll give the release the benefit of the doubt for this brief mention of harms.
The story does a nice, succinct job explaining how the study was constructed, how many people participated, and other important details.
There is no disease mongering in the release.
To its credit the release quotes two people not associated with the study from an accompanying editorial and explains that the study was funded by Radius Health. But it does not make it clear whether Radius Health is involved in making an osteoporosis drug. Instead, the release directs readers to the full study (which is behind a firewall and available only to journal subscribers) for information on financial disclosures. The disclosure shows that several of the researchers, notably Paul Miller, MD, the corresponding author noted in the release, is a member of the scientific advisory board for Radius Health and several other pharmaceutical companies, and received research grants from Radius Health and a dozen other pharmaceutical sponsors. We think this information was important enough to include in the release itself.
The study itself was a comparison of two drugs and a placebo. The release explains that. The only thing that would have been better than this would have been an explanation of other ways the condition is treated.
This treatment is often viewed as a second-line one because it involves the inconvenience of injections under the skin. For most individuals, there are simpler oral treatments that are effective and have a long track record. The treatments studied here are for those with higher risks, especially those who did not respond to or did not tolerate the existing therapy.
The release does not make it clear whether the drugs being studied are on the market.
The release does not make the novelty of the findings clear. In the second paragraph, the piece discusses how this medicine works and that the study is comparing a new medicine with one already available. But what isn’t stated is why we need a new medicine. Isn’t the existing one good enough?
There is no unjustifiable language in the release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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