This WebMD story offers an interesting approach to covering a clinical trial for a new arthritis drug. It provides many more numbers than the typical story but very little commentary, no cost information, no analysis of the quality of the evidence, and no explanation of how this drug fits into the bigger picture of arthritis treatment.
In the hunt for a better arthritis drug researchers, and reporters, have to take care to present the evidence clearly and in context. We wish more stories would include this many numbers to back up information about purported benefits and harms, but stories also need to help readers understand what the numbers mean. That’s where more analysis and strong, independent voices are crucial.
The story does not discuss costs, which is a shame. Arthritis is a chronic condition, meaning that any drug that gives people significant relief likley will become a lifelong medication. Even if a per-pill cost is low, the cost per year can be huge. Without this information, it is difficult to gauge the true value of the drug.
As with the harms, the story provides a long list of comparisons in relative terms to tout the benefits of the drug. This is more helfpul than most stories, but the story could have done a better job by providing some numbers in absolute terms. The first comparison, for example, says, "67% had at least 20% fewer arthritis symptoms, compared to 35% of patients getting a placebo." It’s hard to know how big of a benefit this really is. We tried to do the math using the number of people in the study and quickly realized that without the number of symptoms, there is no way to calculate the true size of the benefit here.
The story provides more quantification of potential harms than most stories we review. It provides a point by point breakdown of the harms in the same way it breaks down the benefits. It also flags a potentially huge Achilles heel for the drug. "There’s at least one theoretical concern about R788. Normally, the Syk enzyme helps suppress tumors. Women with breast tumors have low levels of Syk. It’s not clear whether long-term use of R788 will increase cancer risk; longer-term clinical trials will have to evaluate this risk." This is more than a theoretical concern. Inceased cancer risk is one of the big reasons that drugs end up being pulled from the market after approval.
The extent of the evaluation here is describing the scope of the study: "457 patients with active rheumatoid arthritis despite methotrexate treatment received R788 or placebo for six months." Later the story says, "For now, R788 looks very promising, the researchers report." The story needed more analysis of why the results look promising and what may make the results hard to replicate in a clinical setting. The company itself has admitted in the past that the drug failed to show any real beneift, but there was no discussion of that here.
There are no independent sources in this story and, indeed, no named sources quoted. High in the story, it says "Now Harvard researcher Michael E. Weinblatt, MD, reports results from a phase II clinical trial," giving the imprimature of independent, academic reserach. But the story includes this helpful paragraph at the end. "Rigel funded the study, and three of the study’s six authors are Rigel employees. Weinblatt reports receiving grants, fees, or honoraria from a number of drug and biomedical companies, including Rigel."
The story drops readers into this supposed battle between this new drug and methotrexate, but it does not explain why these two drugs are being compared. Nor does it explain, as HealthDay does, that this drug is part of a new class of drugs in various stages of development.
The story says up high that results from "a pilot study" showed that the drug was promising in reducing the symptoms of rheumatoid arthritis. It then says, "Now Harvard researcher Michael E. Weinblatt, MD, reports results from a phase II clinical trial," making it clear that the drug is not currently available.
The lead of the story says, "An experimental rheumatoid arthritis treatment helps two-thirds of patients getting too little relief from methotrexate." But the story itself fails to explain how these two drugs interact, if at all. If this drug is truly novel, is it a replacement for the other drug or an enhancement? Have other drugs been tested in this same vein? Are there competitors in trials, too?
The story reads a little like a news release, but we could not find a news release that contained this content.
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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