The story describes a new method of administering an existing drug to a subset of patients in the early stages of a debilitating form of Multiple Sclerosis (MS). The story discusses why this method of delivery may be an improvement over existing immunosuppressant drug regimens for difficult-to-treat MS cases. And it explains why more information about risk and efficacy of the high-dose treatment is needed before it can be accepted for clinical use.
The story adequately describes the small, open-label, pilot-stage study of 9 MS patients. The story appropriately notes inclusion criteria for the study (i.e. patients in the early stages of aggressive MS) and cautions that the preliminary findings may not apply to other people with different subtypes of MS.
The suggestion by a study researcher that results of this study could lead to a cure for MS seems premature, especially given the small number of people involved and outcomes at 2 years; however, the story does note the limited information available for HiCy therapy and the need for future randomized controlled trials with a larger group of patients. The story mentions the harms of treatment typically seen in patients taking the pulsed dose of cyclophosphamide, as well as side effects seen in the small group of patients in the HiCy trial.
The cost of currently available low-dose, pulsed immune suppressing drugs could have been mentioned. It would be good to know if there would be a potential cost-saving for the patient with HiCy therapy. But the story does note the economics driving drug research and implications for the development of new treatments for people with difficult-to-treat chronic conditions.
Overall, though, this was a solid report.
The cost of currently available low-dose, pulsed immune suppressing drugs could have been mentioned. It would be good to know if there would be a potential cost-saving for the patient with HiCy therapy. The story does note the economics driving drug research and implications for the development of new treatments for people with difficult-to-treat chronic conditions.
The suggestion that results of this study could lead to a cure for MS seems premature, especially given the small number of people involved and outcomes at 2 years; however, the story does note the limited information available for HiCy and the need for future randomized controlled trials with a larger group of patients.
The story mentions the harms of treatment typically seen in patients taking the pulsed dose of cyclophosphamide, as well as side effects seen in the small group of patients in the HiCy trial. These included: nausea and hair loss and increased risk of infection. The story also mentioned that some patients’ symptoms became worse before they improved. Researchers do not currently know the long-term effects of this high-dose, concentrated drug regimen.
The story adequately describes the small, open-label, pilot-stage study of 9 MS patients and presents findings for the lay reader. The story appropriately notes inclusion criteria for the study (i.e. early stages of aggressive MS) and cautions that the preliminary findings may not apply to other people with different subtypes of MS. The story provides some data on study endpoints, i.e. brain lesions in 7 of 9 people improved and there was a statistically significant reduction in disability in most participants.
The story does not engage in disease mongering. The story includes U.S. prevalence data and describes different forms of MS, qualifying discussion of the novel treatment with a reminder that HiCy was only tested in very debilitated patients. As mentioned in the press release accompanying this story, the study included the "worst of the worst" MS patients.
The story includes interview with study authors and participants, as well as Dr. Richert, VP of research and clinical programs for MS Society, who puts the results of this study in perspective.
The story mentions other FDA-approved treatments for MS and compares the current use of longer-term pulsed intervals of cyclophosphamide with the higher-concentrated regimen–which lasted only 4 days and was less toxic. The story notes that this experimental delivery system was tested in people in the early stages of a particularly aggressive form of MS, and the treatment is not a long-term cure.
The story mentions that high-dose cyclophosphamide (generic name for Cytoxan, Neosar, Revimmune) (HiCy) is currently being studied via clinical trials, and at this time the concentrated form of the immunosuppressant drug is limited to people in the early stages of an aggressive form of MS. The story mentions that cyclophosphamide is already used in a different dosing regimen for treatment of MS. The high-dose regimen is under study and more information about risk and efficacy is needed before it can be accepted for clinical use.
The story describes the pros and cons of this new method of administering an existing drug to a subset of patients in the early stages of a particularly debilitating form of MS. The story discusses why this method of delivery may be an improvement over existing immunosuppressant drugs regimens for difficult-to-treat cases.
There is similar language in the press release and news story; however, there is also some independent reporting and the story includes a perspective (MS researcher Dr. Richert) other than those of the researchers and participants from the HiCy trials.
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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