The news story focuses on an announcement from Johnson & Johnson that one of its drugs, Stelara, is effective at treating moderate-to-severe ulcerative colitis (UC). The story does make note of potential harms, and points out other treatments on the market to treat the disease.
However, the story does not make clear how well the treatment works or how much it costs. There was also no information about how or where these research findings were presented, nor was there any input from independent experts. It is not much more than a rewrite of the news release.
Relying solely on a pharmaceutical company for information about its products means that a news story is little more than a news release. In this case, the relevant news release actually provided significantly more information.
Costs are not addressed. This is problematic given that Stelara is already on the market for use in treating other medical conditions — and it can cost thousands of dollars. The story also doesn’t make clear that patients in the relevant trials received only a single dose (at one of two different dosages) — which is an important factor when considering cost.
The story notes that either dosage of Stelara “showed clinical remission in significantly more patients, compared with those on placebo, after eight weeks.” But what does that mean? One percent more of patients? Ninety-nine percent more of patients? The story notes that the patients in this study had not responded to available treatment options, and also states that “More than half of UC patients have not experienced remission with currently available treatment options.” But the story fails to say what percentage of patients who received Stelara experienced remission. (According to a news release, the answer was 15.5 or 15.6 percent, depending on which dosage they received.)
The story notes that one patient who received Stelara died from “excessive bleeding” but that overall side effects were similar between Stelara and placebo patients. That’s enough to earn a satisfactory rating here. However, it was fairly glaring to discuss a patient dying without explaining whether or not it was thought that this death was attributed to the treatment or the underlying disease.
Also the story would have been stronger if it had noted that Stelara affects the immune system, and can cause a host of other significant side effects. The story doesn’t need to list every single risk, but a sentence addressing the risks would be worthwhile.
The story infers that the study design included placebo, but doesn’t explicitly state that it was a randomized study with placebo. It also doesn’t make clear that patients in the relevant trials received only a single dose.
The story does not incorporate input from anyone not associated with the company or the study in question.
The story does note other UC treatment options, and notes that the patients in the study had not responded to those treatments.
The story notes that Stelara is already on the market. However, it’s not clear whether Stelara could currently be prescribed “off label” to patients suffering from UC. Nor is it clear whether the “late-stage” trial is still ongoing or has been completed. Is there a pathway to FDA approval? If so, what might the timeframe be?
The complexity of the drug approval process is such that news reports should help the public understand that this use of the drug is still experimental. that although the drug may be used “off-label,” it is not clear whether the company is seeking to broaden the FDA-approved indications or drum up interest among clinician researchers to design their own clinical trials.
The findings appear to be the first large-scale trial results assessing the effect of Stelara on chronic moderate-to-severe UC. That’s not explicitly stated, but it is sufficiently inferred to give this a satisfactory rating.
The release appears to be drawn almost entirely from a news release (including a slightly paraphrased quote from a researcher involved with the study). The only departure from the release that we could find was a reference to other, currently available treatments for UC.
The news story focuses on an announcement from Johnson & Johnson that one of its drugs, Stelara, is effective at treating moderate-to-severe ulcerative colitis (UC). The story does make note of potential harms, and points out other treatments on the market to treat the disease.
However, the story does not make clear how well the treatment works –nor how much it costs. There was also no information about how or where these research findings were presented, nor was there any input from independent experts. It is not much more than a rewrite of the news release, which is emerging as a pattern in our review of Reuters stories.
Relying solely on a pharmaceutical company for information about its products means that a news story is little more than a news release. In this case, the relevant news release actually provided significantly more information.
Costs are not addressed. This is problematic given that Stelara is already on the market for use in treating other medical conditions — and it can cost thousands of dollars. The story also doesn’t make clear that patients in the relevant trials received only a single dose (at one of two different dosages) — which is an important factor when considering cost.
The story notes that either dosage of Stelara “showed clinical remission in significantly more patients, compared with those on placebo, after eight weeks.” But what does that mean? One percent more of patients? Ninety-nine percent more of patients? The story notes that the patients in this study had not responded to available treatment options, and also states that “More than half of UC patients have not experienced remission with currently available treatment options.” But the story fails to say what percentage of patients who received Stelara experienced remission. (According to a news release, the answer was 15.5 or 15.6 percent, depending on which dosage they received.)
The story notes that one patient who received Stelara died from “excessive bleeding” but that overall side effects were similar between Stelara and placebo patients. That’s enough to earn a satisfactory rating here. However, it was fairly glaring to discuss a patient dying without explaining whether or not it was thought that this death was attributed to the treatment or the underlying disease.
Also the story would have been stronger if it had noted that Stelara affects the immune system, and can cause a host of other significant side effects. The story doesn’t need to list every single risk, but a sentence addressing the risks would be worthwhile.
The story infers that the study design included placebo, but doesn’t explicitly state that it was a randomized study with placebo. It also doesn’t make clear that patients in the relevant trials received only a single dose.
The story does not incorporate input from anyone not associated with the company or the study in question.
The story does note other UC treatment options, and notes that the patients in the study had not responded to those treatments.
The story notes that Stelara is already on the market. However, it’s not clear whether Stelara could currently be prescribed “off label” to patients suffering from UC. Nor is it clear whether the “late-stage” trial is still ongoing or has been completed. Is there a pathway to FDA approval? If so, what might the timeframe be?
The complexity of the drug approval process is such that news reports should help the public understand that this use of the drug is still experimental. that although the drug may be used “off-label,” it is not clear whether the company is seeking to broaden the FDA-approved indications or drum up interest among clinician researchers to design their own clinical trials.
The findings appear to be the first large-scale trial results assessing the effect of Stelara on chronic moderate-to-severe UC. That’s not explicitly stated, but it is sufficiently inferred to give this a satisfactory rating.
The release appears to be drawn almost entirely from a news release (including a slightly paraphrased quote from a researcher involved with the study). The only departure from the release that we could find was a reference to other, currently available treatments for UC.
Systematic, Criteria-Driven
Excelente conversación entre @garyschwitzer de @HealthNewsRevu y @marynmck sobre exageración y #COVID19 en el excelente MOOC de @utknightcenter. Vale la pena verlo. https://www.youtube.com/watch?v=SkgXiPojtg4&feature=youtu.be
Words of real wisdom, as usual @garyschwitzer
And: “There were no details, charts, graphs, numbers, nothing published in a journal."
#Pharma chairman:“If you don’t put out data people will say why are you withholding the data?”
Well, yes, that is exactly what people are asking. https://twitter.com/garyschwitzer/status/1264572399523180548
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