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
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
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like