Note to our followers: Our nearly 13-year run of daily publication of new content on HealthNewsReview.org comes to a close at the end of 2018. Publisher Gary Schwitzer and other contributors may post new articles periodically. But all of the 6,000+ articles we have published contain lessons to help you improve your critical thinking about health care interventions. And those will be still be alive on the site for a couple of years.
Read Original Story

Reuters once again rehashes drug company news release

Rating

2 Star

Categories

J&J's Stelara succeeds in chronic bowel disease study

Our Review Summary

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.

 

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.)

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.

Does the story commit disease-mongering?

Satisfactory

No disease mongering here.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story does not incorporate input from anyone not associated with the company or the study in question.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does note other UC treatment options, and notes that the patients in the study had not responded to those treatments.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story establish the true novelty of the approach?

Satisfactory

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.

Does the story appear to rely solely or largely on a news release?

Not Satisfactory

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.

Total Score: 4 of 10 Satisfactory

Comments

We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.

We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.