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Drug for Irritable Bowel Achieves Goals in Trial


4 Star

Drug for Irritable Bowel Achieves Goals in Trial

Our Review Summary

This New York Times story about an experimental drug for irritable bowel syndrome (IBS) satisfied most of our criteria. Its few shortcomings, however, were significant and threw the overall story out of balance. First, the story reported on clinical trial results obtained directly from the manufacturer of the drug being tested prior to peer review or publication in a journal. The story should have cautioned readers about the lack of external scrutiny of the findings or the conflict of interest inherent in such a scenario. The story then compounded this problem by failing to obtain any independent perspective of its own about the research. The only outside comment the story solicits is from an expert who consults for the company. The result is a story with content that comes almost entirely from the drug manufacturer–not what readers expect to see in the pages of the New York Times.   


Why This Matters

There are few effective treatments for irritable bowel syndrome, and most of the treatments that are effective bring limited relief to a minority of patients. The prospect of a useful new therapy for this condition is excellent news for patients, but we need independent scrutiny of the research to make sure the results aren’t being overhyped.


Does the story adequately discuss the costs of the intervention?


The story notes that the new drug would likely cost "several dollars a day." We’ll call this satisfactory since we can’t know exactly how much this drug will cost, but we’d suggest that a cost-per-month metric would be a better way to quantify the costs of treatment. It would allow for easier comparison with other recurring costs like the cable or phone bill.

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


This story did a pretty good job with the statistics. Importantly, it provided the absolute percentage of patients who experienced benefits in each group according to the various assessments used in the study. The story tell us: "Fifty percent of those on the drug had a significant reduction in pain, compared to 37 percent for those on the placebo." Had the story used relative measures instead, it might have told us something along the lines of "…35% more patients treated with linaclotide experienced significant reductions in pain." We think the first description is a much more accurate and complete way to characterize the results.

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

The story tells us that 6% of patients dropped out of the study because of diarrhea, the main side effect of the new drug. We’ll call this enough for satisfactory, but we wish the story had also told us the total number of patients who dropped out of the study in the treatment group compared with the placebo group. This is a better measure how well patients in the intervention group were able to tolerate the drug. In addition, we think the story missed an opportunity to discuss the potential for serious adverse effects that couldn’t be assessed by this study. The story tells us at one point that another drug for IBS, Zelnorm, had to be pulled from the market because it might cause heart attacks and strokes. This was after Zelnrom was already approved by the FDA on the basis of studies similar to this one. The point is that some risks may only become apparent after a drug enters the market and is widely used by large groups of patients.The story had an obvious opening to discuss this but failed to rise to the occasion.  

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

Not Satisfactory

The story hit most of the issues we wanted to see addressed with respect to the study, including number of patients, the type of intervention, length of follow-up and outcomes measures. But it glossed over the fact that the study results appear to have come directly from the manufacturer of the drug being studied and not from a peer-reviewed journal or even the researchers who conducted the study. The drug manufacturer obviously has a strong incentive to present the results in the most positive possible light and avoid any critical analysis. It was incumbent on the story to provide some cautionary language about the preliminary nature of the findings and lack of peer review.  

Does the story commit disease-mongering?


Irritable bowel syndrome is a controversial diagnosis.  Some view it as a minor problem that has been medicalized by the drug industry to sell new medicines. However, there are clear criteria for identifying the condition, and it is now a generally accepted diagnosis.  The story captures some of this uncertainty when it says the condition is "poorly understood and somewhat vaguely defined." We don’t think this story is an example of disease-mongering.

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

Not Satisfactory

There was no mention of the fact that the study being reported on was conducted and funded by the manufacturer of the drug being tested. In addition, almost all of the information in this story came from the drug manufacturer or someone with ties to it. Examples:

  • Study results were provided by the manufacturer with no peer review.
  • An expert who consults for the manufacturer calls the drug a "one-stop-shop" for people with IBS. 
  • The CEO of the says his drug has a potential market of 10 million people.

We think this story could have benefited from an alternative perspective.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

This story mentioned opioids, laxatives, and the drug Amitiza as other potential treatments for IBS with constipation. But the story didn’t discuss the mainstays of treatment for IBS — exercise and dietary changes (along w/ stress management). It also didn’t mention many other treatments that have at least some evidence to support their use, including antidepressant drugs, fiber supplements, probiotics, anti-spasmodic drugs, and peppermint oil. In addition, there was also no discussion of how the benefits of the new experimental drug stack up against any of these alternatives.  

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


The story makes it clear that this is an experimental drug that is not yet approved by the FDA. It notes that the drug will have to succeed in another phase 3 trial before the manufacturer plans to submit an application for approval to the FDA. It doesn’t speculate inappropriately about when the drug is expected to be approved.

Does the story establish the true novelty of the approach?


The story could have mentioned the many other drugs that are in development for treatment of IBS, including one–prucalopride–which was recently approved in Europe. However, we don’t think this story oversold the novelty of the new treatment.

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


Since the story includes interviews with two experts — an IBS expert who consults for the drug manufacturer and the company CEO — we can be sure the study wasn’t based entirely on a press release.

Total Score: 7 of 10 Satisfactory


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