This story on a pharma-funded study indicating that antibiotics may hold promise for people who suffer from irritable bowel syndrome (IBS) overplayed the study’s actual findings and spent too little time analyzing the evidence. This one did a better job than the AP story in identifying the conflicts of interest of the people it quoted, but that does not absolve it of the bigger failure: failing to find any independent sources to provide some much needed context and critical analysis.
Irritable bowel syndrome is a chronic condition that has perplexed researchers. Drug companies are hungry for an effective treatment so that they can tap into what appears to be a significant market — representing either 15% or 20% of the population, depending on whose numbers you believe. Regulators typically set a high bar for a drug to be marketed to patients for broad use, which is why the antibiotic treatment described is still under review and only available for off label use. Reporters should set a similarly high bar and not allow drug company hype or individual success stories sway them away from the hard data. Instead of a marketing-style headline such as “2 weeks of antibiotic therapy relieves IBS” — can’t you see that on an advertisement during a football game? — the story could have just as easily said, “Most people don’t see relief of symptoms after taking expensive antibiotics” – or that more than 30% of those taking a placebo did find relief.
This story made no mention of costs. This is a shame in a story that is essentially promoting off label use for a costly drug that is only approved for a very narrow range of treatments. The Associated Press story that we also reviewed estimated that the pills cost $21 a pop, resulting in a $910 price tag for a two week supply. Given that IBS sufferers may require long term treatment, this bill could grow exponentially.
When quantifying benefits, the story allows hype to take the place of hard data. The second quote in the story, from the lead researcher, who has just been paid by the drug company to conduct this study, says, “With the new antibiotic treatment, Pimentel tells WebMD, many participants ”say they are 80% improved, 90% improved, that kind of results.”” Note that phrase: “many participants.” Just how many? And what does 80% or 90% improved mean? What objective measure of this was made?
The story also glosses over the significant placebo response in comparison with the drug group response, reporting:
“Just 31.7%” ??? This is biased framing.
The main problem is that there was no explicit statement about presence or absence of side effects. Readers want to know, and since researchers have studied and reported on adverse effects, there should be an explicit mention in a news report. In this case, there was no difference in side effects between the drug group and the placebo group.
The story does an adequate job explaining how the research was done, and had appropriate caveats from an editorial author.
The story did not engage in disease-mongering and presented the information about the disease in a straightforward way. “The study looked only at those IBS patients with the non-constipation form, he tells WebMD. For those with this type of IBS, symptoms can include abdominal pain, bloating, and changes in bowel function such as diarrhea. IBS is considered a functional gastrointestinal disorder without a known physiologic cause, with the symptoms recurring and often worsened by stress. Existing treatment options — diet and lifestyle modification, psychological therapy, and other drugs — do not help all people with the condition.”
This is where the story excels in one way and fails in another. It excels by taking pains to point out the conflicts of interest of everyone it quotes. It nearly gives the lead author, Mark Pimentel,” a pass by calling him “director of the GI Motility Program at Cedars-Sinai Medical Center, Los Angeles, who led the clinical trial of the drug at Cedars” in the second paragraph and waiting until paragraph 14 to tell readers, “The studies were funded by Salix Pharmaceuticals Inc., which makes rifaximin. Pimentel serves as a consultant to Salix and serves on its scientific advisory board. He discovered the use of the antibiotic for IBS. Cedars-Sinai holds the patent and has licensed the rights to Salix.” It goes on to quote Jan Tack and says, “Tack has served as a scientific adviser to companies evaluating IBS drugs.” Its last source is Christine Frissora, of whom the story says, “Frissora reports research funding from Tioga Pharmaceuticals for a study of an IBS drug and serving on the speakers bureaus for Prometheus Therapeutics and Diagnostics, Salix Pharmaceuticals, and Takeda Pharmaceuticals North America.” See a pattern here? Where are the independent voices in the story?
So, for example, when Dr. Frissora says the findings “will probably encourage other doctors to try it, especially primary care doctors who may not [yet] know about this data” – why don’t we hear from an evidence-based primary care doc about whether he/she will change practice based on this info?
The story does not compare the antibiotic approach to existing alternatives. It says only, “Existing treatment options — diet and lifestyle modification, psychological therapy, and other drugs — do not help all people with the condition.” Well, neither did the drug being studied! And the story didn’t give any details about past research into antibiotic therapy for IBS.
The story says that rifaximin “is approved by the FDA only for traveler’s diarrhea and hepatic encephalopathy, a brain disorder caused by chronic liver failure.” And it interviews a physician who’s been using it off-label for the non-constipation form of IBS. But the story does not make clear how widely used it is.
The story does not establish the true novelty of this approach. It lists a bunch of existing treatment options that are all not antibiotics and then transitions to “With the new antibiotic treatment…” and later briefly mentions other antibiotics “which have produced mixed results for IBS patients.” We find this confusing. How much have other antibiotics have been tested in IBS? Why weren’t they listed among the “existing treatment options”?
The story does state that researchers chose rifaximin because it might perform better than other antibiotics. But, again, any precedent for, or track record with, antibiotic therapy for IBS is not clearly explained.
The story did not rely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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