This release summarizes an investigational study on a ‘novel’ colonoscopy bowel preparation under development by a Massachusetts-based company. The release claims that the prep is a more palatable regimen that includes solid food bars and low-volume beverages. Researchers report that by the end of the Stage 2 clinical trial, the regimen was as safe and effective as two currently available colonoscopy prep formulations in cleaning out the colon, and, importantly, participating trial volunteers gave the preparation a high rating.
The release did a good job of describing the study and quantifying benefits. The existing preps that the novel formulation was compared against were never mentioned and that seems an important omission. The release also didn’t provide enough details about harms, or a ballpark cost estimate, which it seems reasonable to expect in almost all news releases.
The study was presented at the American College of Gastroenterology’s 2016 annual meeting.
The standard bowel preparation and prolonged fasting required to ensure a clean viewing field for the gastroentologist is daunting and has been suggested as a limiting factor in acceptance. For those approaching the magic age, Dave Barry’s 2009 article in the Miami Herald provides a humorous look at this screening procedure. But the reality is that colon cancer is the second leading cause of cancer death in the United States and individuals should have a discussion about the benefits and risks of the procedure. The US Preventive Services Task Force recommends screening for colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults, beginning at age 50 years and continuing until age 75 years.
Should the prep described in the release hold up throughout the clinical trial process, it may be welcomed by individuals facing a colonoscopy.
Although the prep is still moving through clinical trial stages, the anticipated cost of this new formulation will be front-of-mind among folks reading stories about it. The earlier this kind of information is offered the better.
The release provides a modest amount of information on the results of the study providing both percentages and actual numbers on the success and acceptability of the comparisons. We would have liked to have seen an acknowledgement that the sample size is rather small and while the percentages seem impressive, they may not be clinically or statistically significant.
While the text notes that individuals involved in the study experienced no “serious adverse effects,” it doesn’t define what “serious” means. The use of that adjective implies that participants may have experienced some side effects, however modest. And although this prep is too new to have gathered data over time about possible harms, the release claims it is as “safe” as some already available options. These standard preps are purgatives that often come with mild side effects such as stomach pain, nausea and syncope from induced bowel movements, and the inevitable damage to intestinal flora. Those side effects deserved a mention here.
This news release goes into a good level of detail about the clinical trial. It was a randomized, single-blind study involving 65 patient volunteers (51 treated with different doses of the novel formulation and 14 with two already available preps). The release states these early results warrant advancement to a larger, phase 3 trial.
It would have been informative to note the ages of the study participants. They ranged in age from 40 to 75.
Colon cancer is an important public health issue. But the release may overstates things when it says, “Approximately 40% of those who ought to have a colonoscopy avoid the procedure…” We’re uncomfortable painting with a broad brush regarding who “ought” to be screened for colon cancer. Screening is a personal choice based on an evaluation of benefits and harms.
The developer of this prep, ColonaryConcepts, LLC, is clearly identified in the news release, and a couple of other sources are also clearly linked to the company. However, one source, identified as the principal investigator for the study, is described in a conference abstract as a consultant for the company, but that was not made clear in the release.
The clinical trial compares the outcomes of this colonoscopy prep to that of two existing, FDA-approved preps. But we’re never told what those preps were. There are many approved preparations including combining Gatorade with polyethylene glycol, tablets and laxatives.
The release also could have mentioned that while colonoscopy is considered by some to be the gold standard, some groups, like the US Preventive Services Task Force, recognize other screening approaches including fecal occult blood screening and sigmoidoscopy. However, sometimes these procedures must be followed by a colonoscopy in the event of a positive screen.
The news release makes it clear that the results reported come from a Phase 2 clinical trial and that Phase 3 trials may begin in early 2017. Put another way, the prep is not yet available.
The news release uses the term “novel” to describe this new prep formulation. Although a variety of preps are now available, this study’s novelty appears to be its high level of patient satisfaction.
The release doesn’t include any sensational or unjustified language.
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 (2)
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Joan Kureczka
October 20, 2016 at 11:37 amWhile I’m happy to take the constructive comments in the spirit in which they are offered, the first one — about cost — is simply premature and not able to be responded to in the way the critics request. A product in Phase 2 has a long way to go, and the company developing it at this stage may or may not even be the one making decisions on pricing, as they may or may not be the firm to handle ultimate commercialization. Many considerations go into pricing decisions and it is simply to early to comment on this point.
Kevin Lomangino
October 20, 2016 at 2:38 pmJoan,
Thanks for your reply and for your open-minded approach to our critique. Indeed, we recognize that it may be too early to provide detailed cost estimates for an experimental product such as this. However, our rule of thumb on this issue is, “If it’s not too early to talk about how well something might work, then it’s not too early to start discussing what it may cost.” If we can speculate that the product “Could Help Increase Patient Acceptance of Colonoscopies for Colorectal Cancer Screening” (something this study didn’t look at), can’t we speculate in a ballpark way as to what people would have to pay for this? One way to address this would be to discuss the costs of existing alternatives. Couldn’t you discuss the cost of the existing colonoscopy prep products, to give consumers some sense of the range? Would the new product be expected to be in that same range or more/less expensive? Certainly someone within the company must have given thought to such issues? We grade very generously, and any reasonable attempt to address this criterion would be rewarded with a Satisfactory rating.
Again, I appreciate your comments and hope you’ll give some thought to this. We recognize that these are criteria that news release writers may not expect to be judged on but we hope you’ll consider them for next time.
Kind regards,
Kevin Lomangino
Managing Editor
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