This news release issued by the U.S. Food and Drug Administration announces the agency’s approval of the drug plecanatide (marketed as Trulance) to treat adults with chronic idiopathic constipation (CIC), a form of constipation for which there is no consistent medical explanation.
The release notes that there are other treatments for the disorder and that this approval expands the options available. It also nicely clarifies that the drug has not been proven safe for those under age 18 and that it can cause mild to serious diarrhea. But it left out other side effects observed in the studies and is vague about the benefits. It would have been nice to include some numbers to put the potential value of the drug in perspective. It does explain that volunteers in two clinical trials “were more likely to experience improvement” in the frequency of bowel movements than those getting placebo, and “had improvements” in consistency and straining. But some quantitative or qualitative information would have been helpful.
In both clinical trials, the overall positive response rates were about 20 percent compared to 10 to 13 percent for placebo which suggests only a modest benefit — and the release could have pointed that out.
As the releasepoints out, constipation afflicts an estimated 42 million Americans, according to the National Institutes of Health, and the costs of treating, managing and coping with chronic forms and other “bathroom diseases” is staggering, both in dollars, doctor visits, and human suffering. Most of the historic means of treating or preventing CIC require eternal vigilance, and have serious limitations. The irritable bowel syndrome and constipation “industry” is lucrative, composed of products and advice that carry side effects of their own, and with which many people cannot comply over long periods of time. As a result, new drugs designed to target specific biochemical pathways linked to CIC can become instant (and expensive) best-sellers for legions of desperate patients, and news releases and stories need to be especially cautious about the limitations of these drugs and how they compare to traditional and less expensive alternatives.
Since the FDA evaluates drugs without consideration of cost we’re rating this Not Applicable. But we look forward to the day when FDA news releases include some mention of cost in its message. The value of a new drug is a function not just of how well it works, but its cost-effectiveness.
Pricing information for Trulance is likely to come soon in the wake of the FDA’s approval. For reference, other drugs aimed at the inflammatory bowel/gastrointestinal disorder market have carried high price tags. One such drug costs about $380 for a month’s supply of 30 capsules.
As noted in the summary above, the release did not provide readers with a realistic picture of the actual rate of improvement over placebo in the two clinical trials cited by the FDA in its approval process.
We rate this Satisfactory because the release includes the restrictions on pediatric use and the risk of severe diarrhea. The release would have been even better if it had mentioned how often the volunteers experienced side effects and the full scope of side effects.
The release describes the protocol of the studies used as a basis for its approval (“safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily.”)
We wish the release had included where the studies were published so that journalists and other interested readers can easily find more information. Most health intervention news releases do include these references.
No mongering here; CIC is widespread. The release provides context on the condition by citing its prevalence.
Although the release notes that Synergy Pharmaceuticals Inc. makes the new drug, it does not say where the clinical trial results were published or what groups supported or carried out the research.
A mention that there are numerous other prescription medications, over-the-counter drugs and lifestyle treatments available for this condition would have been beneficial here.
The FDA release announces approval and most readers will understand that this is essentially the last big step in market availability. The release would have been stronger had it noted that the drug may not be available widely for a short time.
The release could have noted in a bit more detail how this drug works compared to other drugs used to treat CIC, and especially how it differs from over-the-counter and “home” remedies.
The release doesn’t contain any unjustifiable language.
This news release issued by the U.S. Food and Drug Administration announces the agency’s approval of the drug plecanatide (marketed as Trulance) to treat adults with chronic idiopathic constipation (CIC), a form of constipation for which there is no consistent medical explanation.
The release notes that there are other treatments for the disorder and that this approval expands the options available. It also nicely clarifies that the drug has not been proven safe for those under age 18 and that it can cause mild to serious diarrhea. But it left out other side effects observed in the studies and is vague about the benefits. It would have been nice to include some numbers to put the potential value of the drug in perspective. It does explain that volunteers in two clinical trials “were more likely to experience improvement” in the frequency of bowel movements than those getting placebo, and “had improvements” in consistency and straining. But some quantitative or qualitative information would have been helpful.
In both clinical trials, the overall positive response rates were about 20 percent compared to 10 to 13 percent for placebo which suggests only a modest benefit — and the release could have pointed that out.
As the release points out, constipation afflicts an estimated 42 million Americans, according to the National Institutes of Health, and the costs of treating, managing and coping with chronic forms and other “bathroom diseases” is staggering, both in dollars, doctor visits, and human suffering. Most of the historic means of treating or preventing CIC require eternal vigilance, and have serious limitations. The irritable bowel syndrome and constipation “industry” is lucrative, composed of products and advice that carry side effects of their own, and with which many people cannot comply over long periods of time. As a result, new drugs designed to target specific biochemical pathways linked to CIC can become instant (and expensive) best-sellers for legions of desperate patients, and news releases and stories need to be especially cautious about the limitations of these drugs and how they compare to traditional and less expensive alternatives.
Since the FDA evaluates drugs without consideration of cost we’re rating this Not Applicable. But we look forward to the day when FDA news releases include some mention of cost in its message. The value of a new drug is a function not just of how well it works, but its cost-effectiveness.
Pricing information for Trulance is likely to come soon in the wake of the FDA’s approval. For reference, other drugs aimed at the inflammatory bowel/gastrointestinal disorder market have carried high price tags. One such drug costs about $380 for a month’s supply of 30 capsules.
As noted in the summary above, the release did not provide readers with a realistic picture of the actual rate of improvement over placebo in the two clinical trials cited by the FDA in its approval process.
We rate this Satisfactory because the release includes the restrictions on pediatric use and the risk of severe diarrhea. The release would have been even better if it had mentioned how often the volunteers experienced side effects and the full scope of side effects.
The release describes the protocol of the studies used as a basis for its approval (“safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily.”)
We wish the release had included where the studies were published so that journalists and other interested readers can easily find more information. Most health intervention news releases do include these references.
No mongering here; CIC is widespread. The release provides context on the condition by citing its prevalence.
Although the release notes that Synergy Pharmaceuticals Inc. makes the new drug, it does not say where the clinical trial results were published or what groups supported or carried out the research.
A mention that there are numerous other prescription medications, over-the-counter drugs and lifestyle treatments available for this condition would have been beneficial here.
The FDA release announces approval and most readers will understand that this is essentially the last big step in market availability. The release would have been stronger had it noted that the drug may not be available widely for a short time.
The release could have noted in a bit more detail how this drug works compared to other drugs used to treat CIC, and especially how it differs from over-the-counter and “home” remedies.
The release doesn’t contain any unjustifiable language.
Systematic, Criteria-Driven
I try never to use "now more than ever" but "now more than ever" we need @garyschwitzer . https://twitter.com/garyschwitzer/status/1263549341748338690
"The cutbacks in staffing in news organizations are deep and terribly disruptive to quality journalism. But we still do have terrific journalism about COVID-19 being delivered every day by leading news organizations."
To wit: 👇
Fun read. Welcome to cutbacks & crazy times. https://twitter.com/garyschwitzer/status/1263549341748338690
Comments (2)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Jess Brown
May 27, 2017 at 10:55 amHey guess what? There is no need for them to talk about other alternatives. Obviously if you’re on this med nothing else has worked. And obviously you know nothing of how it feels to have this condition.
Kevin Lomangino
May 27, 2017 at 11:10 amThe review is not targeted only at people who are “on this med” and I very much disagree that there is no need to talk about alternatives. Because the information in this news release could reach lots of people with or without constipation (or their loved ones), it’s important to discuss alternatives and give people a complete picture of the options. Whether or not we understand how it feels to have this condition is not really relevant.
Kevin Lomangino
Managing Editor
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