FDA Warning: Five Die While Using Obesity Devices (Intragastric Balloons)
An excerpt:
At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
The FDA says it doesn’t know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.
Related blog post: In the News: Weight Loss Intragastric Balloons
A recent commmentary (D Patel, KT Park. JPGN 2017; 134-6) explains the topic of interchangeability and its relationship to biosimlars. While biosimilars are expected to reduce the cost of biologic therapy, there are concerns regarding immunogenicity and whether switching to these products could reduce therapeutic sustainability.
The authors explain that some products are truly interchangeable and produce the same clinical result. An interchangeable medicine (eg. typical generic) does not increase safety risk and switching from originator drug can be done by pharmacists or government payers without intervention of the prescribing health provider.
CT-P13 (Inflectra) has been approved as a biosimilar but has not been deemed an interchangeable product. This is important. Biosimilars “could have clinical consequences and repeated switches may increase immunogenicity.” Also, biosimilar products are much more complicated products than typical generic drugs.
Other key points:
My take: We still have a lot to learn. Until more studies are available, switching stable patients could increase risk of losing response.
Related blog posts:
Dry Falls, Highlands NC
The AGA has made several recommendations regarding biosimilars –#2 and #6 are particularly of interest to pediatric gastroenterologists. More on this topic will follow tomorrow.
Link: AGA Makes Six Recommendations to FDA on Interchangeable Biosimilars
Related blog posts:
This post provides the full abstract from today’s earlier post.
A retrospective study (Inflamm Bowel Dis 2017; 23: 1447-53) describes assessment of mucosal healing in pediatric patients with inflammatory bowel disease.
Here is abstract:
Background: Mucosal healing (MH) is associated with improved clinical outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC). MH as a target for treatment has been suggested, although there is little pediatric data. The goal of this study was to evaluate MH in clinical practice in pediatric patients with inflammatory bowel disease in clinical remission.
Methods: A retrospective review of electronic health record data was performed on all patients with CD or UC who underwent at least 2 colonoscopies from 2010 through 2016. Only patients in clinical remission undergoing a scope for MH were included in our study. The incidence of MH and histologic healing (HH) was analyzed, along with cumulative rates of MH in each group. MH was defined by both physician assessment of MH and an endoscopic score of zero for CD and UC.
Results: A total of 76 patients with CD and 28 patients with UC underwent at least one MH scope while in clinical remission. Of the 76 patients with CD, 51 patients (67%) demonstrated MH by physician assessment, 34 patients (45%) demonstrated MH by a simple endoscopic score for CD of zero, and 35 patients (46%) demonstrated HH. Of the 28 patients with UC, 20 patients (71%) demonstrated MH by physician assessment, 10 patients (36%) demonstrated MH by a Mayo score of zero, and 10 patients (36%) demonstrated HH. Nineteen patients underwent a second MH scope and 11 (58%) demonstrated MH by physician assessment, 7 patients (37%) demonstrated MH by simple endoscopic score for CD or Mayo scores of zero, and 5 patients (26%) demonstrated HH. Of those patients with active disease, 21 of 25 patients with CD underwent escalation of therapy, whereas 8 of 8 patients with UC underwent escalation of therapy. Cumulative rates of MH when defined by physician assessment were 79% (60 of 76 patients) in CD and 79% (22 of 28 patients) in UC.
Conclusions: MH is feasible in pediatric CD and UC, and rates of cumulative MH in pediatric patients are similar to previously published adult data. In children with inflammatory bowel disease in clinical remission, approximately one-third demonstrate active disease at endoscopy.
In 2014, an influential study by Sandborn et al (Clin Gastroenterol Hepatol 2014; 12: 978-85) described the importance of mucosal healing in a strategy termed “treating to target.” The main findings (reviewed in a previous post Treating to Target) were the following:
Now, my colleagues at Emory have published a single-center experience on mucosal healing (MH) (SL Santha, PR Shankar, A Pan, B Schoen, S Kugasthasan, CG Sauer. Inflamm Bowel Dis 2017; 23: 1447-53). While this study has the typical limitations of a retrospective study, it makes several useful points. It takes a little extra effort to interpret their findings as they describe their results based only on the 104 patients with clinical remission rather than based on the total of 182 patients who had at least two colonoscopies. 78 were excluded due to ‘acute GI symptoms.’
Of the 104 patients considered to be in clinical remission, 76 had Crohn’s disease and 28 patients had ulcerative colitis.
Key findings:
The discrepancy in MH rates based on physician assessment, endoscopic scores, and histologic healing is explained. Generally, MH based on physician assessment would include normal and those with very mild mucosal disease. “For CD, this included small and rare aphthous ulcers, and for UC, this included mild Mayo 1 erythema in only one segment of bowel.”
Questions about the approach to ‘treating to target:’
As in adult patients, this study does show the need for objective markers in pediatric inflammatory bowel disease; 30% of patients who were considered to be in clinical remission had active disease with further investigation. This finding has implications for ImproveCareNow which uses physician global assessment in tracking remission rates for pediatric IBD.
In their discussion, the authors state that “changes in medical therapy can increase the MH rate to nearly 80%, which could be even higher with additional changes in those who did not demonstrate MH on a second endoscopy.” This sentence needs to be carefully interpreted. The authors were able to show MH based on physician assessment in 82 of 104 patients (79%) who were in clinical remission. This rate would be MUCH lower if the entire cohort of 182 were included, possibly no greater than 50%.
The authors conclude with “endoscopy should be considered in pediatric patients with IBD in clinical remission to identify those without MH who may require medication escalation despite the absence of clinical symptoms.”
My take: I agree with the authors that objective markers of clinical remission need to be obtained to assess the effectiveness of therapy. However, I am not convinced that endoscopy is needed in every patient who is doing well on therapy; other biomarkers and imaging may be more beneficial.
Related blog posts:
Sign at Pisgah Fish Camp Restaurant: “On this site in 1897 nothing happened.”
In many cases of Apparent Life-Threatening Events (ALTEs) (also called Brief Resolved Unexplained Events, BRUEs) in infants, the exact reasons are unclear. Sometimes these events are blamed on reflux despite studies indicating this is unlikely in the vast majority (see links at bottom of post).
A recent study (DR Duncan, J Amirault, PD Mitchell, K Larson, RL Rosen. JPGN 2017; 65: 168-73) finds that oropharyngeal dysphagia is correlated with ALTEs.
In this retrospective study which took place between 2012-15, the authors reviewed all patients admitted with ALTE. They excluded infants with underlying diseases that included known neurologic impairment, congenital heart disease, and other congenital anomalies.
Demographics:
Key findings:
Conclusion (from authors): “Oropharyngeal dysphagia with aspiration is the most common diagnosis identified in infants presenting with ALTEs. The algorithm for ALTE should be revised to include an assessment of VFSS as clinical feeding evaluations are inadequate to assess for aspiration.”
Related blog post: What to do with ALTEs
Also, an except and link from NASPGHAN Consensus guidelines on GERD (2009)
Dry Falls, Highlands, NC
“I refuse to accept the view that mankind is so tragically bound to the starless midnight of racism and war that the bright daybreak of peace and brotherhood can never become a reality.” Martin Luther King, Jr
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More information on hepatitis B virus (HBV) reactivation with direct-acting antiviral (DAA) hepatitis C virus (HCV) therapy has been published:
In a previous post on this topic (Word of Caution with New Hepatitis C Medications:), it was noted that physicians need to be aware of HBV reactivation with DAAs. It appears that HCV can suppress HBV replication and that successful HCV therapy allows for HBV reactivation.
Belperio et al reviewed data from an observational study on more than 62,000 HCV-infected veterans, including 377 who had HBsAg-positivity and 7295 who had anti-HBc-positivity.
Key findings:
Chen et al performed a systematic review (of 28 studies included) and meta-analysis had identified overt HBV reactivation in 12.2% of those receiving DAAs. This was a lower rate of HBV reactivation than with interferon (14.5%); however, reactivation during DAA therapy occurred earlier (typically 4-12 weeks into treatment) and was more clinically significant. There was significant variation in the virologic and ALT criteria used to define HBV reactivation. The authors conclude that it is “important to have HBV serology (HBsAg, anti-HBc) in all HCV patients prior to therapy.
Perillo recommends that in addition to screening, “it is my belief that anti-HBV prophylaxis be given to all HBsAg-positive patients, ” regardless of HBV DNA level.
My take: These articles help quantitate the risk of HBV reactivation during HCV therapy.
Ben Sawyer Bridge, Sullivans Island
Related blog posts:
Swing bridge, Ben Sawyer Bridge, Sullivans Island
NBC News: One in Three Americans Took Prescription Opioid Painkillers in 2015
An excerpt: How many Americans are using prescription opioid painkillers? About one in three.
That’s the stunning number in a new survey released Monday from the National Institute on Drug Abuse, which calculated that a whopping 91.8 million Americans used drugs like OxyContin or Vicodin in 2015.
And nearly five percent of the adults surveyed told researchers they took these drugs without their doctor’s permission, the study reported. They didn’t get their meds from some seedy drug dealer, either.
“The most commonly reported sources were friends and relatives for free,” the study reported. “Or a physician.”
A recent retrospective study (LF Gonzalez Ballesteros et al Bone 2017; 97: 287-92) of 17 centers in North America and Ireland (2014-2016) identified a frequent association between an elemental formula and idiopathic hypophosphatemia in infants and children.
Key findings:
Since the composition of the formula had adequate phosphate, the authors speculate that the “bioavailability of formula phosphorus may be impaired in certain clinical settings.” Interestingly, this report singles out Neocate® products, “although the possibility of hypophosphatemia may occur with other amino-acid based formulas cannot be excluded.” Neocate® infant has similar amounts of phosphorus as Elecare®: 82.2 mg of phosphorus per 100 kcal compared with 84.2 mg.
My take: In patients receiving exclusive amino-acid based formulas (especially Neocate®), it is probably worthwhile to periodically monitor phosphate, calcium, alkaline phosphatase and possibly other micronutrients.
College of Charleston
A recent summary by 538 website details how surgery can be a powerful placebo: Surgery Is One Hell of a Placebo
Here’s an excerpt:
“expectations matter, and we know they matter because of a bizarre research technique called sham surgery. In these fake operations, patients are led to believe that they are having a real surgical procedure…
A 2014 review of 53 trials that compared elective surgical procedures to placebos found that sham surgeries provided some benefit in 74 percent of the trials and worked as well as the real deal in about half.1 Consider the middle-aged guy going in for surgery to treat his knee pain. Arthroscopic knee surgery has been a common orthopedic procedure in the United States, with about 692,000 of them performed in 2010,2 but the procedure has proven no better than a sham when done to address degenerative wear and tear, particularly on the meniscus…
Even without a robust placebo effect, an ineffective surgery may seemhelpful. Chronic pain often peaks and wanes, which means that if a patient sought treatment when the pain was at its worst, the improvement of symptoms after surgery could be the result of a condition’s natural course, rather than the treatment. That softening of symptoms from an extreme measure of pain is an example of the statistical concept of regression to the mean.
My take: Both with medicine and surgery, sometimes improvement occurs even when the treatment itself is not effective.
Dupont Forest, NC
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