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Food Safety Lecture–It is Still A Jungle Out There

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Yesterday, I posted a blog that tried to summarize some of William Balistreri’s talk on Global Health.  He gave a 2nd Excellent Lecture on Food Safety at the Georgia AAP Nutrition Symposium.  One audience member suggested that this lecture was well-paired with the previous lecture as the awareness of food-borne illnesses might deter gluttony.

This lecture was packed with information regarding food safety; he highlighted the extensive and frequent food-borne illnesses.

Key points:

  • The problem of food-borne illness was put under a spotlight by Upton Sinclair in The Jungle (1906) which led to reforms in meat packing industry.  However, more work is needed
  • FSMA -Food Safety Modernization Act was signed into law in 2011; it’s aim is to create a proactive rather than reactive approach, Historic opportunity to increase food safety
  • Food-borne illnesses: 1 in 10 persons worldwide will be sick every year & leads to 1/2 million deaths worldwide each year.  125,000 deaths in children
  • Food-borne illnesses: 48 million cases in U.S. each year (CDC estimates) and 3000 deaths (MMWR 64:2, 2015)
  • Besides significant mortality rates for food-borne illnesses, they also contribute to post-infectious irritable bowel syndrome (~13% of all cases) and these illnesses can be indefinite
  • Social media, including “IwasPoisoned.com” and Yelp, will likely help identify outbreaks more quickly.  Newer molecular technologies during food processing has the potential to improve food safety.

Resources:

  • For those who want to keep up food-borne illnesses, Dr. Balistreri recommended food safety news, which provides daily emails. Link to subscribe: Food Safety News
  • Two books that were recommended: The Poison Squad by Deborah Blum and Outbreak by Timothy Lytton
  • The CDC has plenty of advice and a useful pamphlet regarding the key 4 steps with food preparation: Clean, Separate, Cook, Chill. https://www.cdc.gov/foodsafety/keep-food-safe.html
  • Another resource: FoodSafety.gov

Link to full talk slides PDF: FOOD SAFETY (10-10-19)  I have placed about 20 slides below which summarize much of the information that he conveyed.

 

 

Anti-TNF Therapy: Might Save Your Health But Not Your Wallet

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A recent study (LE Targownik, EI Benchimol, J Witt et al. Inflamm Bowel Dis 2019; 25: 1718-28) shows that direct health care costs are increased with anti-TNF therapy.

In this retrospective study using the Manitoba IBD Database, the authors examined the direct costs associated with anti-TNF therapy initiation in 928 patients (676 CD, 252 UC).  Only 84 subjects were <18 years.

Key findings:

  • The median costs for health care in the year of anti-TNF initiation increased compared to prior year.  In year prior to initiation, median costs were $4698 for CD and $6364 for UC; in the first year of anti-TNF treatment, costs rose to $39,749 and $49,327 respectively.
  • Costs remained elevated through 5 years of anti-TNF therapy for continuous users with total median of $210,956 and $245,260 respectively
  • There were reductions in non-drug costs. Inpatient and outpatient costs decreased in the year after anti-TNF initiation by 12% and 7% respectively, when excluding the costs of anti-TNFs.  These observed savings are considerably less than the medication expenditures.

Discussion:

  • Costs for medications are likely to improve with the introduction of biosimilars.  Currently these are being used mainly in persons with a new diagnosis due to reticence to switch from originator product in established patients.
  • The authors note that costs were overall higher with infliximab (IFX) than adalimumab (ADA) though “it is possible that patients with higher-severity disease are channeled toward IFX over ADA.”
  • Indirect costs like ability to go to work and achieve educational potential could offset some of the direct costs.  In a prior study in the U.S., ADA treatment was estimated to reduce indirect costs of “nearly $11,000 per person treated.”

Limitations:

  • Some costs were not measured in the study including emergency room visits, over the counter medications and alternative health care use.
  • This was not a randomized study; thus, it is impossible to know what costs of persons with similar disease who were untreated would have been.

My take: This study shows that saving money is not the main reason to use anti-TNF therapies; rather, their effects on improved health and fewer complications.

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Haystack Rock, Cannon Beach OR

IBD Shorts -October 2019

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Briefly noted:

D Piovani et al. Gastroenterol 2019; 157: 647-59.  This study examined environmental risk factors for inflammatory bowel disease after extensive literature review and assessment of meta-analysis.

9 factors that were associated with increased risk of IBD:

  • smoking (CD)
  • urban living (CD & IBD)
  • appendectomy (CD)
  • tonsillectomy (CD)
  • antibiotic exposure (IBD)
  • oral contraceptive use (IBD)
  • consumption of soft drinks (UC)
  • vitamin D deficiency (IBD)
  • Heliobacter species (non-Helicobacter pylori-like) (IBD)

7 factors that associated with reduced risk of IBD:

  • physical activity (CD)
  • breatfeeding (IBD)
  • bed sharing (CD)
  • tea consumption (UC)
  • high folate levels (IBD)
  • high vitamin D levels (CD)
  • H pylori infection (CD, UC, and IBD)

EL Barnes et al. Inflamm Bowel Dis 2019; 1474-80. In this review which identified 12 studies and 4843 with an IPAA ( ileal pouch-anal anastomosis) for ulcerative colitis, 10.3% were ultimately diagnosed with Crohn’s disease. Link to full text and video explanation: The Incidence and Definition of Crohn’s Disease of the Pouch: A Systematic Review and Meta-analysis

EV Loftus et al. Inflamm Bowel Dis 2019; 1522-31. In this study with 2057 adalimumab-naive patients, “the proportion of patients in HBI remission increased from 29% (573 of 1969; baseline) to 68% (900 of 1331; year 1) and 75% (625 of 831; year 6). Patients stratified by baseline immunomodulator use had similar HBI remission rates.”  Full text: Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry

The following study was summarized in previous blog: Oral Antibiotics For Refractory Inflammatory Bowel Disease  Full text link: Efficacy of Combination Antibiotic Therapy for Refractory Pediatric Inflammatory Bowel Disease

Washington Park, Portland, OR

Fewer Surgeries with Crohn’s Disease

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Briefly noted: NE Burr et al. Clin Gastroenterol Hepatol 2019; 17: 2042-49.

In a retrospective cohort (1994-2013) using a primary care database from England, the authors identified decreasing risk of surgeries with Crohn’s diseae (CD).

  • From 1994-2003, the risk of first surgery dropped from 44% to 21%.
  • The risk of a second resection dropped as well, from 40% in 1994 to 17% in 2003 (with 10-year followup)

The reasons for this reduction are not certain but could include better clinical care or reduction in other risk factors (like smoking).

Atlanta Botanical Garden

Quantifying the Risk of Autoimmunity for Celiac Disease

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A recent study (MR Khan et al. JPGN 2019; 69: 438-42) examined the rates of autoimmune disorders (AD) among patients with celiac disease (CD) (n=249) compared to a control group (n=498) over an 18 year period (1997-2015). The authors utilized the  a database of medical records via the Rochester Epidemiology Project (Mayo Clinic/Olmstead County).

Key findings:

  • Five years after the index date, 5.0% of CD patients and 1.3% of controls had a de novo AD diagnosis
  • In the pediatric age group, there was an increased risk of AD: 5/83 (7.3%) of CD patients and 0/179 (0%) developed a AD diagnosis at the 5-year mark
  • The authors note that they observed a lower rate of Hashimoto thyroiditis after the diagnosis of CD, likely indicating a protective role of a gluten-free diet
  • Thyroid disorders, type 1 DM, psoriasis/psoriatic arthritis and rheumatoid arthritis were the most common AD identified in patients with CD

Limitations:

  • Retrospective study
  • Adherence with GFD was not assessed

My take: Screening for AD periodically is worthwhile in patients with CD, particularly thyroid disorders and type 1 diabetes which accounted for ~80% of the autoimmune conditions identified.

Briefly noted: R Ahawat et al. JPGN 2019; 69: 449-54. In this study with 38 newly-diagnosed CD, the authors found a high prevalence of low vitamin D (25OHD) levels (65.8%) -defined as <30 ng/mL; however, the control population had a higher rate of 79.3%.  While the authors advocate checking vitamin D levels due to the risk of bone disease, it is noted that bone mineral density and vitamin deficiencies frequently improve with a gluten-free diet (Related post: Celiac studies)

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Barcelona

Vedolizumab versus Adalimumab for Ulcerative Colitis (part 2)

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A previous blog post (Vedolizumab More Effective Than Adalimumb for Ulcerative Colitis) highlighted a preliminary report on the “VARSITY” study. The full report has now been published (BE Sands et al NEJM 2019; 381: 1215-26) and a little nuance is needed.

This double-blind, double-dummy randomized trial included 769 patients who underwent randomization to receive at least one dose of one of the study medications.

Key findings:

  • At week 52, clinical remission was higher in the vedolizumab group: 31.3% compared to 22.5% for adalimumab
  • Endoscopic improvement was better for vedolizumab: 39.7% compared to 27.7%
  • Corticosteroid-free remission was better for adalimumab: 21.8% compared to 12.6% for vedolizumab

Limitations:

  • dose escalation was not allowed during the study –this limitation likely favors vedolizumab compared to adalimumab
  • previous exposure to an anti-TNF agent was allowed in up to 25% of patients

My take:  In two of three key measures, vedolizumab outperformed adalimumab.  This study provides a rationale for vedolizumab to be considered a first-line agent.  That being said, in my clinical experience, infliximab is a much more frequently used anti-TNF agent in moderate-to-severe ulcerative colitis.  So a head-to-head study with infliximab would be of interest.

The image below shows histologic remission differences at week 52

 

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What to Tell Patients About Ranitidine From AGA

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Here’s the link: Talking to your patients about ranitidine  Thanks to John Pohl for sharing this information.

Oct. 3, 2019

Talking to your patients about ranitidine

The recent FDA safety alert might be causing concern among your patients about their heartburn treatment.

The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, that were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.

The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. 

With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available. 

TALKING TO YOUR PATIENTS 

The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that: 

  • Ranitidine is an H2 blocker (antihistamine) — available OTC and in prescription strength — used to prevent and relieve heartburn associated with acid ingestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
  • Not all ranitidine medicines marketed in the U.S. are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
  • It might be prudent to hold off taking Zantac until a final FDA conclusion.
  • Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
  • Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.

Related blog post: Preliminary Recommendations from NASPGHAN on Ranitidine Warnings

Ustekinumab for Ulcerative Colitis (UNIFI Trial)

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A landmark study (BE Sands et al. NEJM 2019; 381: 1201-14) shows that ustekinumab (Stelara) can be an effective therapy for moderate-to-severe ulcerative colitis (UC); it is already an approved, established therapy for Crohn’s disease. This randomized placebo-controlled study included an 8-week induction trial (n=961) followed by a 44-week maintenance trial (n=523) for patients with response.

Clinical remission was defined as a total socre of ≤2 on the Mayo scale (range 0-12) and no subscore >11 on any of the four Mayo scale components.

Key findings:

  • During induction, there was a similar clinical remission rate between those who received 130 mg fixed intravenous dose compared to those who received 6 mg/kg: 15.6% and 15.5% compared to 5.3% for placebo group.
  • During maintenance, among patients receiving 90 mg every 8 weeks the clinical remission rate at 44 weeks was 43.8%, in those with 90 mg every 12 weeks the rate was 38.4%; placebo group was 24.0%.
  • The response to ustekinumab occurred in those with or without previous treatment failure with biologic agents, though response was lower in both induction and maintenance in those with prior treatment failure.  In both phases, at least 59% of participants had failed either or both anti-TNF agents or vedolizumab.
  • In this study, there were similar serious adverse events with ustekinumab compared to placebo.  In the treatment groups, there were two deaths (one from ARDS, one from esophageal varices) and 7 cases of cancer (3 nonmelanoma skin cancer, two colon cancer, one prostate, one renal).  There was one death from testicular cancer in the placebo group. Also four patients in the ustekinumab group had opportunistic infections including CMV in two, legionella in one and HSV in one.

In terms of dosing, the authors note that there was greater improvement in calprotectin values during induction in the group who received 6 mg/kg compared to those who received 130 mg.  At week 44, using more objective and stringent end points (eg. endoscopic improvement), greater clinical benefit was observed with the every 8 week regimen.

Visual abstract from NEJM Twitter Feed:

The following image depicts patients response during the maintenance phase –the lightest color is placebo, followed by every 8 weeks, and then the darkest color is every 12 weeks.  The x-axis measures (left to right) are clinical remission, maintenance of clinical response at week 44, endoscopic improvement, corticosteroid-free remission, and remission at 44 weeks in those with remission after induction.

My take: Ustekinumab is more effective for placebo in patients with ulcerative colitis.  More experience is needed to understand its long-term safety.

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“Bystander Effect” –Not the Norm

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A recent study has cast some “shade” on the concept of the “bystander effect.”

From Washington Post: Forget What You May Have Been Told. New Study Shows Strangers Help 90 Percent of the Time

An excerpt:

Bystanders will intervene 9 times out of 10 to assist the victim in a public fight, an international team of researchers found in a study called “Would I be helped?,” published in American Psychologist this summer. After reviewing surveillance footage of more than 200 violent altercations around the world, the researchers concluded that having more bystanders around makes it more likely that someone will intervene…

On average, at least three people chose to intervene — and every additional bystander present increased the odds that the victim would receive assistance by roughly 10 percent.

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