While one of my recent posts (Weight of the Nation) hinted at the need for structural changes to help in the fight against obesity, this link to an article from USA Today (From brain to mouth: The psychology of obesity) discusses some of the psychological aspects.
Author Archives: gutsandgrowth
200 years of Health Law
“We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own sources of anguish, and with some measure of triumph.” Elie Wiesel
For those who want to specialize in health law quickly, a good reference is NEJM 2012; 367: 445-50 which completes the task in five pages (& includes the quote from Elie Wiesel).
- Apparently physicians and lawyers did not get along much better in 1812 according to this article. Thomas Percival’s original title for his influential 1803 Medical Ethics text was Medical Jurisprudence. About half of this text is devoted to “professional duties…which require a knowledge of law.”
- Early medical malpractice case in 1767: Slater v Baker and Stapleton. Slater sued after treatment for his broken leg had a poor result; the jury awarded £500 (equivalent to £60,000 in 2012).
- Coffee quack case in 1807. A “physician” claimed to cure all fevers with several concoctions, including drugs he called “coffee.” When a patient died, it was felt that he had been poisoned by the “coffee.” The so-called physician was brought to trial but acquitted. The judges instructions: “it is to be exceedingly lamented, that people are so easily persuaded to put confidence in these itinerant quacks.” No adequate legal remedy if prescribed “with honest intentions and expectations of relieving his patients.” This case led to the first physician-licensing law in 1818 (Massachusetts).
Landmark events:
- 1905 Jacobson v Massachusetts –no right to refuse smallpox vaccine
- 1946-47 Nuremberg trials –Nuremberg code set forth in judgement
- 1973 Roe v Wade –right to terminate pregnancy
- 1990 Cruzan v Director (Missouri Dept of Health) –right to refuse life-sustaining treatment
- 1997 Washington v Glucksberg and Vacco v Quill –no right to physician-assisted suicide
- 2012 Nat’l federation of independent business v Sebelius –upheld patient affordable care act
Lessons about HBV in NYC
Hepatitis B infection remains a leading cause of cirrhosis and liver cancer worldwide. In the U.S., the prevalence is estimated at 0.3-0.5% of the population. An updated look at the epidemiology comes from NYC (MMWR 2012; 61: 6-9). Investigators randomly selected 180 HBV cases (2008-2010) and investigated them.
Findings/take-home points:
- Two-thirds were Asian.
- In 70%, the clinician did not know any of patient risk factors
- In 62%, the clinician did not know hepatitis A vaccination status (despite recommendations)
- Main reasons for testing: 27% birth country prevalence, 12% elevated liver tests, 2% hepatitis signs/symptoms
- Only 75% received counseling regarding transmission
As a result of this investigation, the department of health initiated multiple changes:
- Clinicians were contacted regarding HAV vaccinations
- Booklet for patients developed: How to Tell Others You Have Chronic Hepatits B
- Patient education booklet developed: Hepatitis B: the Facts
These booklets (in five languages) can be ordered in bulk and free of charge within NYC and also online at
Hepatitis B The Facts, Eng.qxp:For Internet, 5.5×8.5 – NYC.gov
Hep B Guide to Telling 7 11_Hep B Chronic – NYC.gov
Other useful links:
DO YOU NEED A HEPATITIS B TEST? – NYC.gov
Hepatitis C The Facts, Eng.qxp:For Internet, 5.5×8.5 – NYC.gov
Previous related blog entries:
Unrelated link -but worth a look (thanks to Larry Saripkin for showing me this useful training video):
“dont go ninjin nobody that dont need ninjin” Kung Fu Hillbilly – Training Video – YouTube
Weight of the Nation
A perspective article, NEJM 2012; 367: 389-391, addresses the topic of whether Americans are ready to solve the problem of obesity. Short answer: No!
The article discusses the Institute of Medicine (IOM) report “Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation” along with the accompanying HBO documentary (HBO: The Weight of the Nation).
“The centerpiece of THE WEIGHT OF THE NATION campaign is the four-part documentary series, each featuring case studies, interviews with our nation’s leading experts, and individuals and their families struggling with obesity. The first film, CONSEQUENCES, examines the scope of the obesity epidemic and explores the serious health consequences of being overweight or obese. The second, CHOICES, offers viewers the skinny on fat, revealing what science has shown about how to lose weight, maintain weight loss and prevent weight gain. The third, CHILDREN IN CRISIS, documents the damage obesity is doing to our nation’s children. Through individual stories, this film describes how the strong forces at work in our society are causing children to consume too many calories and expend too little energy; tackling subjects from school lunches to the decline of physical education, the demise of school recess and the marketing of unhealthy food to children. The fourth film, CHALLENGES, examines the major driving forces causing the obesity epidemic, including agriculture, economics, evolutionary biology, food marketing, racial and socioeconomic disparities, physical inactivity, American food culture, and the strong influence of the food and beverage industry.”
While the IOM report identifies a need for structural changes in our environment, public opinion consistently focuses on personal responsibility.
- 64% identify overeating, lack of exercise, and watching too much TV as the biggest causes
- 18% identify external factors as the biggest causes, including exposure to junk food, lack of safe places to play, limited availability of healthy foods
Obstacles for addressing this problem also include the following:
- Obesity-prevention efforts may further stigmatize individuals. The article specifically cites criticism aimed at ‘ads that aired in Georgia;’ these were pulled after concerns of increasing obesity stigma.
- “Issue-attention cycle” problem. “This pattern occurs when initial public alarm over the discovery of a problem and optimism about its quick resolution are replaced by the realization that solving the problem will require some public sacrifice and will displace powerful societal interests.”
Related blog posts:
Treating diabetes with surgery
Today’s AJC -celiac disease and gluten sensitivity
Today’s AJC has a story regarding celiac disease as well as gluten sensitivity. Gluten a problem or a fad?
Related posts from this blog:
Do medicines work for GERD infants?
“Absence of evidence is not evidence of absence.” Carl Sagan
If medicines work for infantile GERD, it is difficult to prove (Winter H, et al. JPGN 2012; 55: 14-20). The cited study is the latest having difficulty proving that proton pump inhibitors are effective in infants. In this randomized, double-blind, placebo-controlled multinational study from 33 centers, 98 infants (1-11 months) were enrolled. My colleague, Dr. Benjamin Gold, was one of the researchers. Initially, a 2-week open-label treatment was given which was followed by a 4-week randomized phase. Study participants had to have a clinical diagnosis of GERD with at least one GERD symptom –at least twice per week in a 4-week period:
- vomiting/regurgitation
- irritability
- supraesophageal manifestations (cough, wheeze, stridor)
- respiratory symptoms triggered by feedings
- feeding difficulties
The treatment administered was weight-based dosing of esomeprazole:
- 3-5 kg: 2.5mg
- 5-7.5kg 5mg
- 7.5-12kg 10mg
Daily symptoms were captured with an interactive voice response system. Among the initial 98 patients enrolled, 80 reached the randomization phase. During the initial 2-week period, 81 (82.7%) had symptom improvement based on physician global assessment. During the double-blind phase, 48.8% of placebo-treated patients and 38.5% of esomeprazole-treated patients discontinued therapy due to symptom worsening. While the time for discontinuing esomeprazole was longer in a posthoc analysis, the primary outcome, discontinuation rate, was not significantly different.
So what is the reason that this was a negative study? While the reasons are unclear, all of the following are possible:
- Patient selection/lack of accurate diagnosis. Mixed-population was recruited for the study –though this type of population is similar to clinical practice.
- Dose of esomeprazole.
- Inadequately powered study. If the effectiveness of PPIs is small, a much larger population is needed.
- Maybe these agents don’t work in infants. Infants secrete less acid than children and adults; thus, acid blockers may not work as well. (The Medical Pendulum and Gastroesophageal Reflux)
Why not give PPIs even if they don’t work? The previous link discusses many of the potential adverse problems that are possible with medical treatment of GERD. However, even if a medicine does not harm does not mean you should do something because it ‘might’ do some good. An example of this is the apocryphal tale of the famous pianist who died one day in the middle of a recital. (I saw this in a journal article but cannot remember the reference.) The manager came out to announce his death. A man in the audience shouts, ‘Give him an enema.’ Initially, the manager tries to ignore him. After the man yells this three times, the manager responds, ‘the poor man is dead…what good will an enema do?’ The voice replies, ‘What harm will it do?
Additional references:
- -JPGN 2010; 50: 609-18. Pantoprazole helped improve symptoms but there were no significant differences compared to placebo in withdrawal rates due to lack of efficacy. n=128.
- -NASPGHAN 2009, Abstract#21. Meds/Rx of NICU pts did not shorten hospital stay or promote wt gain, n=1149. Abstract#26. prevacid more effective than ranitidine in infants.
- -J Pediatr 2009; 155: 601 (letter). Should not be used to treat symptoms unless proven to be reflux.
- -JPGN 2009; 49: 498. GERD guidelines. “In infants and toddlers, there is no symptom or symptom complex that is diagnostic of GERD or predicts a response to therapy.” Identical response to placebo (vs prevacid) in largest double-blind randomized study (54% at 4 weeks) (J Pediatr 2009; 154: 514-20.) Reflux is “not a common cause of unexplained crying. irritability..in otherwise healthy infants.” “There is no evidence to support the empiric use of acid suppression for the treatment of irritable infants.”
“Fatal attraction”
Today’s 33Charts topic Children and Magnets: a Fatal Attraction gives an update on rare earth magnet ingestions (neodymium) along with some other useful links.
Addendum: Also a link from NY Times on 8/17/12: http://www.nytimes.com/2012/08/17/business/for-buckyballs-toys-child-safety-is-a-growing-issue.html?_r=1&nl=todaysheadlines
Previous posts on this topic:
How helpful are probiotics?
Nobody really knows. Claims about their efficacy are often based on poorly designed studies. Efficacy of each strain for specific conditions and with specific dosing is often lacking. One recent negative study demonstrates that probiotics are often not beneficial (J Pediatr 2012; 161: 40-3).
In this randomized, double-blind placebo controlled study of 106 Polish children (1-48 months of age), Lactobacillus reuteri had no effect in preventing nosocomial diarrhea in patients admitted for non-diarrheal illnesses. While the authors contemplate that this could be due to the strain of probiotic chosen or the dose, it is clear that evidence that probiotics prevent infectious diarrhea “is still scant.”
This conclusion is backed by a large meta-analysis (JAMA 2012; 307: 1959-69). While the study concludes that the use of probiotics is associated with a lower risk of antibiotic-associate diarrhea (RR 0.58), it predicted that the number to treat for one person to benefit would be 13. The study was based on a systematic review of 82 randomized clinical studies. Yet, overall the quality of the research was considered low; the studies were often had shortcomings:
- 59 studies “lacked adequate information to assess the overall risk of bias”
- 64 did not indicate if treatment randomization was blinded
- 31 did not report an intent-to-treat analysis
- 41 did not include a calculation of the study’s statistical power to detect differences
- 17 trials were industry-sponsored and 52 did not clarify their funding/potential conflicts of interest
- 59 did not report on adverse events specifically related to probiotic use; few trials addressed the risk of fungemia or sepsis
- Trials rarely specified antibiotic agents; thus, it is difficult to know if a particular probiotic would be better with certain types of antibiotic therapy or duration.
Additional references/links:
- Potential and pitfalls of probiotics with necrotizing enterocolitis
- -JPGN 2010; 51:24. VSL#3 helpful for IBS, n=509 (4-18yr olds). 1 per day for <11yr, 2/day in 12-18yr olds
- -Pediatrics 2008; 121:e850. Culturelle, during pregnancy and early infancy, not effective in preventing atopic dermatitis. Did increase wheezing.
- -J Pediatr 2008; 152: 801. Probiotic helped reduce colic sx in 30 preterm infants, Lactobacillus reuteri
- -Pediatrics 2007; 119; e124. Probiotics reduced colic in breastfed babies more than simethicone. n=83, Lactobacillus reuteri, 10-8th power per day. Decreased crying 18 minutes per day at 1 week compared to simethicone & by 94 minutes/day at 4 weeks (95% response vs 7% of simethicone)
- -Neurogastroenterol Motili 2007 (Quigley EM, et al), 19: 166-72. Review of probiotics and IBS.
- -NASPGHAN 2007, author: Brian Dunlap, H. Yu, Y Elitsur. abstract -most commercial yogurts have LOW concentrations of probiotics.
- -JPGN 2006; 43: 550. Review of probiotics for specific conditions.
- -J Pediatr 2006; 149: 367. Probiotics reduce risk of antibiotic assoc diarrhea. If 7 pts (on abx) are treated with probiotics, one fewer will develop AAD.
- -JPGN 2006; 42: 454. Evidenced-based review of probiotics.
- -Pediatrics 2005; 115: 1-4 & 171 editorial. Probiotics decreased NEC in this study.
- -Gastroenterol 2004; 126: 1620-33. Review of probiotics, prebiotics and antibiotics in IBD.
Comparing diets in EoE
There remains a limited number of therapeutic options with EoE. Dietary therapy can be effective as well as burdensome. A closer look at dietary treatment effectiveness was recently published (J Allergy Clin Immunol 2012; 129: 1570-8 –thanks to Seth Marcus for alerting me to this article).
Due to eligibility requirements, only 98 patients of an initial 513 met criteria. The findings from this study may be difficult to generalize because of the following:
- Highly selected patient population
- Retrospective study. Dietary therapy was NOT chosen randomly.
- Study originates from a specialized center (Cincinnati) which attracts atypical cases of EoE
That being said, the study asks some important questions. What is the remission rate for skin test-directed elimination diet in comparison to six food group elimination diet (SFED) and to an elemental diet? The SFED actually composed two groups (in my opinion, this is a significant flaw in the study design & has a limiting effect on the conclusions). The ‘classical’ SFED (42% or 11/26) eliminated the six most common food groups (milk, soy, wheat, egg, nuts, fish/shellfish) whereas a ‘modified’ SFED (58% or 15/26) combined the classical SFED with foods eliciting positive skin-testing.
Some of the authors terminology:
- Complete remission: 1 or fewer eosinophils/hpf
- Partial remission: 2-5 eos/hpf
- Partial resolution: 6-14 eos/hpf
- Remission: <15 eos/hpf
- Non-remission: >15 eos/hpf
Skin prick tests (SPFs) were performed to as many as 62 foods and 11 environmental allergens and graded 0-4. 0 equated to negative control & 4 equated to histamine control -all interpreted at 15 minutes after placement.
Atopy patch tests (APTs) were interpreted at 48 hours with scoring between 0-4. A score of 2 indicated “erythematous with generalized induration.” Any score of 2 or higher was considered positive.
Food reintroduction process: “Food reintroductions were initiated only when the peak eosinophil count was less than 15 eosinophils/hpf. If symptoms occurred after reintroduction of a food, patients were instructed to discontinue that food, wait approximately 10 to 14 days, and then reintroduce another food…. A food reintroduction was considered successful if no symptoms were reported and the postpeak eosinophil count was less than 15 eosinophils/hpf.”
Why were so many patients excluded? The main causes were 181 patients did not meet strict EoE criteria, 122 patients received glucocorticoids, and 52 patients had another eosinophilia-associated condition; less common reasons included patient age >21, being part of a separate drug trial, obvious noncompliance, different diet regimen, and not having 2 consecutive EGDs separated by dietary intervention.
How many endoscopies are needed for dietary therapy? In this study, the average patient had 8.5 EGDs at Cincinnati. The greatest number of EGDs took place among patients assigned to an elemental diet (average >11); these patients also had a longer followup period compared to the other two groups: 2.9 years compared with 1.1 for SFED and 2.1 for directed diet.
- All three diets resulted in improvement in eosinophil count.
- Overall Remission rates: 96% elemental, 81% SFED, 65% directed diet
- Complete Remission rates: 59% elemental, 39% SFED, 30% directed diet
One interesting set of data is in Table 4. This gives the pass rate for various foods with single and multiple food reintroductions. Milk for example had a pass rate of 35% among the 17 patients who had this as a single food reintroduction. The values ranged from a low pass rate of 29% for strawberries to a high pass rate of 78% for cocoa and 75% for pork. Soy, eggs, and wheat all hovered near 60% pass rate.
Conclusions by authors:
1. “SFED is no less successful than directed diet and consistent with unreliability of skin testing …Our data…undermine the value of skin test-directed dietary management. ” This is due to the fact that the disease mechanism is not an IgE-mediated disease (skin testing primarily detects IgE-mediated allergens).
2. Elemental diet is superior at inducing histologic remission. However, “multiple studies indicate that adherence is inversely related to the number of foods eliminated.”
Previous related posts:
Guidelines for Eosinophilic Esophagitis
Looking better or feeling better in EoE?
Look of improvement on an EoE diet
Eosinophilic Esophagitis -Six Food Group Diet
Liver biopsy risk in children
A recent retrospective study from Oslo looks at risk factors and safety of liver biopsy (JPGN 55: 82-87).
Among 190 patients who underwent 275 ultrasound-guided liver biopsies (interventional radiology), there were four major complications –two were due to post-biopsy bleeding, one was due to variceal bleeding within 12 hours, and one was due to the development of pain/acidosis, and tachycardia. 28 patients had minor bleeding. There were no mortalities, though one patient dropped hemoglobin in half (11.6 to 5.3).
In their patient population, the following had increased risk for major complications:
- Focal space-occupying lesion/tumor (n=25) OR 2.84 for all bleeding risk; patients with these lesions typically had more biopsy passes (average 4.9)
- Acute liver failure (n=12) OR 26.1 for major complication risk
- Low-molecular weight heparin therapy (n=18) OR 2.43 for all bleeding risk
Not identified as risk factors for complications in this cohort:
- Low platelet count (<70 [n=14])or coagulopathy (INR>1.7 [n=18]), –all received blood products before biopsy
- Aspirin treatment (often used in transplant population to prevent hepatic artery thrombosis) (n=55) OR 0.96
- Liver transplant patients (n=97) -odds ratio was lower than entire cohort (OR 0.52)
Additional references:
- -JPGN 2011; 53: 202. Good safety results with IR liver biopsy, n=249. 2/249 had drop in Hgb of 2g -no transfusions needed, no mortalities.
- -Clin Gastro & Hep 2010; 8: 877. 0.5% complication rate, n=2740. No deaths. Bleeding was most common risk –increased with advanced liver disease.
- -Hepatology 2009; 49: 1017. AASLD Position Paper
- -Gastroenterol 1978; 74: 101 & 103. Early article discussing safety of LBx and that most pts could be d/c’d w/in 6 hours.
- -JPGN 2005; 41: 639. Safety of liver biopsy in infants less than 3 months (w/o U/S). complication rate was 18% including sedation-related, 1 bile leak, and 3 needed PRBCs.
- -JPGN 2003; 36: 364. Ultrasound useful.
- -Can J Gastroenterol 2000; 14: 543-548. Mortality rate 3/10,000
- -Clin Perspectives Gastroenterol 2002; 5: 117. Rec ultrasound, plts >75K, PT c/in 3 secs of normal; observation for 3-6hrs in adults.
- -NEJM 2001; 344: 495. Liver bx review.
- -Hepatol 27: 1220-26, 1998. U/S marking reduces complications
- -Fox VL, Cohen MB, Whitington PF, Colletti RB. Outpatient liver biopsy in children (n=450). J Pediatr Gastroenterol Nutr 1996;23:213-6. High mortality rate reported, primarily in bone marrow transplant patients
- -JPGN 2000; 31: 536-39. Safety of liver biopsy in children, n=249.
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