Weight Loss Surgery and Kids - Part 4

Pediatric Metabolic and Bariatric Surgery: Evidence, Barriers, and Best Practices by Armstrong et al.

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This series is part of the work I did with WIND (Weight Inclusive Nutrition and Dietetics) to create a comprehensive response to the disastrous American Academy of Pediatrician (AAP) guidelines for higher-weight children. I was part of the team that analyzed the research that, the AAP claims, supports their recommendations, and I’ll be publishing my breakdowns here as well.

You can find the other studies here:
Part 1
Part 2
Part 3

Today I’m looking at Pediatric Metabolic and Bariatric Surgery: Evidence, Barriers, and Best Practices by Armstrong SC, Bolling CF, Michalsky MP, Reichard KW

Quick Guide:

·          Numerous conflicts of interest exist among the paper’s authors and the AAP funders

·         The data sources used do not provide adequate subjects, follow-up time, or capture of adverse events to support the paper’s broad-based recommendations.

·         Even with the limited subjects (and significant attrition during follow-up,) short-term data, and lack of consistent reporting of adverse events, a pattern of malnutrition and additional surgeries is apparent.

·         The reasoning for the surgery is based on correlation between higher weight and health issues with no exploration of potentially confounding variables or comparison of surgical interventions to health-supporting behaviors (in terms of both benefits and risks)

·         The recommendations predicate risk on size, rather than symptomology. Suggesting that adolescents who they categorize as “class 2 ob*se” must have “clinically significant disease” to qualify for surgery but those they categorize as “class 3 ob*se” qualify based on their BMI alone.

 Here’s the deeper dive:

Conflicts of Interest

Note that this is not a study but a “policy statement” by AAP and published by AAP in their own journal. There is significant overlap between these authors and the authors of the AAP Guidelines, meaning that any unchecked biases are likely to be present in both.

The fact that the correlational nature as well as causal ambiguity of the studies which are cited is ignored suggests that the authors are not exploring a question, but rather attempting to prove what they already believe/want to be true.

Despite the fact that the paper claims no conflicts of interest, the authors are predominantly people who have careers in the weight-centric paradigm and, in particular, weight management in children, some of whom will profit directly should these recommendations be broadly accepted. Several of the authors take payments from companies that also stand to profit from these recommendations. Some AAP funders also stand to gain financially from the recommendations contained herein.

Introduction

Note: The text in italics is quoted from the study itself, it may contain weight stigma and be triggering, you can skip it and just read my commentary.

Severe ob*sity among youth is an “epidemic within an epidemic” and portends a shortened life expectancy for today’s children compared with those of their parents’ generation.

There is no citation for any of this, and the authors who originally claimed that today’s children may have shorter life expectancies than their parents have admitted that those were “back of the envelope numbers.” While this is an introduction, fomenting fear to encourage a dangerous healthcare intervention through the use of unsupported, hyperbolic rhetoric is neither scientific nor ethical.

Emerging evidence has linked severe ob*sity to the development and progression of multiple comorbid states, including increased cardiometabolic risk resulting in end-organ damage in adulthood. Lifestyle modification treatment has achieved moderate short-term success among young children and those with less severe forms of ob*sity, but no studies to date demonstrate significant and durable weight loss among youth with severe ob*sity.

The ”emerging evidence” does not control for the confounding variable of weight cycling which, by their own omission here, is the most common outcome of the “lifestyle modification treatments” that are prescribed to these children. In adults, that weight cycling is linked with the same “comorbid states” that they are discussing here.

Metabolic and bariatric surgery has emerged as an important treatment for adults with severe ob*sity and, more recently, has been shown to be a safe and effective strategy for groups of youth with severe ob*sity.

This is stated as if it’s a fact but is, at best, an opinion.

Study Claims and Refutations

These children are at high risk for developing chronic and progressive diseases, including hypertension, dyslipidemia, obstructive sleep apnea, polycystic ovarian syndrome, type 2 diabetes mellitus, fatty liver disease, bone and joint dysfunction, depression, social isolation, and poor quality of life.3–7

In general there are a number of issues with this, including that it all rests on the assumption that higher-weight people’s lab values should be the same as those of lower-weight people. I did not find polycystic ovarian syndrome in any of the studies cited in support of this statement. It is also important to note that, while some of the studies they cite point this out, the authors of this paper are ignoring possible confounding variables including weight stigma and weight cycling, as well as the fact that, for example, PCOS, obstructive sleep apnea, blood glucose dysregulation et al. are known to cause weight gain. Looking at the studies they cite to support this statement:

3 - Li L, Pérez A, Wu LT, et al. Cardiometabolic risk factors among severely ob*se children and adolescents in the United States, 1999-2012. Child Ob*s. 2016;12(1):12–19

This is a study that shows a simple correlation (with no causation) between higher weight and blood pressure (BP), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), total cholesterol (TC), triglycerides, and fasting glucose (FG). The prevalence of high BP, high TC, low HDL, high triglycerides, high LDL, and high FG among “severely ob*se” adolescents was 9.9%, 16.5%, 40.0%, 30.0%, 13.0%, and 26.8%. The study fails to control for confounding variables including experience of weight stigma and weight cycling, it also fails to see if health-supporting behaviors make a difference. It should be noted that in every correlation the majority (and in some cases the vast majority) of those classified as “severely ob*se” did NOT have these conditions.

4 - Jasik CB, King EC, Rhodes E, et al. Characteristics of youth presenting for weight management: retrospective national data from the POWER study group. Child Ob*s. 2015;11(5):630–637

This includes one year (2009-2010) of data on 6737 adolescents which found a simple correlation (with no causation) between “severe ob*sity” and higher odds of laboratory abnormalities for hemoglobin A1c alanine aminotransferase, and elevated systolic blood pressure. There was no control for experience of weight stigma, weight cycling, or behavior as a mitigating factor, nor any exploration the reason that the majority of “severely ob*se” subjects did not have these “laboratory abnormalities.”

5 - Skinner AC, Perrin EM, Skelton JA. Cardiometabolic risks and ob*sity in the young. N Engl J Med. 2016;374(6):592–593

This included 412 adolescents and assessed the simple correlation between “severe ob*sity” and total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein cholesterol, triglycerides, blood pressure, glycated hemoglobin, and fasting glucose with no causal mechanism identified. They found that in HDL cholesterol, mean values were lower with higher weight. There was a higher risk of low HDL, high blood pressure, triglycerides and glycated hemoglobin levels. In all cases, the majority (and often the vast majority) of those classified as “severely ob*se” did not have elevated risk factors. Further, some of the risk factors could be due to unidentified conditions that can also cause higher weight, or factors like weight cycling and weight stigma.

6 - Modi AC, Loux TJ, Bell SK, et al. Weight-specific health-related quality of life in adolescents with extreme ob*sity. Ob*sity (Silver Spring). 2008;16(10):2266–2271

This study included 145 adolescents and uses the made up category of “extreme ob*sity” (which they are defining as BMI ≥ 40) and examines health-related quality of life scores (HRQOL). While they find differences for those they categorize as “extremely ob*se” they also found significant differences based on gender and race, and they acknowledge that they do not know to what extent any or all of the differences might be due to weight stigma. The study also utilizes the Impact of Weight on Quality of Life – Kids (IWQOL – Kids) assessment, which is a deeply biased assessment, encouraging blaming of body size rather than experience of stigma and/or lack of accommodation, and which its own authors explain is “especially valuable to ob*sity researchers, clinicians, psychologists, medical device and/or pharmaceutical companies seeking to validate the effectiveness of their treatments for ob*sity”

7 - Kelly AS, Barlow SE, Rao G, et al; American Heart Association Atherosclerosis, Hypertension, and Ob*sity in the Young Committee of the Council on Cardiovascular Disease in the Young, Council on Nutrition, Physical Activity and Metabolism, and Council on Clinical Cardiology. Severe ob*sity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the American Heart Association. Circulation. 2013;128(15):1689–1712

This is not a study but a “statement” that simply summarizes the correlational data.

 Roux-en-Y gastric bypass (RYGB) is often referred to as the gold standard for surgical management of severe ob*sity in adults 8,9  and adolescents 7  and is performed by using minimally invasive, laparoscopic surgical techniques.

8 - Zhang Y, Wang J, Sun X, et al. Laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass for morbid ob*sity and related comorbidities: a meta-analysis of 21 studies [published correction appears in Ob*s Surg. 2015;25(1):27]. Ob*s Surg. 2015;25(1):19–26

Meta-analysis found that in adults Roux-en-Y creates more weight loss, but except for Type 2 Diabetes had no statistically significant difference in “co-morbidity” resolution, and is less safe than sleeve gastrectomy, which does not support this paper’s authors’ statement that it is the “gold standard.”  Follow-up is divided in the abstract into “0.5-1.5 years” and “after that.”

9 - Courcoulas AP, Christian NJ, Belle SH, et al; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe ob*sity. JAMA. 2013;310(22):2416–2425

The authors have significant conflicts of interest, including research grants from Allergan, Pfizer, Covidien, EndoGastric Solutions, Covidien and sanofi-aventis, the Ob*sity Society for the Use of Nutrisystem after Bariatric Surgery, Shire Pharmaceutical,  Ethicon Endosurgery, “the manufacturer of the Lap-band, Allergan Health, a company that may have a commercial interest in the results of this research,” GlaxoSmithKline, Crospon, Viudico, and Medtronics and Enteromedics.

This study looks at adults with three years of follow-up after surgery and thus has no applicability to the AAP guidelines. They found that most of the weight was lost in year one and weight for almost all participants was trending upward at the end of the 3-year follow-up. It should be noted that the first 1-3 years after these surgeries are often referred to as the “honeymoon period” due to the fact that the long-term side effects of the surgery as well as malnutrition and malabsorption have not yet begun.

7 - Kelly AS, Barlow SE, Rao G, et al; American Heart Association Atherosclerosis, Hypertension, and Ob*sity in the Young Committee of the Council on Cardiovascular Disease in the Young, Council on Nutrition, Physical Activity and Metabolism, and Council on Clinical Cardiology. Severe ob*sity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the American Heart Association. Circulation. 2013;128(15):1689–1712

This is not a study but a “statement” that simply summarizes the correlational data.

RYGB results in significant weight loss as a result of its effects on appetite, satiety, and regulation of energy balance.9

9 - Courcoulas AP, Christian NJ, Belle SH, et al; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe ob*sity. JAMA. 2013;310(22):2416–2425

The authors have significant conflicts of interest, including research grants from Allergan, Pfizer, Covidien, EndoGastric Solutions, Covidien and sanofi-aventis, the Ob*sity Society for the Use of Nutrisystem after Bariatric Surgery, Shire Pharmaceutical,  Ethicon Endosurgery, “the manufacturer of the Lap-band, Allergan Health, a company that may have a commercial interest in the results of this research,” GlaxoSmithKline, Crospon, Viudico, and Medtronics and Enteromedics.

This study looks at adults (and so doesn’t apply to the population covered by the AAP recommendations,) and only provides 3 years of follow-up. They found that most of the weight was lost in year one and weight for almost all participants was trending upward at the end of the 3-year follow up. It’s should be noted that the first 1-3 years after these surgeries are often referred to as the “honeymoon period” due to the fact that the long-term side effects of the surgery as well as malnutrition and malabsorption have not yet begun.

Vertical sleeve gastrectomy (VSG) leads to weight loss through similar effects on appetite, satiety, and regulation of energy balance and may reduce appetite through delayed gastric emptying and altered neurohormonal feedback mechanisms.10

10 - Benaiges D, Más-Lorenzo A, Goday A, et al. Laparoscopic sleeve gastrectomy: more than a restrictive bariatric surgery procedure? World J Gastroenterol. 2015;21(41):11804–11814

The efficacy studies cited by this paper only offer 1-3 years of follow-up on adults which is insufficient to determine weight regain or long-term side effects and not extrapolatable to an adolescent population.

Data Sources

Note: The data sources utilized are comprised of a total of only 1520 total subjects (with some overlap) and subjects are predominantly cis-female and overwhelmingly white which, again limits extrapolation. Even with relatively short-term follow-up they show significant side effects.

16 Inge TH, Courcoulas AP, Jenkins TM, et al; Teen-LABS Consortium. Weight loss and health status 3 years after bariatric surgery in adolescents. N Engl J Med. 2016;374(2):113–123

This study offers only 3 years of follow-up on just 242 patients which is inadequate to determine long-term effects. Concerningly, within just three years hypoferritinemia (low iron) was found in 57% of the participants, and 13% had undergone one or more additional intraabdominal procedures. Weight was trending back up at the end of follow-up.

18 - Inge TH, Jenkins TM, Xanthakos SA, et al. Long-term outcomes of bariatric surgery in adolescents with severe ob*sity (FABS-5+): a prospective follow-up analysis. Lancet Diabetes Endocrinol. 2017;5(3):165–173

This study, partially funded by Ethicon, a company that profits from bariatric surgery, followed 58 adolescents with a mean age of 17 for somewhere between 5 and 12 years (mean of 8). At follow up 46% had mild anemia, 45% had hyperparathyroidism, 16% had low amounts of vitamin B12. They did not attempt to capture other adverse events or additional required surgeries.

19 - Olbers T, Gronowitz E, Werling M, et al. Two-year outcome of laparoscopic Roux-en-Y gastric bypass in adolescents with severe ob*sity: results from a Swedish Nationwide Study (AMOS). Int J Ob*s. 2012;36(11):1388–1395

Offers just two years of follow-up on only 81 adolescents and found adverse effects in 33% of the population in just those two years.

20 - Olbers T, Beamish AJ, Gronowitz E, et al. Laparoscopic Roux-en-Y gastric bypass in adolescents with severe ob*sity (AMOS): a prospective, 5-year, Swedish nationwide study. Lancet Diabetes Endocrinol. 2017;5(3):174–183

A five-year follow-up on the same population as the study above (19). Found that 11% of those who had the surgery lost less than 10% of their body weight, 25% had to have additional abdominal surgery for complications from the original surgery or rapid weight loss, and a full 72% showed some type of nutritional deficiency.

21 - Messiah SE, Lopez-Mitnik G, Winegar D, et al. Changes in weight and co-morbidities among adolescents undergoing bariatric surgery: 1-year results from the Bariatric Outcomes Longitudinal Database. Surg Ob*s Relat Dis. 2013;9(4):503–513

This study offers one year of follow-up on 259 adolescents (original n was 890, with 454 undergoing gastric bypass and the rest getting gastric banding. Only 259 of the original 890 were still participating at 12 months.) Forty-five readmissions occurred among gastric bypass patients with 29 reoperations required.

They conclude that “Bariatric surgery can safely and substantially reduce weight and related co-morbidities in morbidly ob*se adolescents for ≥1 year.” But they didn’t actually study beyond 1 year, they failed to fully capture adverse events and they are ignoring the 71% who had dropped out by year one.

22 - Al-Sabah SK, Almazeedi SM, Dashti SA, et al. The efficacy of laparoscopic sleeve gastrectomy in treating adolescent ob*sity. Ob*s Surg. 2015;25(1):50–54

Looks at 135 patients in Kuwait with a median age of 19 with follow-up ranging from 9 months to 2.6 years. The study is not publicly available and so details are not available.

23 - Alqahtani AR, Antonisamy B, Alamri H, Elahmedi M, Zimmerman VA. Laparoscopic sleeve gastrectomy in 108 ob*se children and adolescents aged 5 to 21 years. Ann Surg. 2012;256(2):266–273

108 patients in Saudi Arabia with 12-24 months follow-up. They report “no serious postoperative complications and no adverse sequelae” which is inconsistent with all other studies and calls into question the definitions they were using for serious postoperative complications and adverse sequelae and[or whether the extreme attrition (3 mos (n = 88), 6mos (n = 76), 12mos (n = 41), and 24mos (n = 8) meant that these were not captured because those with negative experiences left the study.

24 - 24Black JA, White B, Viner RM, Simmons RK. Bariatric surgery for ob*se children and adolescents: a systematic review and meta-analysis. Ob*s Rev. 2013;14(8):634–644

This was a meta-analysis of 637 patients which found that “bariatric surgery leads to significant short-term weight loss…however, the risks of complications are not well defined in the literature.”

The short follow-up, high levels of adverse effects (in particular nutritional deficiencies,) and re-surgery rates do not, to me, come close to supporting this study’s claims of safety and efficacy or, subsequently, the  AAP’s recommendation to perform these surgeries starting at age 13.

Complications

The study admits that long-term implications of nutrient deficiency are unknown and that there is limited data on postoperative anxiety and depression. I would point out that there is also limited data on re-surgery rates and other adverse outcomes due to low study numbers and attrition during follow-up. This is significant because the surgery creates a life-long disease state in the digestive system, but the follow-up is at most 12 years and far more typically only 12 months.

Eligibility

Current longitudinal studies evaluating safety and efficacy endpoints do not apply specific age limits for the timing of surgery; thus, there is no evidence to support the application of age-based eligibility limits.11,20

This is a deeply misleading statement. The fact that the (small sample) of current longitudinal studies don’t apply age limits does not suggest that there should be no application of age-based eligibility, especially when there is an extreme paucity of inclusion/data of pediatric and young adolescent populations in the data.

Barriers – Access

Medical necessity is defined as “health care interventions that are evidence-based, evidence-informed, or based on consensus advisory opinion…to promote optimal growth and development in a child and to…diagnose, treat, ameliorate or palliate the effects of physical conditions

They are making the argument that these surgeries should be offered to more adolescents based on their “medical necessity” but the paucity of data and the lack of attention paid to weight-neutral interventions means that the claim of “medical necessity” of these surgeries is not supported by the data they offer.

Barriers – Lifestyle Counseling

In this section they contend that surgeries should be performed earlier because lifestyle treatments typically do not lead to weight loss (though it should be noted that these treatments are still recommended in the AAP Guidelines, which have many of the same authors.) Again, they are focused only on weight and do not engage with actual health at all.

Practice Recommendations

Recognize that severe ob*sity (BMI ≥35 or ≥120% of the 95th percentile for age and sex, whichever is lower) places the adolescent at higher risk for liver disease, type 2 diabetes mellitus, dyslipidemias, sleep apnea, orthopedic complications, and mental health conditions even when compared with milder degrees of ob*sity.

This uses correlation to assign risk and fails to examine possible confounding variables (including, but not limited to, weight cycling, weight stigma, and healthcare inequalities)

Seek high-quality multidisciplinary centers that are experienced in assessing risks and benefits of various treatments for youth with severe ob*sity, including bariatric surgery, and provide referrals to where such programs are available.

Several of the paper authors are involved in these centers, but claim no conflict of interest. Regardless of where the patient is referred, there is insufficient data to support the long-term safety or efficacy of bariatric surgery for children and adolescents.

Understand the efficacy, risks, benefits, and long-term health implications of the common metabolic and bariatric surgery procedures so that pediatricians can effectively help in family medical decision-making concerning surgical options to manage severe ob*sity.

This information, in particular long-term health implications, are not truly available due to an extreme paucity of data which is even more sparse for younger populations, people of color, cis males, and trans and non-binary people. There can be no true informed consent with this little long-term data and these limited study populations.

Identify pediatric patients with severe ob*sity who meet criteria for surgery (Table 1), and provide timely referrals to comprehensive, multidisciplinary, pediatric-focused metabolic and bariatric surgery programs.

There is insufficient data to support these recommendations and their criteria predicate risk on size rather than symptomology.

Coordinate pre- and postoperative care with the patient, family, and multidisciplinary, anesthesia, and surgical teams.

This fails to take into account that the adolescent getting the surgery may not be in control of whether or not those responsible for their care will take that responsibility seriously and, as minors, have little recourse if they fail to do so.

Monitor patients postoperatively for micronutrient deficiencies and consider providing iron, folate, and vitamin B12 supplementation as needed.

This fails to take into account both the fact that adolescent patients are unlikely to be in control of their sources of food and supplementation and that the natural drive for independence can lead adolescent populations to refuse to “comply” with medical recommendations including medication/supplementation.

Systemic Level Recommendations

The AAP recommends that pediatricians do the following.

Advocate for increased access for pediatric patients of all racial, ethnic, and socioeconomic backgrounds to multidisciplinary programs that provide high-quality pediatric metabolic and bariatric surgery.

The data do not support the long-term safety or efficacy of these surgeries. Several of the authors of the paper run such programs and stand to benefit financially from these recommendations but claim no conflicts of interest. Also several direct funders of the AAP will also benefit from this recommendation.

The AAP recommends that government, health, and academic medical centers do the following.

Use best practice guidelines outlined in this policy statement to support safe and effective multidisciplinary, pediatric-focused metabolic and bariatric surgery programs. This guidance is considered best practice because it is based on consensus expert opinion after reviewing numerous practices in various settings.

This guidance should not be considered best practice due to the paucity of data and author and publisher conflicts of interest.

Consider best practice guidelines, including avoidance of unsubstantiated lower age limits, in the context of potential health care benefits and individualized patient-centered care.

Their claims of “unsubstantiated lower age limits” are not based on the safety and efficacy of the surgery for younger populations but, rather, a complete lack of data. It is not appropriate to create a permanent disease state in the healthy digestive system of a young child just because they weren’t included in studies that could find issues with long-term safety or efficacy. Again, authors and AAP funders stand to gain financially from this recommendation.

Increase the number of and access to multidisciplinary, pediatric-focused metabolic and bariatric surgery centers, ensuring equal access to adolescents who meet criteria regardless of income, race, or ethnicity.

The data do not support this, and those who fund the AAP (and from whom some of the authors have taken payments) stand to gain financially from this recommendation.

The AAP recommends that public and private insurers do the following.

Provide payment for multidisciplinary preoperative care to ensure appropriate selection of surgical candidates and for multidisciplinary postoperative care and required medications and supplements to improve surgical outcomes.

Provide payment for bariatric surgery from evaluation through follow-up and ongoing care for pediatric patients who meet standard criteria as set forth here.

Reduce barriers to pediatric metabolic and bariatric surgery (including inadequate payment, limited access, unsubstantiated exclusion criteria, and bureaucratic delays in approval requiring unnecessary and often numerous appeals) for patients who meet careful selection criteria.

The data do not support any of these recommendations and those who fund the AAP (and from whom some of the authors have taken payments) stand to gain financially from this recommendation.

Monitor patients postoperatively for risk-taking behavior and mental health problems.

The minors who will be undergoing these procedures have no guarantee that such monitoring will occur and limited to no recourse or options if it does not.

Again, this paper does not in any read like an exploration of a question but, rather, like a desperate attempt to prove what the authors want to be true. With the lives and quality of life of youth on the line, we need to do way, way better than this.

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More research and resources:
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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.