1. Gastric Bypass: Continuing Issues Walter J. Pories, MD, FACS Professor of Surgery, Biochemistry, Sport and Exercise Science Brody School of Medicine East Carolina University

2. Disclosures Grant support – NIH – Johnson & Johnson, Ethicon EndoSurgery – Glaxo Smith Kline – HRSA – Brody Brothers Foundation – Golden LEAF Foundation Surgical Review Corporation: Board of Directors

3. Gastric Bypass: A Summary RYGB is a safe and effective operation Durable remission of diabetes, hypertension, NASH, GERD and other co-morbidities of severe obesity Lowers morbidity and mortality rates High rates of patient satisfaction Long-term follow-up is required – Nutritional problems – Internal hernias – Psychologic challenges

4. Issue #1: What is a Gastric Bypass? A lack of standardization makes comparisons difficult Open? Laparoscopic? NOTES? Gastric pouch: size? Vertical? horizontal? Gastro-jejunostomy: hand sewn? Stapler: circular? or linear? Antecolic? retrocolic? Length alimentary limb? Length bilio-pancreatic limb? Jejuno-jejunostomy: size? Stapled? Hand sewn ?

5. Issue #1: What is a Gastric Bypass? A lack of standardization makes comparisons difficult 16 variables: 131,072 variations ---difficult to defend Suggestion: ASMBS Committee consider developing 3 – 4 standard models Voluntary participation by surgeons Assessment by BOLD

6. Issue #2: Should we settle for an 80% remission rate of T2DM after RYGB? Observation: Remission rates of diabetes following gastric bypass are lower in older patients and those who have had diabetes longer

7. Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets? All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256 XS WT Loss 46.2% 57.9% ? 60% 63.6% Stop T2DM 56.7% 80.3% ? 60% 95.1%

8. Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets? All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256 XS WT Loss 46.2% 57.9% ? 60% 63.6% Stop T2DM 56.7% 80.3% ? 60% 95.1% Is the 20% failure rate really due to exhaustion of the islets?

9. Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets? All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256 XS WT Loss 46.2% 57.9% ? 60% 63.6% Stop T2DM 56.7% 80.3% ? 60% 95.1%

10. Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets? All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256 XS WT Loss 46.2% 57.9% ? 60% 63.6% Stop T2DM 56.7% 80.3% ? 60% 95.1% No, actually, insulin levels are high even in advanced disease. The islets are damaged but able to respond adequately.

11. Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets? All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256 XS WT Loss 46.2% 57.9% ? 60% 63.6% Stop T2DM 56.7% 80.3% ? 60% 95.1% The rate of remission is “dose related” to the exclusion of food from the gut. To Rx advanced T2DM, more radical Operations are needed.

12. Issue # 2: Is it time to consider adjusting bariatric surgery to our patients? Bands: BMI > 30 Moderate weight loss, few co-morbidities RYGB: BMI >35 with major co-morbidities Duodenal Switch: Patients with diabetes who are older, on insulin or had diabetes over eight years Perhaps BOLD might help us define the guidelines

13. Issue # 3: How long will we accept that our patients do not have access to the only effective therapy? (*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person) No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

14. Time to Change Strategies 39.8 million Americans are obese (BMI > 30 15 million are severely obese (BMI > 35) Bariatric operations in 2009: 180,000 180,000/15,000,000 = 0.12% What if we had a pill that could reverse diabetes, severe obesity, crippling arthritis, etc. Would 99.8% of the population accept denial?

15. Time to Change Strategies Educate the primary care colleagues? Educate the endocrinologists? Educate the carriers? Educate Medicare and Medicaid? Get real: They all know; they are threatened Get real: none have much to gain The common complaint: – No randomized, prospective clinical trials

16. Randomized, prospective trials are not required for proof of concept :

17. Where are the randomized, clinical trials of insulin vs. no insulin?

18. Oral

19. Should an IRB approve randomization between an effective proven therapy (RYGB) vs. medical therapy? Ethics of a randomized clinical trial:

20. Time to Change Strategies The demand for bariatric surgery will only increase when patients and their families become aware that they do not have to accept the ADA’s motto: “Living with Diabetes” It’s time to let the patients know they are being denied life-saving care, that they can live without diabetes. NOW!!