News and Trends—July 2015

| July 1, 2015

Cincinnati, Ohio—Ethicon announced a $3.2 million investment in clinical research to better understand how earlier surgical intervention may improve conditions such as obesity and Type 2 Diabetes. Through its Time to Act on Obesity commitment, Ethicon is sponsoring more than 20 clinical trials and investigator-initiated studies (IIS) in five countries to understand which patients will see the greatest impact, and from which specific procedures. Ultimately, this data may help support expanded access to bariatric and metabolic surgery for patients who qualify around the world.

“We know that metabolic disease has reached pandemic proportions, as nearly 30 percent of the world’s population is overweight or obese[i]. We are calling our commitment, our rallying cry, It’s Time to Act on Obesity. And, if ever there’s a time—a tipping point, when we can make a difference—it’s now,” said Michael del Prado, Ethicon Company Group Chairman. “Ethicon will continue working to reverse the trajectory of obesity by connecting the brightest clinical researchers and surgeons with our unparalleled science, economic insights and global reach to find long-term solutions.”

As part of its signature program, Ethicon will fund new areas of not only clinical, but also economic evidence to shape the future of how obesity and metabolic disease is treated, and to work with governments to appropriately expand access to surgical intervention for more patients. The company carefully analyzed where patients with obesity and metabolic disease demonstrate the greatest need across the world, and how efforts and programming can increase access to critical surgical interventions that has the potential to reverse or resolve their obesity or metabolic conditions.

The clinical trials involve over two thousand patients across India, China, Brazil, France and the US. Each region’s unique barriers to adoption of surgery were carefully considered when determining where Ethicon could make the biggest impact. Example initiatives, aligned to specific barriers by country, include the following:

•    In India, Ethicon’s investment will help address the gap in clinical evidence specific to the challenges of Indian patients, who often have lower BMI, but uncontrolled diabetes. In addition, the company will compile economic evidence, informed by population-specific data, to increase funding in the private sector. Ethicon’s involvement in addressing these barriers has already helped deliver India’s first ever (but limited) bariatric surgery reimbursement, which reinforces the critical need for surgery as a medical treatment, not a cosmetic procedure.
•    In China, one critical focus of the investment is to provide clinical data to illustrate the safety, efficacy and supporting evidence of bariatric surgery, specifically for patients of Chinese descent. Ethicon is also investing in economic evidence and country partnerships to help advance certified Bariatric and Metabolic Surgery Centers of Excellence in China, to help address the lack of specialized surgeons and legitimize obesity as a disease.
•    In France, a barrier to adoption of bariatric surgery is the lack of consistent guidelines on how to treat the disease, as is limited funding from the government for obesity treatment. Ethicon is funding disease-state peer-reviewed publications and sponsoring medical society sessions to align on consensus guidelines for surgeons and directive treatment guidelines for referring physicians on how to treat obesity. An additional investment in real-world customizable economic models will help demonstrate the cost-effectiveness of treating obesity and metabolic disease with surgery, to policy makers and payors.
•    Patients in Brazil face a unique challenge because there is a high demand for bariatric and metabolic surgery, but due to funding restrictions in the public sector, patients are typically placed on a waiting list for up to seven years. Ethicon is working to assess the cost and impact of delaying the treatment of obesity, while co-morbidities continue to progress, versus the cost of earlier surgical intervention. This data will support potential increased governmental funds for bariatric surgery in the public health care system.
•    In the US, the care path for treating obesity and metabolic disease is highly complex. Ethicon’s investment will fund additional and/or extended clinical trials in partnership with highly regarded clinicians to understand the durability of remission of co-morbidities like Type 2 Diabetes linked to bariatric and metabolic surgery. The investment will also expand education for patients and referring physicians of clinical data to reinforce obesity as a medical disease that can require medical intervention. Furthermore, Ethicon’s economic focus has been instrumental in driving expanded coverage for bariatric and metabolic surgery across multiple employers and cities within the US, extending coverage to more than 19 million last year alone.

“The ultimate questions we’re always seeking to answer are: who is the right patient, what is the right procedure, and is this the right time?” said Elliott Fegelman, MD, Ethicon’s Medical Director for Obesity and Metabolic Disease. “In the US, the term ‘diabesity’ is gaining popularity because of the inextricable link between Type 2 diabetes and obesity. That’s the reverse of what we know to be true in Asia. For example in China, they’re recording upwards of 114 million patients[ii] who have uncontrolled Type 2 Diabetes, but develop it much earlier on the BMI curve, meaning they’re not as obese. We don’t see that same level of interdependence—that perceived cause-and-effect in Asia, between obesity and diabetes. These regional nuances, as we look across the US, Asia, Europe and Latin America, all require different and distinctive solutions, and that’s what our investment will help deliver.”

The Time to Act on Obesity commitment is a continuation of Ethicon’s investment and leadership in device innovation and professional and patient education offerings. This includes the ground-breaking Metabolic Applied Research Science (MARS) data[iii] which shed new light on how bariatric and metabolic surgery works to improve conditions such as obesity and Type 2 Diabetes. The announcement enables the company to bring the most promising clinical and economic data to market, helping to reverse the devastating impact of obesity and metabolic disease on patients and health systems around the world.

Visit to learn more about Ethicon’s commitment to treating and reversing obesity and metabolic disease.
[i] More than 2.1 billion people—nearly 30 percent of the global population—are overweight or obese. McKinsey Global Institute
[ii]  114 million as referenced by the international diabetes federation
[iii]   MARS represents a comprehensive approach to developing an understanding of the mechanisms that drive the significant improvements in health associated with metabolic and bariatric surgery. Primarily leveraging preclinical models of these surgeries, the approach of MARS is to systematically deconstruct these procedures to understand how they work. This improved understanding provides insights into predictors of procedure outcomes and allows for the rapid and efficient testing of new treatment concepts in the preclinical setting. Successful therapies and predictors of success are then validated through clinical trials as we seek to improve existing therapies, as well as invent new therapies for patients suffering from obesity and metabolic diseases.

News from the Obesity Action Coalition (OAC)
About the OAC. The Obesity Action Coalition (OAC), a nearly 50,000 member-strong National non-profit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.

Obesity Action Coalition (OAC) Launches “Ban the F Word” Movement to end Fat-shaming.
Tampa, Florida—The OAC has launched a national movement – “Ban the F Word”—aimed at putting an end to fat-shaming. The movement is anchored by an online petition that individuals are encouraged to sign, pledging their support to raise awareness of fat-shaming and put an end to it.

“Weight bias has long been accepted in various areas of life such as healthcare, entertainment and more. With the rise of social media, a new trend has started in the way of fat-shaming. The goal of the OAC’s campaign is to raise awareness of fat-shaming and encourage the public to support our movement to end it,” said Ted Kyle, RPh, MBA, OAC Chairman.

With a membership of 50,000 individuals, the OAC is no stranger to addressing weight bias. Developed in 2005, the OAC has taken on high profile weight bias issues such as, fat-shaming apps, a Tennessee insurer’s IQ testing requirement for bariatric surgery, and ESPN’s Britt McHenry’s stigmatizing comments regarding body weight.
“The word ‘fat’ is most appropriately used as a noun. The fact that today we use it as an adjective and shame people dealing with the disease of obesity is highly unacceptable. As Chair of the Weight Bias Committee, I know individuals, especially children, are often targeted and shamed for their weight. Ban the F Word will raise awareness of this alarming trend and hopefully put a stop to its pervasiveness,” said Melinda J. Watman, BSN, MSN, CNM, MBA.

In April 2015, Ms. Watman appeared on CBS’ The Insider where she discussed how obesity is one of the last acceptable forms of public humiliation.
“Fat-shaming doesn’t discriminate based on race, gender or socioeconomic status. We encourage all Americans to stand with us and end fat-shaming,” said Joe Nadglowski, OAC President and CEO.


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