CINCINNATI, June 30, 2015 /PRNewswire-USNewswire/ -- Ethicon*, a leader in advancing bariatric and metabolic research for 20 years, today 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 obese1. We are calling our commitment, our rallying cry, It’s Time to Act on Obesity. And, if ever there’s a timea 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:
- 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 patients2 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 interdependencethat 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) data3 which shed new light on how bariatric and metabolic surgery works to improve conditions such as obesity and Type 2 Diabetes. Today’s 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.
Click here to learn more about Ethicon’s commitment to treating and reversing obesity and metabolic disease.
About Ethicon*
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for nearly 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com/obesity, and follow us on Twitter @Ethicon.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon* and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the activities described may not be realized; challenges and uncertainties inherent in research and clinical trials; changes to applicable laws and regulations, including global health care reforms; trends toward health care cost containment; and changes in behavior and spending patterns or financial distress of purchasers of health care products and services. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Ethicon and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.
Ethicon Worldwide Communications Contacts:
Michelle Parker
Office: 513-337-3590
mparker5@its.jnj.com
Ann Leibson
Office: 513-337-8180
aleibso@its.jnj.com
* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.
[1] 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. http://www.ethicon.com/healthcare-professionals/specialties/bariatric/metabolic-research/mars
[2] More than 2.1 billion peoplenearly 30 percent of the global populationare overweight or obese. McKinsey Global Institute
[3] 114 million as referenced by the international diabetes federation http://www.idf.org/BRIDGES/map/china
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SOURCE Ethicon
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