Ethicon, the Johnson & Johnson ($JNJ) unit devoted to surgical tools, is moving to defend its bariatric surgery territory as a slew of noninvasive medical devices to treat obesity line up to gain approval in the U.S. It will spend $3.2 million on more than 20 clinical trials to examine how early surgical intervention can be used to improve conditions such as obesity and Type 2 diabetes.
The trials are investigator-initiated and involve more than 2,000 patients across 5 countries: India, China, Brazil, France and the U.S. Ethicon expects the testing will help determine which patients benefit most from which specific procedures. It expects the resulting data could be used to justify expanded patient access to bariatric and metabolic surgery globally.
"We know that metabolic disease has reached pandemic proportions, as nearly 30% of the world's population is overweight or obese," said Ethicon company group chairman Michael del Prado in a statement. "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."
The trial financing is part of a broader obesity initiative that will also fund economic evidence that could help determine how obesity and metabolic diseases are treated. It also aims to work with governments to expand access to surgical intervention to more patients.
Ethicon sees each country as facing a particular challenge that it expects to help address in the clinic: Indian patients commonly may have a low BMI but may still have uncontrolled diabetes; in China there is a lack of bariatric surgeons and little legitimacy for obesity as a disease; the French lack consistent obesity treatment guidelines; Brazil has a 7-year long waiting list for bariatric procedures due to public funding restrictions; and in the U.S., efficacy of bariatric surgery in the treatment of Type 2 diabetes is a particular interest.
"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?" Dr. Elliott Fegelman, Ethicon's Medical Director for Obesity and Metabolic Disease, said in a statement. "In the U.S., 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 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 U.S., Asia, Europe and Latin America, all require different and distinctive solutions, and that's what our investment will help deliver," concluded Fegelman.
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