AGA Conference on New Technology and Innovation

Mark and Becky DeLegge attended the American Gastroenterological Association Conference on New Technology and Innovation. The conference was in Palo Alto, California and included physicians, entrepreneurs, venture funding specialists, regulatory authorities, payors and corporations. Dr. DeLegge opened the conference with a review of “Where We Are in 2011” in GI technology development, regulatory approval, reimbursement approval and commercialization. He used the company, Satiety, as an example of the current state of affairs. He also gave a presentation on the American Gastroenterological Association’s Payor Policy Group; a group that advocates for new medical technology reimbursement for the gastroenterologist from the payors. Dr. DeLegge moderated two exciting sessions, one in the area of obesity treatments and a second on how to get your new medical technology funded. Becky DeLegge met with a number of entrepreneurs and design colleagues and was a very sought after bioengineer and medical device development company CEO.

The conference presented many stimulating lectures. There was a tremendous amount of debate surrounding working with the FDA, creating the right business model, evaluating the clinical value of a medical technology and the value of partnerships in moving new medical technology forward. Next year’s conference promises to build on the success of this year’s conference. One area to be expanded is the presentation of new medical devices by physicians and entrepreneurs for feedback from this knowledgeable crowd.

Grand Rounds at Long Island Jewish

Dr. Mark DeLegge was an invited speaker at GI Grand Rounds at Long Island Jewish Hospital in New York recently. This conference was well attended by both pediatric and adult gastroenterologists, as well as GI fellows, medical students, nurses, dietitians and dietetic interns. The topic was “supplemental parenteral nutrition” and focused on the issues of hospital-based malnutrition, the impact of early enteral nutrition, the issue of gastrointestinal intolerance with the use of enteral nutrition with resultant undernutrition and the value of supplemental parenteral nutrition.

The audience was very interactive and there was a lively exchange about the lecture topic. Interest came up about the role of the gastroenterologist in both enteral nutrition and enteral access. The importance of a well-trained dietitian in guiding the nutrition plans of the critically ill patient was stressed. The plans for the formation of a Northeast Special Interest Group of practicing nutrition specialists were discussed. Dr. DeLegge received many thanks and accolades for the presentation. Afterwards, Staten Island Hospital was visited where a complicated patient at a hospital ready for discharge to a home parenteral nutrition service with CORAM healthcare was discussed. Everyone agreed that these types of complicated patients require a well-informed, well-communicating nutritional support team to manage the patient both in the hospital and at home.

Conflict of Interest in Today's Health Care Market

Conflict of interest (COI) has become a contentious topic in the medical world over the past two to three decades. The meaning of the term has become synonymous with dark connotations including greed, compromised, hidden agendas, sold-out and money-oriented. The true meaning of conflict of interest is really any scenario in which a party may have a personal interest in a decision being made by another party or group. This is in fact, a noble cause, and one that should be adhered to. We certainly do not want personal gain to influence how a decision is being made. On the other hand, it is unrealistic to expect people not to have conflicts of interest in medicine. This is especially true for physicians. In general, physicians as a group do practice medicine, but by their personal drive and nature, are often involved in other innovative initiatives. Some of these initiatives may be on their own, in corporate America, with physician societies, within a physician practice or within a hospital system. The idea behind conflict of interest rules is disclosure. Disclosure allows everyone to be aware of a conflict when a decision is being made, such that a party can recuse themselves. However, currently the COI rule is usually applied only to industry relationships, or personal business relationships. That is where the COI rules fall apart and are not applied equally across the board.

Here is an example: I work for my University’s Medical Center… I may be President of a specific medical association. If I advertise that I am president of that association on my CV or any other public document and it influences a patient’s decision to come to my University’s Medical Center for care as opposed to another, that is a conflict. If as the President, I am asked to speak at conferences because of that position and I am paid to attend, that is a conflict. If as a committee member of an organization, a physician writes a paper and that paper leads to him or her being identified as an expert in an area and then being compensated for consulting time, or attracting a research grant or more patients to his or her practice, that is a conflict of interest. However, these conflicts are part of normal life. It would be impossible to perform daily functions without them. On the contrary, if a physician serves as a consultant for a company, or runs his or her own company, then they are identified as having a “real” conflict of interest. In reality, there is no difference between the different scenarios I have provided.

Academic medicine, physician societies, physician practices and industry are all intertwined in the same objective – improving patient care. Most specialty societies would not exist if it were not for the funding of grants by industry, in addition to support of yearly societal meetings by renting vendor exhibiting space. I am sure some of these relationships have gone wrong; however I would venture to say that it is the minority of these relationships that have turned out bad. There is also a marginal number of times that researchers tell “fibs” about their data to get more research grants or health care systems protect physicians practicing sub-par medicine or physicians overprescribe procedures and testing to make more money. However, the majority do not behave in this manner.

I believe it is time for reality to set in and for physicians from “diverse” backgrounds to be linked together. Only with collaboration between academia, private practices, physician societies and industry can we truly look at major decisions from all perspectives. Declaring a conflict of interest is the right thing to do. Managing a conflict is imperative. However, having a conflict in one area should not eliminate a person from contributing, or even leading, if they have declared and acted on their COI sufficiently and with integrity. Conflicts of interest exist in all walks of life. It is the organization that realizes how to appropriately use all of their physician resources effectively and has “diverse” representation amongst their members and leaders that will be the ultimate winners. We owe that to ourselves, our patients and our healthcare delivery system.

Assessing Appropriate Parenteral Nutrition Ordering Practices in Tertiary Care Centers

Dr. Mark DeLegge and colleagues published in the January/February issue of the Journal of Parenteral and Enteral Nutrition an article titled “Assessing appropriate parenteral nutrition ordering practices in tertiary care centers.” This article and the research were partially funded by the South Carolina Research Consortium and the South Carolina Research Authority.

Parenteral nutrition is frequently used in the hospital environment because of “gut dysfunction.” However, parenteral nutrition requires a central venous catheter for infusion and strict monitoring of the patient’s metabolic status. Associated complications include bacteremia, sepsis, thromboembolic disease and liver failure. With that, it is recommended to start enteral nutrition (tube feeding) as opposed to parenteral nutrition if possible. Specific guidelines exist that recommend when parenteral nutrition is appropriate. One of these guidelines is published by the American Society of Parenteral and Enteral Nutrition.

This article described a study at four major South Carolina hospital systems. Over a three-month period, trained dietitians collected data on the appropriate ordering of parenteral nutrition at their facilities as determined by the American Society of Parenteral and Enteral Nutrition guidelines. It was noted that PN was inappropriately prescribed in 32% of the cases examined in the South Carolina facilities resulting in 552 days of inappropriate PN therapy at a cost of $138,000. This is consistent with data collected at an individual academic center in South Carolina that was reported in early 2000. If an institution had a nutrition support team that was actively participating in patient care, they had reported less inappropriate PN use. In addition, if an institution employed more certified nutrition support dietitians, they also had less inappropriate PN use.

Parenteral nutrition is a life-saving therapy. Its use can be extraordinarily beneficial. However, there are also risks and costs to the therapy that need to be considered. Appropriate use of parenteral nutrition therapy is imperative to improving clinical outcomes.

Dr. Mark DeLegge is the Director of the Nutrition Support Team and the Director of Nutrition at the Medical University of South Carolina. He is board certified in nutrition, gastroenterology and internal medicine. He has been a member of the American Society of Parenteral and Enteral Nutrition since 1989 and serves on their board of directors.

Intragastric Balloon Therapy for the Management of Obesity - Why The Bad Wrap?

Dr. Mark DeLegge and Dr. Joshua Evans (Fellow in Gastroenterology at the Medical University of South Carolina) published an article in the January/February issue of the Journal of Parenteral and Enteral Nutrition titled “Intragastric Balloon Therapy for the Management of Obesity. Why The Bad Wrap?”

In this article, it was pointed out that there could be a decline in the life expectancy of the U.S. population in the next few decades based on the epidemic of obesity. Diet and exercise can work to treat obesity, although the weight loss effects are limited and for a short duration in time. Surgery provides a more durable solution, but can be associated with major complications. The original endoscopic device for obesity was the Garron-Edwards intragastric balloon. However, at the time of its release in the 1980s, the device proved to be no better than sham controls in trials and there were associated complications of balloon deflation and small bowel obstruction. Because of this history, recent endoscopic techniques for the treatment of obesity focused away from gastric balloons and now included devices that allow intragastric stapling or suturing to create a reduced intragastric volume or a luminal sleeve that interferes with nutrient absorption. These devices are currently yet to be approved by the FDA and these endoscopic techniques can be endoscopically challenging to perform.

The simple concept and endoscopic technique associated with an intragastric balloon has evolved in the past few decades. Internationally, intragastric balloons have been shown to consistently result in durable weight loss over a one-year period. Although the weight loss may not be as significant as that which occurs with surgery, the overall cost of these procedures and associated morbidity and mortality are much less than a surgical intervention. A durable 10% total-body weight loss at one year has been reported, certainly markedly better than those reported with diet and exercise. Intragastric balloons would be a true “minimally invasive” approach to obesity. The right move in the treatment of obesity may be a step back to an endoscopic treatment – the gastric balloon.

Clinical Nutrition Week - Vancouver, B.C.

Dr. Mark DeLegge was in Vancouver, Canada this past week for the annual Clinical Nutrition Week conference. Participants were from the United States, Canada, South America, Southeast Asia, Europe and Australia. As a member of the Board of Directors for the American Society of Parenteral and Enteral Nutrition (ASPEN), Dr. DeLegge noted the outstanding science and clinical work presented at the conference. Major strides were made in the creation of a database that will track all home parenteral nutrition patients in the United States and to ultimately partner with other international physicians and countries. In addition, ASPEN will be supporting collaboration with the European Society of Parenteral and Enteral Nutrition (ESPEN) to conduct yearly surveys focused on the state of nutrition and nutrition interventions in our hospitals, sub-acute care facilities and long-term care facilities.

Dr. DeLegge serves as a board member on the Rhoads Research Foundation, a board dedicated to increasing funding for nutrition-based research. This board met in Vancouver and was successful in obtaining further long-term commitments from corporate and private donors.

While in Vancouver, Dr. DeLegge participated in a roundtable discussion with a number of patients receiving tube-feeding at home and their families. He was able to problem-solve some issues they were having and was also able to learn more about what impact tube-feeding has on patients who are receiving enteral nutrition at home. He has received an award in the past from the Oley Foundation, a support group for home parenteral and enteral nutrition patients, for “extreme volunteerism.”

Dr. DeLegge was also a speaker at the conference and addressed the topic of gastrointestinal intolerance during tube feeding. This is a common problem and can result in patients not receiving adequate nutrition at home. This lecture was well received by a number of U.S., Canadian and international clinicians and was noted by a few at the conference as being “exceptional.”

Next year’s Clinical Nutrition Week is in Orlando, Fla. DeLegge Medical has made plans to be there with their new “enteral access” line.

AGA Clinical Congress and Hands-On Course - Miami, Fla.

The American Gastroenterological Association (AGA) held their recent Clinical Congress in Miami. The event was well attended, the programs offered were diverse and South Beach was as always, entertaining.

Dr. Mark DeLegge chaired and moderated the Practice Management Course. This course described to physician practice leadership the “coming” role of Accountable Care Organizations and Health Care Reform on the practice of gastroenterology in the United States. Dr. DeLegge also lectured in this forum on the future of endoscopy in ambulatory surgery centers, hospital outpatient endoscopy suites and office-based endoscopy facilities with the advent of healthcare reform.

Dr. DeLegge also co-chaired the AGA practice skills workshop, a forum for gastroenterology fellows plotting out their future careers to understand the career opportunities available to them in academic medicine and private practice. With his career experience in academic medicine, private practice and hospital leadership, Dr. DeLegge’s primary message was “find a mentor and listen.”

There was also a hands-on-endoscopy course offered for the first time by the AGA. Course attendance was completely booked and Robin Murray from DeLegge Medical assisted the AGA in putting on this inaugural course using table-top models and ex-vivo pig stomachs and intestines. Experience was received by attendees from “expert endoscopists” in the areas of tissue ablation, stenting, micro-endoscopy and endoscopic mucosal resection amongst other topics. Robin organized a first-rate course that was a smashing success. The new “pig trays” that were unveiled by Robin were very versatile and created a “real life” endoscopic experience.

DeLegge Medical is committed to excellence in physician education and the development of new medical technology. We are continuously exploring the means to put the right tools into the physician’s hands with the right training experience to ensure procedure success and patient safety.