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Walking the Line: Ethical Engagement with Industry
inflammation. Multiple approaches to control and modify the inflammatory reaction in chronic rhinosinusitis have led to many new agents being introduced topically to the nose. This mini-seminar aims to provide an evidence-based approach to the science behind topical management of sinonasal disease. Current research into irrigation dynamics and delivery device will be discussed. There are a range of products available to deliver solutions topically to the nose. The scientific basis behind high and low volume along with negative and positive pressure delivery is presented. The general therapeutic goal of topical management often lies between potentially competing actions of mechanical and pharmaceutical intervention. Distribution research behind nebulizers, sprays, irrigations and other delivery techniques is discussed within this framework. The over-the-counter (OTC) market for topical sinonasal treatments is likely to exponentially grow over the next few years. Increasingly, the pharmaceutical options have also grown. Antibiotics, such as mupriocin, and steroids are often added to solutions. The science behind the OTC agents and pharmaceutical additions to saline are presented. Potential adverse risks also need to be balanced with greater local intervention. The influence of pre- and post-surgical distribution efficacy is an important factor that significantly changes how these solutions should be used. Saline, as the basis of all topicals, and its evidence base are briefly described. A special component will be included on novel therapeutic agents, delivery techniques and nanotechnology. Emphasis will be both on what is available today and currently research only. The miniseminar is presented by rhinologists actively involved in the topical management of chronic sinonasal conditions both clinically and in research. Presentations for delivery, device, saline and pharmaceutical additives will be given with video used to illustrate research. EDUCATIONAL OBJECTIVES: 1) Define the therapeutic goals of topical therapies. 2) Understand the influence of device and surgical state on topical delivery. 3) Learn about the science behind novel topical agents.
Walking the Line: Ethical Engagement with Industry Anand Devaiah, MD (moderator); Ofer Jacobowitz, MD, PhD; Udayan Shah, MD, FAAP; Gordon Siegel, MD; Gina Smith, JD PROGRAM DESCRIPTION: There is increasing pressure on Academy members balancing interactions with device and drug manufacturers, the need to maintain corporate funding sources to support research and educational efforts, and greater public scrutiny. This interactive course is intended for physicians considering or involved with industry relationships (nondisclosure agreements, product development, and speakers bureaus). Recommendations will be made which maximize patient benefit from new products, minimize legal risk, and
P19 optimize physician involvement and compensation. The concept of ‘risk tolerance‘ will be reviewed as will processes for safe and ethical evaluation of devices & drugs. We aim in this one-hour presentation to empower participants through awareness of regulatory and criminal risks of malfeasance and fraud, by didactic slide-based format using case law, current examples, sample contracts, and audience participation. Participants are encouraged to bring case studies for interactive discussion. Panelists include physicians experienced in device and drug development, intellectual property concerns, a venture capitalist engaged in health care investments, and a health care litigator who served as a Prosecutor for over 18 years. EDUCATIONAL OBJECTIVES: 1) Engage in productive, long-term collaborative relationships with industry. 2) Ethically engage in optimizing patient care, innovation, and compensation for work done. 3) Understand available resources for addressing controversies and concerns.
What You Want to Know about Meaningful Use: Stimulus Plan K J Lee, MD (moderator) PROGRAM DESCRIPTION: On February 17, 2009, the American Recovery and Reinvestment Act was signed into law. The Act sets aside $17.2 billion in incentive payments under CMS to eligible professionals and hospitals for meaningful use of electronic medical records (EMR)/ electronic health records (EHR) technology. This miniseminar will not only identify meaningful use, but will also discuss how to implement meaningful use without disrupting physician and staff work flow. Since meaningful use is a work in progress, according to Dr. David Blumenthal, National Coordinator for Health Information Technology, we hope to get constructive ideas from the audience on how to help the smooth transition to, and the implementation of, Meaningful Use. Time will be allocated for Q&A. EDUCATIONAL OBJECTIVES: 1) Identify meaningful use stimulus plan. 2) Implementation of meaningful use without disrupting physician and staff work flow.
When Politics Interfaces with Medicine: Effective Advocacy Denise Sherman, MD (moderator); Gerald Healy, MD; David Kennedy, MD; Harold Pillsbury, MD; David Nielsen, MD PROGRAM DESCRIPTION: There are many challenges in the healthcare environment as fewer patients can afford insurance in this current economic recession and the cost of health insurance for those who can afford it continues to rise. Otolaryngologists are faced with more patients who are unable to comply with treatments, both medical and surgical, as well as follow-up appointments. However, the government is looking
MINISEM.
Miniseminars
Walking the Line: Ethical Engagement with Industry Anand Devaiah, MD (moderator); Ofer Jacobowitz, MD, PhD; Udayan Shah, MD, FAAP; Gordon Siegel, MD; Gina Smith, JD PROGRAM DESCRIPTION: There is increasing pressure on Academy members balancing interactions with device and drug manufacturers, the need to maintain corporate funding sources to support research and educational efforts, and greater public scrutiny. This interactive course is intended for physicians considering or involved with industry relationships (nondisclosure agreements, product development, and speakers bureaus). Recommendations will be made which maximize patient benefit from new products, minimize legal risk, and
P19 optimize physician involvement and compensation. The concept of ‘risk tolerance‘ will be reviewed as will processes for safe and ethical evaluation of devices & drugs. We aim in this one-hour presentation to empower participants through awareness of regulatory and criminal risks of malfeasance and fraud, by didactic slide-based format using case law, current examples, sample contracts, and audience participation. Participants are encouraged to bring case studies for interactive discussion. Panelists include physicians experienced in device and drug development, intellectual property concerns, a venture capitalist engaged in health care investments, and a health care litigator who served as a Prosecutor for over 18 years. EDUCATIONAL OBJECTIVES: 1) Engage in productive, long-term collaborative relationships with industry. 2) Ethically engage in optimizing patient care, innovation, and compensation for work done. 3) Understand available resources for addressing controversies and concerns.
What You Want to Know about Meaningful Use: Stimulus Plan K J Lee, MD (moderator) PROGRAM DESCRIPTION: On February 17, 2009, the American Recovery and Reinvestment Act was signed into law. The Act sets aside $17.2 billion in incentive payments under CMS to eligible professionals and hospitals for meaningful use of electronic medical records (EMR)/ electronic health records (EHR) technology. This miniseminar will not only identify meaningful use, but will also discuss how to implement meaningful use without disrupting physician and staff work flow. Since meaningful use is a work in progress, according to Dr. David Blumenthal, National Coordinator for Health Information Technology, we hope to get constructive ideas from the audience on how to help the smooth transition to, and the implementation of, Meaningful Use. Time will be allocated for Q&A. EDUCATIONAL OBJECTIVES: 1) Identify meaningful use stimulus plan. 2) Implementation of meaningful use without disrupting physician and staff work flow.
When Politics Interfaces with Medicine: Effective Advocacy Denise Sherman, MD (moderator); Gerald Healy, MD; David Kennedy, MD; Harold Pillsbury, MD; David Nielsen, MD PROGRAM DESCRIPTION: There are many challenges in the healthcare environment as fewer patients can afford insurance in this current economic recession and the cost of health insurance for those who can afford it continues to rise. Otolaryngologists are faced with more patients who are unable to comply with treatments, both medical and surgical, as well as follow-up appointments. However, the government is looking
MINISEM.
Miniseminars