81 min reading time … what is the implication to the medical device industry? To the economics of healthcare? From TIME: “Treating obesity as a disease implies … moving from a body-mass index (BMI) of 29 to a BMI of 30, is equivalent to contracting a disease. But that is simply not the case.” The Washington Post: “We should hope that labeling obesity a disease can at least change how America trains doctors to treat it.” Forbes: “The American Medical Associationâs announcement … terrible news for food companies, public health advocates, and … obese Americans.” And “calling obesity a disease gives a hall pass to many who either donât care or who struggle with their food and lifestyle choices.” Also from Forbes: “Obesity IS a disease, a chronic, frequently progressive, and rarely remitting disorder that triggers an additional 65 or more other conditions….” The New York Times: “There is not even a universally agreed upon definition of what constitutes a disease. And the A.M.A.âs decision has no legal authority.” Will “obesity as disease” have any impact on your business? How? ++++++++++ As an experiment, let’s see if we can’t help some members connect with a hiring company. Irvine, California-based Kareo (medical office software and services) needs a Director of Marketing Communication with success at a technology company, most likely B2B SaaS. They need a CTO and another half dozen roles filled. It would be great to fill these roles with Medical Devices Group members, donât you think? Good luck! http://medgroup.biz/Kareo ++++++++++ Discussions To Discover: Device Tax: Is 3M being audited? The Reasons Why Medical Startups Fail How to find distributors in Latin America? ++++++++++ Happy Independence Day to the 59% of the Group that celebrates it! Joe Hage On the blog: The dominant meddev marketing tool http://medgroup.biz/marketing-tool Bernadette Silva Nadine Lepick I agree with Mark Hollingworth that there are many different reasons for gaining weight. Sometimes, one only needs to look at what is specific to the things they’ve been doing to find the root cause. Of course, we in any medical field are going to look at this as a problem and try to provide help. That is what we do. Erica Heath, CIP “Summary: Guy Hibbins Paul M. Stein Burrell (Bo) Clawson Stephen Glassic I think the medical device and healthcare industries are already benefiting financially due to the increased need of treatment for diseases and conditions brought on by obesity. It is hard to say what the effect of reducing the prevalence of obesity will have on them in the future. It may just shift healthcare needs in a different direction. There will probably be no magic solution. Obviously, it will take a multifaceted approach including changes in society, the food industry, farming, biological science, healthcare, fitness programs etc. Since it developed over a long period of time, it will take a long time to change, therefore the medical device industry and hospitals will continue deal with and profit on the effects of the obesity for quite some time. If we are successful at reducing obesity, it should have the effect of reducing the cost of healthcare in the long run. There may be some opportunities in the medical device industry to produce devices to help with reduction of weight, or weight, diet and exercise management. I also think healthcare organizations, employers and health insurance companies must take a proactive approach in the promotion and management of weight loss, diet and fitness initiatives. If the cost of medical care keeps rising with the issues of aging baby boomers, obesity and it’s collateral health effects along with all the other current healthcare concerns and issues, it could become cost prohibitive and unsustainable. I think it is imperative to devise a public health initiative to aggressively promote healthy weight, including measures to make restaurants and the food industry become more responsible in providing disclosure and more healthy ingredients and offerings and communities, employers, health insurance companies, fitness professionals and health providers teaming together to help promote health conscious habits and guidance. Patrick Kullmann Stephen Glassic Clara Chung Guy Hibbins This is especially true in rapidly transitioning economies like India and China. The cost in terms of health dollars and in human terms is enormous. The so called diabesity tsunami is doing a lot of damage already. I think that the most innovative solutions will be the best rewarded. How about a treadmill with its own inbuilt TV/WiFi internet/DVD capability. Paul M. Stein Clara Chung Gary Abramov Gary Abramov Pete Bobb Leanna Levine Gary Abramov Leanna Levine Gary Abramov 6y Weight Maintenance diet Zucchini Peppers, green 1 med. raw red onion calories in 3 ounces squid calories in garlic 2 teaspoons Tomato Pasta Sauce, 1 cup 5 small strawberries Olive Oil Unsweetened tea Total for Sunday Brunch meal 343 Calories Diner Tomato, large Olive Oil Total for Sunday diner 269 Calories Snack 1/4 cup macadamia nuts Sunday total: Monday Brunch Tomato, large Olive Oil Total for Monday brunch Monday Snack 9 Blackberries Olive Oil 1/4 cup macadamia nuts Snack total Monday dinner Tomato, large Peppers, green Smoked salmon Olive Oil Total for Monday diner Monday total: Burrell (Bo) Clawson BMR measurements are typically taken in a darkened room upon waking after 8 hours of sleep; 12 hours of fasting to ensure that the digestive system is inactive; and with the subject resting in a reclining position. I just don’t believe anyone can gain on 800 calories a day, except a young child. That is like 2 muffins a day. I had a friend who said he had a very low caloric intake, but then he noted he went through a six pack a day plus his chips, so there was another nearly 1000 calories. Pete Bobb Burrell (Bo) Clawson Urs Mattes David Pennington, PE Guy Hibbins Stephen Glassic Everyone’s circumstances are different, therefore their approach to weight reduction will depend on their physical limitations, biological circumstances and mental commitment. It will require a tailored and flexible plan (which may include progressive diet changes, physical therapy, medical procedures and exercise) as well as a long term commitment. There will be stumbling blocks along the way. The other underlying problems will have to be dealt with appropriately and with each progression, or if there is a setback, a reevaluation should be done to determine further action. Some people will progress faster than others and some will probably be faced with failure along the way which may or may not be overcome. I think it is time for the medical community to step up and develop a team approach with doctors, nutritionists, physical therapists, and fitness coaches to tackle this issue by providing an individualized approach. Hopefully the medical device, pharmaceutical and clinical laboratory sectors will come up with the tools that will aid in managing this type of program. This is a very important (I would say Number one) issue since it is a catalyst for so many other medical issues. I think the device industry would be wise in making sure their developments are poised to become one of the tools rather than the total answer. Paul M. Stein Fred Voss While I agree that the current intragastric balloons do have a number of issues and are certainly limited to short term use, they do however assist some patients and have had some good success. Other transoral esophageal approaches such as GI Dynamics endo sleve, Enteromedics Neuroblocking, as well as a host of endoscopically delivered space altering and surgical assist devices will all have a place to treat the great numbers of individuals that are most at risk for complications as defined by their clinical condition. There are a few companies that are developing and/or have entered the market recently with ingestible devices and approaches that can be delivered without endoscopic assist. These approaches may allow bariatric space feeling therapies to be made available to the 10’s of millions of individuals who are obese or overweight and clearly pre-diabetic by objective testing criteria. These approaches have the hope of being pill-like in delivery without the potential issues of pharmaceutical risk. We are developing one such device as has Obalon, Gelesis and a Canadian Academic under the name of Eat Little. Paul M. Stein Paul Teitelbaum Interesting points. I also wondered myself, after writing that comment, if the recent AMA announcement might alter Allergan’s thinking. Will be interesting to see what happens. I have heard that intragastic balloons have been having some challenges or questions about the approach, but could not recall the details. Also I am aware of an early stage endoscopically-placed technology that seemed quite promising to me when I looked at it a year ago. They secured some funding from one of the F500 device companies, but things have been put into hibernation since there has been a restructuring at the F500. I wonder if with the recent developments, some technologies might be dusted off and re-invigorated. ReShape is just one of many interesting products in the obesity space. Keep looking, and you’ll find much, much more out there besides balloons. Paul M. Stein ReShape is just one of many interesting products in the obesity space. Keep looking, and you’ll find much, much more out there besides balloons. Fred Voss Unfortunately Allergan has been now looking for a buyer for the Obesity product area for the last six months or so. http://articles.latimes.com/2013/feb/05/business/la-fi-mo-allergan-earns-20130205%7Cleo://plh/http%3A*3*3articles.latimes.com*32013*3feb*305*3business*3la-fi-mo-allergan-earns-20130205/MOTV?_t=tracking_disc] âIt is very odd, if not concerning, when a company wants to unload its once prized product,â said Dr. Amir Mehran, board certified bariatric surgeon and Medical Director for the Bariatric Surgery Center of Excellence. âIt makes one wonder if they are concerned over long term side effects of the device (as is now being seen overseas), and they donât want to be owning it once that happens in the U.S.â http://bariatricsurgerymd.com/examining-pending-allergan-lap-band-sale%7Cleo://plh/http%3A*3*3bariatricsurgerymd.com*3examining-pending-allergan-lap-band-sale/SDOa?_t=tracking_disc] However, even this should not dissuade the medical device industry from moving forward to develop improved devices for the diagnosis, primarily of risk factors, and therapies for those who need to control their weight. One such company ReShape is currently in clinical trials for an improved Intragastric Balloon system. If successful ReShape will have the first FDA approved gastric balloon in the US since the early 80’s. The ReShape system, as well as other Intragastric Balloons, are approved and marketed outside the United States. It will be interesting to see if Allergan reverses course on the divestiture of the obesity product area with the recent AMA decision to classify Obesity as a disease. Paul M. Stein In addition, 14M people classified as obese are Medicare-Medicaid eligible. With the AMA declaring obesity as a “disease requiring treatment”, legislation and insurers will move more rapidly to approve various treatments, as it is in the best interest of everybody. For anyone with a successful design, I am personally not worried one bit about profits immediately or tremendous reimbursement in the future. Burrell (Bo) Clawson There is a difference from what is defined by Joe’s references and Medicare & Insurer’s decisions as to what they will cover & what CPT code, if any, would apply. If we design a new, much better product, there is no guarantee we can get a reimbursement allowed, much less allowed at the price we want to sell the product. We can do our best work in product design and still have one heck of a time getting profitable. Paul M. Stein David Arndt Maurice Coates Burrell (Bo) Clawson If you don’t get the young, you don’t instill values. We see it throughout society. Richard Jeffery In a lot of northern European countries they are building homes and apartments with ceiling hoist track already installed as standard part of homes and with universal adapters available on hoist systems so you can install a hoist for wide range of solutions and provide a true home care solution for a variety issues. Jagu Barot Nadine and Rochelle, Imagine Home Health Care nurse going on a visit of a 300 lb patient trying to move him or her in the bed. Need a hydraulic lift which is not issued by any medical agency. In the hospital you can at least summon a crew. But Home Health care Nurse? Heavens help. Rochelle Froloff, R.N. Nadine Lepick Louis DePaul The cause of obesity might be argued, but unless someone has developed the equivalent of a perpetual motion machine that generates calories, at some point, reducing calories consumed or increasing calories burned should work. My observation is that much of medicine is about treating symptoms and not the cause, and certainly not the cure. Ken Kasper Glenn Neuman Diets influence the microbial balance, with and without anti-microbials. Rochelle Froloff, R.N. Burrell (Bo) Clawson 1. People “work” less when given the choice: less exertion = less fit–low burn rate. The large issues of human nature pervade the entire society we are in. Madison Avenue then found they could use human nature to sell us things we otherwise wouldn’t buy. Canned vegetables rather than the better ones we can grow or buy fresh much of the year. Science “comes to the rescue” with many good solutions, but also leads to things that can harm as we have seen. We need some mineral “elements” (aluminum, strontium) in micrograms per day and they are critical to human health in the right amounts. On the opposite side of Science are “preservatives” and “anti-microbials” that are added to foods & condiments of all types to keep them fresh for months rather than refrigerated. Micrograms of these “anti-microbials” must also affect the (guess what) microbes in our own digestive tract. That means we might be altering the balance of microbes into ones which cause adverse effects on people. Evidence is building that upsets in the digestive tract (the engine that powers you) may be behind many medical conditions including the rise of undesirable bacteria & viruses that lead to diseases including obesity if you want to call it that. Some bacteria break down food into more easily digested different components than normal. Human nature being what it is, including denial, even though the bathroom scale says otherwise, means we have a very tough “row to hoe”, because no one is doing any “hoeing” anymore. Rochelle Froloff, R.N. Sent from my iPhone Fred Voss An excellent summary and a fitting close. I had similar thoughts for a final statement but you have stated the points that need to be said. Fred Paul M. Stein Rochelle Froloff, R.N. Marc Hollingworth Pete Bobb Gary Abramov Pete Bobb Mike Rauch Lindsay Webster John Abbott Burrell (Bo) Clawson Jagu, it would be a winner for the doctors, except that the government winds up both defining the disease under Medicare rules and then defining how little the doctor will get paid to treat the disease. Medicare has inherent conflict of interest positions that make it unviable as a sustainable organization and yet WDC politicians want nothing to do with changing it. If you are on a 10 mile road heading for the edge of the Grand Canyon traveling at 60 mph and the throttle sticks and you can’t shut the engine off, everything is still fine until … Well, the politicians say to themselves, “I’ll be dead by the time Medicare reaches the edge, so I’m not going to stand in front of the train and get run over.” Meanwhile everyone wants to pretend they &their families are going to be riding the Orient Express with luxury service forever … right? Stephen Glassic Over the years we have acquired more devices and gadgets that help us to get things done with less physical labor in an effort to accomplish more in a shorter period of time In factory jobs, there are computers and machines that do the physical aspects of the work. Even farming has evolved to the point where much of the work is done with computers and machines. Now, on the horizon, there is the possibility that our brain will be connected to a computer so we only have to use out thoughts to perform a task. There are things like the Segway to move from place to place without walking. Will it eventually get to the point where our brain will control them too? Our bodies are part of who we are as a species and we cannot physically evolve as fast as these things becoming available. We need to continue to use our bodies because it is a part of who we are. We cannot survive as a species by exercising our brain alone. We need to maintain our bodies in order to maintain the health of our brain. This is a very complex issue and there are many other contributing factors that have been brought up here. I hope that in regard to medical devices that will be developed to address various aspects this issue, that they first and foremost provide real solutions without costing an arm and a leg. This problem (pardon the puns) is so massive that if it isn’t addressed practically, it could be the straw breaks the back of the healthcare system. Jagu Barot So, now the doctors and the taxpayers are responsible for individual personal excesses. It is understandable if there is a genetic abnormality or a thyroid abnormality beyond the individual’s control. Otherwise, the individuals must take the responsibility for their weight control. Hammer it down the heads of the kids in their formative years. I see doctors as the winners with obesity promoted to a disease–one more way to make more money. Glenn Neuman Realistically, where’s the role of education? And physical education — I had it every day in school — every day. Now, kids don’t have it at all. They work out their thumbs on the gaming console and their cell phones. Corrective action looks insurmountable, but preventive action is education, and that we can do, for the long term. Angelique Lynch Gary Abramov Angelique Lynch Fred Voss The 89 individuals are on the pre-season starting roster of the San Francisco 49ers football team. The men are extremely fit and have great stamina in order to play in the NFL. The results of the obesity in this case are minimal during their playing years due to this work regimen. The NFL and the teams are very serious regarding the procedures that they have put in place to prevent obesity complications. In May of this year a player on the New England Patriots was released because he was diagnosed with type 2 diabetes. Now that is serious workplace discipline. The team and the league have not disclosed the regimen that is undertaken in order to allow these excellent results. I would suggest that the players, besides being on strict dietary regimens and exercise (obviously), have a number of guidelines that including periodic screenings. In these screenings is most likely: Quarterly or semi-annual HbA1c In addition, a test for non-alcoholic fatty liver disease (NAFLD) is warranted in the most severely obese players. Fatty liver represents an inappropriate fat storage by the liver and is a marker for more serious complications. The presence of NAFLD is currently best determined by MRI scans. There are no IVD tests but some visualization is possible with ultrasound. I am not well versed in scanning technology, however, if an innovative company can come up with a device, presumably ultrasound that is tuned to detect NAFLD it would be a significant advance. The ability to screen millions of obese individuals and alert them to this issue could be most lucrative and life-saving. A final note, the NFL has a workplace program they call Q5 that is for retired players. Q5 stands for quarter five and represents the time after active playing. This program, among a long list of other non- obesity related assistance, is intended to ensure that the obesity required for the job is well controlled and that players manage their health and lose the weight necessary to avoid complications. Apparently this works well and could be emulated by companies and health insurers. Pete Bobb Guy Hibbins I was surprised to see comments that obesity was not an appropriate topic in a business forum. Well medical devices are part of the healthcare industry, which treats diseases, including obesity, however they might be classified. Erica Heath, CIP Pete Bobb Fred Voss I will wait until later this evening to see if we get other comments and then describe the work environment and situation. Erica Heath, CIP What would I do? I would ban any eating at their desk or on the job and, if possible, I would require that they leave their work area for the duration of their lunch period. Burrell (Bo) Clawson Fred Voss The following represents the BMI distribution for 89 individuals that work for a company. These are real numbers and real people. Classification Number Fred Voss I am not a physician and this advice is offered only due to your obvious concern regarding your situation. I would suggest that you discuss this with your physician and if he/she is not receptive to the discussion find one that will discuss this with you. Joe, this is way off topic however it may serve to illustrate a point. Unfortunately the condition in which you find yourself is not unknown. You have not given us your BMI but it could be anywhere from 20 to 45 with the same situation. Yes folks there are normal BMI individuals with prediabetes or full blown type 2 diabetes. Here is a suggestion determine your post prandial (after eating) blood glucose levels. Measure your glucose one hour after a meal. If it is above 130 or so you have an issue with response to carbohydrates in meals. These high post prandial spikes can and do result in elevated HbA1c levels and are signs of insulin resistance or poor beta cell (insulin producing cells) response to glucose. Try different carbohydrate sources and determine your post prandial glucose, you may see a pattern. I would also suggest that, whatever your current BMI may be, you begin a more strenuous exercise regimen and attempt to lose some weight. The problem we are seeing in the world, sorry for those who like to point to the indulgent US population, this is not restricted to the US but is a worldwide issue. The human species has a complex and diverse genetic makeup. One of the features of this make up is the processing of food and the metabolic response to ingested food. There are some in this thread who out of ignorance and/or spite believe that because they have no problem with weight or diabetes then others are simply indulgent, gluttonous, sloth or any other derogatory term you can find. While this is perhaps true in some cases it does not represent the majority of the tens/hundreds of millions of people worldwide who find their bodies responding inappropriately to our modern food supply. Like it or not humans have developed modern methods of producing great quantities of food at reasonable prices that has fed the world. This is in contrast to the dire scenarios of my youth that suggested we would be faced with world wide starvation as the population continued to increase. Unfortunately for human biology this abundance has come at a price. The easiest and cheapest food that can be produced are grains containing high concentrations of carbohydrates and these are used in almost all of our foods. Combine that with food processors who have learned how to make processed foods more appetizing and we have an epidemic. One last comment, within the genetic makeup of the species in which we all find ourselves is great variation. One of those variants are individuals who do not process food well and have to eat larger quantities to obtain the energy for life. These individuals in our current situation seem to be able to remain thin without concern for their diet and are often admired for their thin bodies. Fortunately we will never have famine and world wide starvation, however, if we did you would be the first to go. People could say how lazy you were to not go out and work harder to find food for yourself. Interesting discussions. Pete Bobb Paul Teitelbaum John Minarovich This is a multi-faceted issue that crosses the boundaries of psychology, physiology, culture, agricultural abundance, genetically altered foods and I would argue evolution at a slower pace than our technological advancements With regard to the original question, obesity being designated as a disease, perhaps now the medical community will put some thoughtful and intelligent assets to work on a comprehensive method of addressing the situation â hopefully more curative than treatment oriented. Perhaps this is an opportunity for the genomic experts to shine. Jennifer Ahlstrom In my opinion, this is absolutely NOT true in all cases; maybe not very many cases, at all. I am a reasonably intelligent (in my opinion, anyway) professional with a degree in biology, and by the age of 43 had had gallstones, a stroke, high cholesterol, thyroid issues, and ovarian cancer. I NEVER understood (and my Dr. never explained to me) just how my poor eating habits and being overweight most likely contributed directly to the various disease conditions I had until I started doing some of my OWN research and found information about how fat cells, inflammation, stress, hormones, etc. all interact (as Pete Bobb has been talking about up-thread). Now that I DO know more (which still isn’t very much) about this, I understand just how much of a part I may have played in contributing to my own poor health and am working- on my own- to hopefully reverse those years of neglecting my health. But my Dr. never explained it- they only said (and just once or twice in the 5+ years I was going to them) ‘you might think about losing some weight.’ Never WHY, or WHAT the connection actually WAS. Not all that helpful, in my opinion! To address the problem long-term, I think doctors will have to become more nutrition and behavior focused and actually spend some time TALKING to their patients (gasp, the horror!) about what specific lifestyle issues they face that could be contributing to their diseases, and how to overcome them, instead of spending 10 minutes with them and tossing a Rx at them now and then. (And I do agree that agri-business and their $$ play a very large role in putting all those tasty, unhealthy foods front and center, too.) I understand that this group is business-focused and that this ruling could open the door to companies capitalizing on the obesity ‘epidemic’ but as a human being, I do hope medical device and pharmaceutical companies work to truly HELP people in addition to just making money from them. Leanna Levine Everyone here who understands something about the biochemistry of obesity, seems to suggest that it controls the body, is irreversible, and we should pity people who can’t help but consume 5000 -10,000 calories or more a day. The biochemistry seems to suggest that obesity is actually a more natural state. Given vast quantities of readily available food, we can’t help but become obese. The genetics drive us to eat more than we need. The ill effects of overeating can’t be helped except with drugs, diagnostic devices, and surgical procedures. People who are obese shouldn’t be expected to know how to make better choices for themselves, they are driven by their biochemistry. As many people have commented here, the medical industry has been offered many new opportunities for making money by leveraging the need for a myriad of new products required to manage everything from simply moving these patients from one place to another, to developing new drugs to combat the altered biochemistry of obesity, creating products we didn’t need 30 years ago. We are busy building hospitals with larger doors, beds, rooms. Obesity is great for business. Let’s applaud this new opportunity and get busy writing business plans. After all the social issues that underpin the national pastime of eating are far too complex to tackle, its much easier to find ways to invest in a new pill and a new gadget to monitor it and control it in an objective way that decouples personal choices from medical consequences. Clark Celmayster That being said “Harmony” may be a reason as to why so many do not take their conditions (whatever they may be) seriously enough to do something about them! Self prevention (and preservation) would alleviate many of the healthcare problems we face and reduce the rising costs we all face. “Zen” will not fix the problem and it takes more than being coddled to make people realize they need to address their self created afflictions and addictions. For some the end result of being, feeling and looking healthy may be enough of a reward, others may find that some other kind of reward might work, but many more may need stronger methods to force them into a healthy life style. If I had the real solution I would be sitting on a yacht right now, however there is obviously no silver bullet, other than people taking responsibility for their actions and if they don’t, be willing to suffer the consequences without asking others to suffer along with them. This is the malaise of not just health and healthcare but of society and our changing culture in general that needs to be realigned before it is too late. Obesity is just one issue of many… Mark McCarty Clara Chung Clark Celmayster This may seem cruel but for those whose issues are due to their own fault, just like committing a crime, there need to be consequences that are significant enough to make them change their lifestyles, since how they (and often by example their children) look and feel aren’t seemingly enough. Airlines are starting to charge people for 2 seats if they are too obese to fit into a normal seat. We do not (YET) have the government underwriting that additional expense, so why should the tax payers who are fit pay the price for those who are not? Bottom line is it is time for people to stop looking for excuses and think about how their actions impact not only themselves but everyone else! Stephen Glassic In many ways, medical devices are already being implemented in hospitals, medical centers and emergency response to deal with overweight people but it seems reasonable that with the declaration of obesity as a disease there will be a need to come up with a tailored approach to weight management which could pave the way for new methods to monitor the progress of patients at an individual level in a day to day approach. I think the door is opening for devices with Aps that have the ability to monitor a variety of biological indicators and patient activity in an ongoing basis with the capability of being tailored to the individual, including a reasonable diet, activities etc. based on the capabilities of the person. Of course this should all be monitored by specialists who work closely to tailor and tweak the program in order to produce results. If these devices could also be used for other purposes and eventually become an overall health monitor that can be tailored to all the individual health concerns of the individual and connected to the appropriate data systems and health management teams with a timeline of individualized data. They could also be used to manage various implanted devices. Many people who are overweight do not believe it is a problem at first or don’t think there is a solution to the problem and/or they are unwilling and sometimes unable to make the changes in their lifestyle in order to achieve results. There are many diet plans, exercise plans and pills on the market but most of them fall short of achieving lasting results or in many cases no results at all. Therefore it is not uncommon for people to jump from one approach to another and then to another looking for something that will magically produce results in a short period of time. It is possible some of these things, in combination with a managed program, could achieve good results. But it must be understood that it has to involve a long term and lifelong commitment from the individual and results will be gradual. It usually takes a long period of time for someone to become overweight and it will undoubtedly take a long time to reverse it. The changes in diet and lifestyle must be tailored to the individual and gradually changed over a period based on what the person is willing to commit to and able to achieve. Very often there is also other physical and biological limitations that will also have to be taken into account, especially in older individuals. Anything that can be done to address other limitations must be done. I think it is time for hospitals and medical clinics to set up departments that specialize in physical health and weight management. Maybe they can also partner with health clubs to produce prescribed and monitored programs for each individual. But it will take a lot more than that to get our population in better shape. There has to be a multifaceted cultural drive to incorporate healthy choices in our lifestyle and diet. Many of us don’t get enough physical activity in our workplace or our daily lives and we don’t have the time or ability to prepare healthy meals and choose quick (often unhealthy) alternatives. Our culture must be reorganized to include time for healthy activities, healthy (and more importantly) properly proportioned meals at the right time of the day. How about a program where employees get paid to exercise (based on their abilities) and the insurance company provides a discount or credit to the employer to cover a certain portion of the cost. If it is managed well, the employer will probably see a certain amount of increased productivity and less employee downtime. The FDA must also become more diligent about what is allowed (or not allowed) in our processed foods based on scientific studies performed by truly independent sources. Sorry Joe, that I got off on some tangents but this topic is very conducive to that. Paul Teitelbaum Clark Celmayster There are those that will blame our endocrine system, society, fast food companies etc. for obesity, cigarette companies for cancer etc. however though they play a large role as the providers of our addictions, the bottom line is that we all understand the harm we do to our bodies by smoking, eating poorly and the bad lifestyle choices we make,etc. Granted, eating a more healthy diet is not the only way to overcome obesity. We need to exercise more, get off the couch, get outside and become more active. Instead we take pills, purchase vibrating belts, get liposuction or stomach reductions, etc., i.e. taking the laziest and least effort generating means to address the root causes of many of our health problems. Until we change the growing mentality of people blaming others for their poor lifestyles and take responsibility for our own actions, we will continue on this downward slide of personal health, increased costs of healthcare and more opportunities for our government to feel like they need to take control of our lives at every level, through the creation of a nanny state, because we are increasingly proving them right, that many of us are unable govern our own lives. The definition of insanity is doing the same thing over and over again, expecting a different result and based on that statement It would seem that we have a growing % of our population that need to be committed! HOWEVER, then the AMA would classify all of our bad lifestyle choices as a Mental Disease!! OOOPS.. I may have opened another can of worms..Can You Deep Fry Them Please? Paul Teitelbaum There are not many that are approved and currently marketed in the US – it might only be the Lap Band by Allergan, which is actually pondering selling the business. But there are a number in development and we are compiling that. Can you pass this on to him and have him ping me? Paul Teitelbaum Clara Chung Joe Hage David Lim just started a related conversation at http://bit.ly/obesity-product-list%7Cleo://plh/http%3A*3*3bit.ly*3obesity-product-list/x1lg?_t=tracking_disc]. He’s hoping we, as a group, can list the medical devices currently addressing the obesity market. Can you help? Pete Bobb Fred Voss Joe A meeting would be interesting. The medical device industry has been steadily supplying the needs of the increasing obese and overweight populations of the world for the last 40 years and this is certainly going to continue. With the classification of obesity as a disease we will see more attention to the direct treatment of obese and overweight individuals instead of the treatment of the longer term complications. Both the medical community in terms of physicians, nurses and other care-givers will be more likely to put aside the many biases and begin honest discussions with patients regarding their conditions and potential treatments. We have two issues, prevention and treatment. Both of these need significant effort and the medical device industry needs to play a role in both. On the prevention side better tools to monitor food intake and project weight gain in terms of both smart device apps and IVD’s will be important. Unfortunately many individuals do have different metabolic and social situations that make these types of tools important. On the treatment side we need to find ways to assist the 10’s of millions of individuals who can be staged as having or developing serious complications. This effort requires more than simple diet, exercise and social engineering approaches. Better diagnostic tools to identify those most at risk as well as better devices to assist in weight loss that recognize the inherent metabolic and psychological fight to prevent starvation even when one is obese are needed. The treatments will come from a variety of existing, developing and hopefully novel medical devices. The medical device industry has been working on less invasive bariatric surgical therapies for the more severely affected super obese individuals where the condition is life threatening. For others in the overweight/obese categories less invasive technologies are being developed and the funding for some of these efforts may be more available. There are plenty of opportunities and in my honest opinion the recent classification of obesity as a disease makes these opportunities even more compelling. Ronel Jessen Joe Hage Now that obesity is a disease, what is the implication to the medical device industry? To the economics of healthcare? And Paul Teitelbaum wrote me and suggested we have a meeting/conference as a medical device industry on obesity. Would that be of interest for you? If the stars aligned (cost, timing, location, availability), would you attend? John Abbott My problem is that I just don’t get it. I am 6 feet 178 pounds and over 60. If I gain 5 pounds I feel bad. I exercise regularly and I eat less. I occasionally stop by my favorite burger joint and I (gasp!) eat ice cream and potato chips. So maybe I am not qualified to comment… Guy Hibbins Gary Abramov So, here’s a ‘radical’ (not really) idea, to answer some of the questions raised here regarding treatment/sessation: just like an alcohol-sessation program, make food unpalatable for these people. This can be done via the food itself (poi-only diet, anyone?): a very temporary solution, since the people will go on a Twinkie binge right out of the ‘bland’ therapy, or by disabling reward/pleasure pathways to/in the brain, starting with the taste receptors (probably the easiest to anesthetize anyway): the action can be extended/reversible or even made permanent (for ‘repeat offenders’). The efficacy of this approach is, unfortunately, proven and is right in front of us: geriatrics with diminished/lost sense of taste are rarely (never?) fat (uh, sorry, overweight, in our aseptically paranoid PC lingo): for them food lost its sensory attractiveness, and they eat for its energy content only. Very sad indeed, but, in this context, effective. The same goes, again, very sadly, for cancer victims: frequently they stop eating and lose (a lot of ) weight. I’m convinced that anything less will fail sooner or later, since for the obese people the love of food has often replaced all other pleasures in life, including sex. Since very few people will give up the pleasure of sex (last time I checked:), the same goes for the love of food: abstinence/surrogates (go hungry/”eat your veggies” instead of sweet/fatty/salty instant pleasure stuff), don’t/won’t work either. It may work for a while, but people will revert to the ‘real’ (for them) thing. This very dynamic is a rule rather than exception for a majority of ‘weight-loss’ programs, including some surgical procedures.People make lots of money even by merely discussing these ‘yo-yo’ effects: just look at the mags in the checkout line at the supermarket. Urs Mattes Joe Hage 59% of the Medical Devices Group resides in the United States. Paul Teitelbaum Fred Voss “Philip, it may be a chicken or egg issue, but I suspect that most overweight people also have hyperinsulinaemia as well as elevated levels of neoglucogenesis.” The data for metabolic syndrome indicates that the combined overweight/obesity category has greater than 60% of the individuals without hyperinsulinaemia, 50 Percent of Overweight and 1/3 of obese are free of metabolic syndrome issues. With 1/3 of ‘normal’ weight individuals having metabolic syndrome it clearly is not a simple correlation. With regard to the comments regarding obesity as a US issue the current information suggests that the fastest increase in obesity is occurring in China. In part due to better living conditions and in part due to the one child per family situation that has resulted in a generation of very pampered children and young adults. Is this becoming more US like, the question exists! Finally the rise in type 2 diabetes around the world as reflected in projections from the year 2000 to 2030 show that it is not only the US diet as one commenter suggested. Projected increases are: (number in millions base year 2000 – projected year 2030) The reference and graphic is posted on by facebook page.. I will echo Mark’s comment above. What are we going to do tomorrow to make a difference? Paul Teitelbaum Angela D. Hollen Angela D. Hollen David Pennington, PE Paul Teitelbaum Marc Hollingworth C. Angelique Steccato ACO stands for Accountable Care Organization, but what about Accountable Care Organism “human beings”. Think McDonalds in the early days, there were no “Value Meals” “SuperSize” or “Designer Drinks”, how many Americans eat more processed foods laden with fat, salt and preservatives this generations over last and last over prior. Add to that refrigerators for keeping our wine chilled, our vodka in the freezer, etc. The fact is that Americans want a “Pop a Pill” “Cut and Remove” solution, weight is not put on overnight and is not removed overnight with long lasting results, unless a true behavior modification plan is put in place post procedure. I feel for those whose weight issue is due to genetics but take a look around, HPB, Diabetes, Heart Disease are not the norm in countries where the “Mediterranean” or other type of diet is prevalent. Angela D. Hollen Last point: in general, hospitals must have a special approval for caring for obese patients. Everything from larger beds, devices to move larger patients (to decrease risk of employee injury), larger commode chairs, larger rooms and restrooms, specially-trained staff to manage all of these during patient use, etc. It is not at ALL surprising to me the cost of obesity, and where it is heading. Pete Bobb Marc Hollingworth Paul Teitelbaum Sharon Kohanna (prev. Murray) This is on par with the recent update to the DSM IV [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition]. It contained a Bereavement Exclusion which allowed people a period of six months after the loss of someone meaningful in their life to have feelings or behaviors associated with grief be regarded as normal and not diagnosed as a mental disorder. The new DSM5 has changed that and now allows that within two weeks of a death of someone important to them, patients who mention having feelings of sadness, confusion, etc, relative to that death, can be diagnosed as Major Depressive Episode [MDE] and be given prescriptions for psycho-pharmaceutical drugs.âŠsee more Jim Carr Leanna Levine What would happen if the price of a bag of potato chips were the same as the cost of a healthier choice that was vegetable-derived and fresh? The balance is tipped way in favor of grabbing a bag of chips than a bag of veggies just from economics that is driven by subsidies for production. But if government got out of agra-business and the real cost of grain production were realized, perhaps people will make different choices based purely on economics, both from the viewpoint of what the grocer puts on the shelf, who can afford to offer more veggie products because the price differential is less, and for the consumer. I wish conservatives would focus on eliminating all the government welfare that goes to business which contributes much more to screwing up our economy and our health than any program that serves the ‘little guy’. The problem is, the big ag producing states are represented largely by republicans, who would get run out of office if the touched any of these issues. We’ve only gotten fat since the advent of government subsidized agra business. The big issue I see with calling obesity a disease is the cost to business because now people can claim disability due to the disease obesity that somehow limits their ability to perform a job. That worries me as a business owner. As a citizen, it seems that once you call something a disease, a person is now able to forfeit any personal responsibility for their health. Its a disease, its out of their hands. The lack of personal responsibility and accountability seems to me to be the biggest disease affecting our country. Regarding Obamacare or the alternative of our current extremely expensive and broken system; until we all wake up and demand accountability from hospitals and other institutions providing healthcare for the cost of healthcare delivery, we will continue to swirl in this quagmire. As a society we seem to have lost the concept of personal responsibility and accountability. What if we all knew what the cost of having a by-pass surgery BEFORE we needed it? Couldn’t we shop around for the best deal? What if we all knew what was included in the cost of a one day hospital stay? There isn’t any other service that we pay for where we are not provided costs upfront. Why is everybody so content to let someone else negotiate these prices? Do you really need an insurance company to do that? Why can’t the consumer do that? No one can navigate the current system as an individual, and that is WRONG and has created the non-competitive marketplace we have. I wish we were truly a republic that was run by citizens for citizens. Marc Hollingworth Burrell (Bo) Clawson I know some upper income families that never have a home cooked meal unless it is chili from the crockpot, so it is NOT economic in some families. It is mental. Maybe the effect of very highly specialized psychologically studied & oriented marketing from the bowels of focus groups and other very professional Madison Avenue advertising programs has figured out how to push the high fat, high calorie food items to become “the norm” for many people because it is easy to make lemmings out of them with things they find that taste good. It is all done for the sake of profit on legitimate products. Then we have to get back to how do parents and schools teach and train kids. The ads start teaching kids what to eat almost or sometimes before their parents do it, if they do it at all. Then we have to ask should TV even be allowed for early years of life. The nanny state can then fight with Madison Avenue over who gets the bucks. Marc Hollingworth Paul M. Stein Jean Bigoney, PhD, RAC, CQE Just FYI, I am considered “overweight” according to most weight tables for women. Evidently whoever publishes these tables don’t consider the possibility of a middle aged woman lifting weights and having a much higher percentage of muscle than average. I don’t let it bother me in the least. Again I realize that there are people who are overweight, even seriously overweight through no fault of their own. However, I see people leading a sedentary lifestyle. I see them driving their kids 1/2 mile to a school bus stop so the kids don’t have to walk. I see peoepl consuming insane amounts of soda. I see on TV the mothers feeding their obese children homemade chocolate covered donuts for breakfast (Jaime Oliver’s food revolution). Pills are not going to help those people Paul Teitelbaum Burrell (Bo) Clawson I think Obamacare is going to be the biggest albatross around the neck of this country we have ever seen. I don’t know what is going to happen to it, but it will fail, but in WDC, that means it just gets “changed.” Cost is ultimately what causes individual people to change habits. When they run out of money, they are forced to change. That could mean they are taxed out of available funds. All in all on a business side, though, I have to agree this will create a boon in both products and services. Some of them will be very good and help people, but ONLY if they adopt new healthier lifestyles. That is tough. How tough? Well, the last number I saw said we have 120 million or so people with STDs in the U.S. Alcohol and “recreational” (debilitating) drugs are another biggy. Paul Teitelbaum Paul M. Stein Burrell (Bo) Clawson About 40-50%, depending on how you count it, have illness conditions caused by personal choices and actions. Hence the other 50-60% are going to pay the price of healthcare for the other people who don’t want to minimize or eliminate their bad personal choices. An example, the obese people I’ve known myself that fall down because they don’t have the strength and balance to manage normal walking. One person I saw was so far gone that when he fell down, he could not get up by himself. When the government offers to do everything for everyone, the people who do a normal working life are going to get the shaft in taxes to support those, about half who do not choose live a healthy life. Eventually this will create a crisis. Insurance was to always from the beginning of Lloyds of London meant to assess risk and charge appropriate freight insurance. If you had a new ship, you paid less premiums than an old tub. Today “health insurance” has become corrupted as it is now just a form of give-away from the government when premiums have little to nothing to do with risk. Without incentives to stay healthy we get what we have and where we are going…toward a collapsed system eventually. You can’t bleed society at ever growing rates of taxation before one form or another of collapse occurs. Paul Teitelbaum Paul Teitelbaum Pete Bobb Jean Bigoney, PhD, RAC, CQE I don’t remember where I saw it, or perhaps I was talking to a friend in the device industry abotu some pill that big pharma has come up with. They weren’t targeting seriously obese, even though morbid obesity can be life threatening; instead they were targeting the borderline obese because the market is bigger. I was not kidding about the stunt big pharma pulled with “pre-hypertension” by the way. In 2003 they labeled it a “disease,” big pharma profited to the tune of about $16 bil a year, and in 2012 a Cochrane study on nearly 9000 patients showed NO benefit of “treating” these patients in terms of reduced risk for stroke or cardiovascular events. It would seem that the panel of 11 “experts” (nine of whom were consultants to big pharma) slipped up on that little distinction between correlation and *causal* correlation. Looks like they get to play the same game now with patients who can not or will not make lifestyle choices to reduce their weight. And I understand that not everyone who is obese is themselves the cause of it. But I am convinced that if it were a matter of treating only those patients who are obese through no fault of their own, the market is not big enough to make big pharma sit up and take notice. Want ideas for a medical device for treating obesity? How about a spoon with a big hole in it? Or substitute a pair of cross-country skis for that snowmobile, or hiking shoes for Pete Bobb Guy Hibbins Fredrik Kaestner Mark McCarty Rochelle Froloff, R.N. Mark McCarty You act like obesity doesn’t happen without Madison Avenue and modern food processing. Care to back that up with studies of other populations across place and time? Tom M. Richard Jeffery Red is no, yellow is a some times food and Green is go for it but we have fast food and soft drink manufactures saying no way with lots of money and clout. The cost to society is huge and health budgets are stretched and often they do not have enough money for bariatric beds and products let alone address work place safety issues eg a standard toilet can only support 180kg. So these are problems but they are also opportunities from room fit outs, through to equipment and treatment. Will this go the same way as tobacco and we now have plain packet for all tobacco products with extreme graphic of what happens if you smoke that we have here, probably. Talking to Prof Paul O’Brien from the Monash Obesity Centre states there are no magic pills on the horizon that FDA are likely to approve in the near future and since the US is the driver of these products and he has been working both here in Australia and the US for the last 20 years.I think he is some one that is great reference point. So I see is opportunities as peoples health, lifestyle and age decrease and we are in the perfect position to assist. Bonnie Trefny-Scilingo Andrea Robles Erica Heath, CIP I understand that this is not a political discussion but, just fyi, I took greater offense at the dig about contraceptives being free under Obamacare. For a long time with many insurers Viagra was covered and contraceptives weren’t. How fair was that? I wasn’t going to comment on it but it seems that the idea in that talk about being open to other points of view might apply to this as well. Joe Hage Professor Jean is back! Paul M. Stein One of the other very popular treatments for obesity, the vertical sleeve gastrectomy, uses several thousands of dollars of linear staples (Covidien, J&J) per procedure. Performed over a million times per year, you do the math. So, be blind and criticize away at anyone and everyone, but in this $65+B market, the promise of medical devices will provide untold riches for some very sharp inventors and those investors who see an opportunity when it slaps them in the face. Jean Bigoney, PhD, RAC, CQE Hanna MĂ€hlen Mark McCarty If I had to guess, I’d guess the AMA announcement does little more than add fuel to the debate. There’s still a need to define obesity, and a need to factor in interaction with co-morbidities. Then there’s the issue of evidence of effectiveness of interventions, which CMS and private payers are going to eye very carefully. Anyone care to take a stab at how “reasonable and necessary” will play out here? Up next are registries and coverage with evidence development. At the risk of seeming to pretend there are no FDA-approved treatments (and I hate to sound like a doubting Thomas), but this whole discussion has a long, long way to go if you ask me. Burrell (Bo) Clawson Just for reference, my legs are 3 inches shorter than my brother and that alone puts me over the edge on the BMI index, just because my legs are shorter. Don’t know that WTH index is better. Jennifer Ahlstrom There absolutely ARE reasons- outside of poor lifestyle choices and people being in ‘denial’ about their condition- that people ‘end up’ obese. Debilitating health conditions that do not allow them to exercise and metabolic disorders that affect their weight negatively are just a couple of them. People who live in ‘food deserts’ with NO available choices for unprocessed, healthy food is another, as is living in conditions lacking the equipment necessary to cook healthy foods even if they DID have access to them. Obesity is a very complex social AND medical problem, without a simple answer. I do agree that the ‘standard’ BMI measurement isn’t very good, and hope that isn’t what the medical industry ends up choosing to use as a basis for whatever they do propose. Rochelle Froloff, R.N. Rochelle In a message dated 7/2/2013 2:41:25 P.M. Eastern Daylight Time, Joe Hage Maybe it’s not as easy as (your words) “the problem [lying] with the person who is obese and is in denial and continually makes poor choices in their lifestyle.” David Branscum The BMI has a lot of holes for diagnosis of obesity. For example: I am obese. I am also 6’1″, 215 lbs, at 14% body fat. I can also dead lift twice my body weight 3 reps at the gym. I am not obese. Depending on the doctors definition, maybe I need pills? Maybe I don’t, but I know someone who wants them for recreational purposes? Obviously I would never do this, but it contributes to the higher cost of healthcare which affects my personal bottom line. I would love to hear the perspective of a member that provides devices for lap band, etc. Anyone? Rochelle Froloff, R.N. Joerg Schulze-Clewing Marked as spam  Posted by Asked on August 16, 2012 12:14 pm 101 views |
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