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Kerri Miller (host): The Food and Drug Administration has not okayed a diet pill in a long time. Side effects like heart problems and birth defects had kept many of the medications off the market but today the agency will turn to a panel of doctors who a reviewing the medical data on a drug called Qnexa, it's a medication that was rejected by the FDA in 2010. The doctors will make a recommendation later this spring to the FDA. Our question today as the obesity epidemic rose in America how are medical experts weighing the risks of diseases like diabetes and heart disease against the risks of weight loss medications when we know that many Americans gain back the weight that they have lost are medications key to permanent weight loss? Our guests are going to join us in a moment, but I want to hear from you. Have you ever used medications to help you lose weight and if a new drug was on the market how much would you work about side effects if it meant that you could lose a significant amount of weight. Tell me a bit about your experience with medication and weightless and if there was a new drug approved on the market how much would you worry about the side effects if it meant that you could lose a significant amount of weight? Our guest this hour is Dr. David Katz the founding director of Yale University's Prevention Research Center and he is with us from New Haven, Connecticut. Dr. Katz thanks so much for the time today.

Dr. David Katz (guest): My pleasure Kerri, thanks for having me.

Miller: Simone French joins us she is a Professor of Epidemiology at the University of Minnesota Public Health and she is an expert on the issue of childhood obesity and she is with me in the studio. Simone welcome good to have you here.

Simone French (guest): Good morning Kerri.

Miller: Dr. Katz let's talk about what the FDA is doing today in just a moment but I want to come back to this idea of balancing the consequences of obesity against the potential side effects of a medication and I wonder if you sense that the FDA has a renewed interest in that?

Katz: I do clearly Kerri and by the way it's a pleasure to be on the line with my friend Dr. French. Really the issue for the FDA always is to look at the drugs in context. Everything in medicine involves potential risk. But for instance if you are looking at treatment for a life threatening cancer the notion that some breakthrough chemotherapy would involve some potentially quite serious risk is acceptable because the risk of non-treatment is no high. So the issues are always what's the tradeoff between the risk and benefit, what else is available out there? In the obesity case and before we are done I will tell you I am not enthusiastic about drug treatment for obesity but we can start by acknowledging we haven't go much and in terms of pharmacological therapy we have got nothing that is safe, effective, and reliable and we have epidemic obesity as one of the gravest public health threats of our time. You know we have surgery, bariatric surgery, but that's pretty drastic in its own right and there's no question that the FDA's question to reconsider Qnexa which they had looked at and rejected before is in context. WE don't have much of anything; we have a very serious problem on our hands. Is it possible that even thought this drug isn't terrific that the tradeoff between risks and benefits still favors its approval that's how they are thinking?

Miller: So Professor French I thought we would break that down just a little bit more. Here's what the company that is making Qnexa said in the documents that they originally submitted. "The ability of Qnexa to produce durable weight loss can be expected to contribute significantly toward ameliorating some of the consequences of obesity and weight related comorbidities." I mean that's a lot of language there but they are essentially arguing what we are asking this morning right? That if there are side affects you still get enough of a benefit from losing the weight that that ought to be considered. What's your view of that?

French: Well I think that there's only one drug that's FDA approved for weight loss and that's Orilstat and I agree that having options out there for people are important. That would be something that we would want to see options out, but just to put a context on this we do have a broad range of available approaches for overweight and obesity ranging from behavioral approaches which are mostly education and behavioral change approaches up to pharmacotherapy and then as Dr. Katz mentioned bariatric surgery. So each of those approaches might be appropriate for different people with comorbidities and different levels of overweight and obesity and these drug trials and drugs might be appropriate in my option for morbidly obese people with very severe obesity problems and maybe even a subset of those people might be helped. Individuals might respond to some of these but again even the trails that have been examining these drugs in morbidly obese people still see only a small subset who have good results from those so I think that even from a public health point of view so drug treatment of obesity really isn't an approach you would consider from public health treatment and that's 70 percent of the U.S. population. But from a clinical point of view helping find approaches that might help people who are severely overweight and whom behavioral approaches have not worked well that might having additional drugs out there might help a small group of clinically obese people who have health conditions but I fear that because you know people translate these approaches down into the general population of these people like bariatric surgery now being considered for adolescents and that blows my mind. That's something that you would never even thought about before and I don't think it's appropriate so when the drug treatment issue comes up you just worry that that will be translated down to the people who have a BMI of 26 or 27 and that we wouldn't want to see. I think a behavioral approach would effective in those types of people.

Miller: I want to talk to you a little more about that. But Dr. Katz is that why you are concerned about the wide spread potential use of drugs and people that don't really need it as Professor French is talking about.

Katz: Well actually Kerri that's only one of my concerns and in some ways perhaps the lesser one because I don't think people with lesser degrees of obesity are going to rush out and use drugs particularly on their children where people are at. Although I quite agree we have seen expanded uses of bariatric in younger people and frankly it's because our population is desperate for something that will work for weight loss. My concerns are that if we turn to pharmacotherapy for obesity we are trading the cost of obesity for the costs of the drug. I don't think it solves the economic problem but I think it's just fundamentally decided and to sort of situate this we have epidemic obesity because we eat too much and do too little we are sort of fish out of water. We were designed for a world where calories were relatively scarce and hard to get and physical activities was unavoidable and we devised a modern world where physical activity is scares and hard to get and calories are unavoidable. I compare that to a fish out of water. Now if the fish gets and infection you can put antibiotics in fish food and treat it but if the fish is flopping around out of water imagine trying to design a drug to fix that. It's a profound distraction from the obvious problem and that's really my biggest concern here. The longer we think, and I quite agree by the way with Professor French that there is a limited role for pharmacotherapy for drugs in severe obesity in medicalized cases, but the notion that pharmacotherapy is going to ameliorate obesity as the drug companies suggest is dangerous. It is dangerous because it is like thinking that we can design drugs to help polar bears survive in warmer climates or fish survive out of water when the real answer is to restore a healthy environment and the longer we fiddle around with pharmacotherapy I think the longer we spend not looking at the problem which is all around us and creating environments where being active and eating well lie along a path of lesser resistance. And of course there is the fact that the drugs themselves are not terrific. Qnexa is a mix of two drugs, Phentermine and Topiramate. Topiramte is an anti-epilepsy drug and side effects include things like brain fog and confusion and nausea so this is not a free ride and phentermine is a stimulant I don't think it surprises anybody that stimulants can cause weight loss. Frankly cocaine can cause weight loss but that doesn't make it a good idea so we have just about no evidence that people can safely take this drug for the long term and we have abundant evidence that when you stop taking a weight loss drug you gain back the weight. So the real issue here is that this is not an effective solution.

Miller: We are talking in depth this hour about the FDA's reconsideration of a new diet drug, talking about the risks of that whether it's some of the side effects, how they balance out with the benefits, clear benefits of losing weight. I'd like to hear from you this hour. Have you taken medication to lose weight? How did it work for you? And what if there was a new drug on the market but you were concerned about side effects, how would you reconcile that? We are in depth on diet medication and lets turn to the phones to Steve in Minneapolis, Hi Steve I appreciate you waiting.

Steve (caller): Thank you. I am 58 years old, I'm a truck driver and I have a family history of diabetes after 50 and I was on former drugs for weight loss before and I just finished the process for bariatric surgery. If I had a choice again I would probably do the pill because I only have 65 pounds to lose and I had good success with the pills and I'm not really crazy about doing the surgery which has some risks also.

Miller: Steve may I just ask you one question. What about the side effect of the pills?

Steve: I didn't have any side effects and I think even with the bariatric surgery there are side effects to that as well also. More so for women than it is for men but there are side effects and there are actually people that die from the surgery so I think it's kind of gone on equal grounds in my mindset but I'd rather take the pill. I don't get much time to exercise driving fourteen hours a day in my type of situation I'd like to protect my job and do it with the pill instead of the surgery.

Miller: Yeah, I appreciate the call. Professor French it sounds like medication, bariatric surgery, there are going to be side effects and this brings us back to what you were saying earlier bout what you were saying about exercise and perhaps behavioral help with this yes?

French: Well we just did a study on bus driver so I empathize with the situation of being in a seat all day driving as part of your work. It is hard to get physical activity in that kind of work situation. I don't know if the caller had tried behavioral weight loss programs and for some people those work and for some people they struggle and try that for years and years and so then they want to try something that might work for them when behavioral approaches have not worked. So in the callers case maybe the drug therapy which seemed to work well, I'm not quite sure why he moved up to the bariatric surgery, and not going back to those drug therapies.

Miller: Can I ask you this? Have methods in the cognitive therapy for weight loss, have they evolved much or have they changed or is what we knew about this I don't know thirty years ago what we do today?

French: Well they have evolved and we are learning more and more how to tweak those more and more to make them work even better but a standard behavioral approach the treatments that have been evaluated by research studies have lengthen and the standard approach is six months of weekly meetings and the techniques have been shown to work and they produce about ten percent of initial body weight loss after about a year of treatment and the techniques that are learning don't cost money, you don't have to buy drugs and they help you develop skills that in your environment that you are living in you can help make better choices and enlist support and look at your environment and know what triggers you to eat and in what circumstances. All of those are skills that you can learn and apply in your daily life and they don't cost much.

Miller: Here is somebody on twitter reinforcing what you are saying, "no pills, no shortcuts, weightwatchers is the only thing that ever worked for me." I mean that's behavioral therapy right?

French: Yep, food, exercise, and having group support to learn and manage this obesigenic environment that we all live in. I completely agree with Dr. Katz that the big thing staring us in the face is our environment and our lifestyle in the way that our world is set up and that's why 70 percent of U.S. adults are overweight or obese. That's the big then but then when you step back from that well we can work on changing policy and the environment at the individual level on these behavioral approaches but for people where that is just not working or if they are genetically more susceptible we found actually the increase in prevalence of obesity has been higher in the upper end of the distribution so some people who may have a genetic susceptibility to our toxic environment are having super-duper effects on their obesity in the high end so this environmental effect is causing everybody to get overweight but among the susceptible its even magnified for people like that I can see how surgical and medical approaches might be entertained but for the vast majority and if those options get the news and they are detracting from the policy and support for environmental change then I think that's a draw back. But I don't think that relieves us from the responsibility for looking at our environment and trying to look there for solutions.

Miller: Dr. Katz what do you want to say about that?

Katz: Well I also empathize as again we have noted that the modern environment where physical activity is scarce and hard to get and nowhere more so when you are doing a job that requires you to sit all day. So for one thing we need to engineer solutions to that and Steve I commend to you when you get a chance when you're not driving take a look at abeforfitness.com these are free fitness videos you could put on a handheld device you could do them at truck stops. Actually what we are working on physical activity you can do isometrics while driving with an exercise using the steering wheel. One of the things we in public health need to do is talk about the behavioral approaches and facilitate them. I agree with Professor French that the behavioral approaches have evolved, many of us have been working on that and weight watchers is effective, it is a very good program, but even that can be enhanced. It can do a better job of reaching families; it can be tailored better for men. We have been focusing in our work on something called impediment profiling where identify for you the specific values in Steve's case it would be stuck in a truck all day to being physically active or specific values as eating well and help trouble shoot those. In terms of Steve's advocacy for using a drug he is basically saying I was staring at the options of surgery or medication and I'd like to have the medication option. I think we agree with him, I think that's why we can't just boycott the position of what the FDA is doing today. There are going to be severe cases of obesity or cases of obesity where behavioral solutions don't stick, don't work, the person can't do them, they have tried and failed, whatever the issues may be where the consequences of not treating the obesity effectively are greater than the risks of the drug or the surgery and then frankly what you are comparing is, and I think Steve nailed this, the risk of surgery versus the risk of the drug and absolutely there are important solutions for both. We do need to be very careful however, and I'll reemphasis that this particular drug Qnexa contains Phentermine which is an amphetamine like drug, it is a stimulant and that's not safe to take for the long term. One of the things it can do is drive up your blood pressure which is one of the very metabolic complications of obesity we are trying to prevent. And I think it is also important to note that the history of drug treatments for obesity serves up one precautionary tale after another. From my perspective a far more promising drug than Qnexa was Rimonabant. I think that was the most promising weight loss drug to come along.

Miller: And what happened to that?

Katz: Well it was never approved in the U.S. because of fears of psychiatric side effects because when you start tweaking pathways in the brain you get unintended consequences. It was approved in Europe and they also ultimately withdrew it there as well because of an increase in the rate of suicide. So again we are talking about playing around with fundamental pathways in human metabolism and there is real danger sometimes not originally seen there. We have not been very successful to date with drugs for weight management.

Miller: Let me grab a call here from John listening in from New York. Hi John I appreciate you waiting.

John (caller): Hi, Thank you I love the program. I am very curious as I am thirty now and when I was eighteen I experiment with the Xenadrine during its phase of being allowed over the counter and I had you know increased heart rate obviously that went along with it and I got off of it basically because I was having dizzy spells and I fainted in basketball practice and knew it probably wasn't the best for me. It did help and I lost thirty pounds you know I had tons of energy and numbers of friends my age that took it an had success you know we were younger and didn't have problems. Then the whole craze came out about what Xenadrine was doing and it got lopped off and we were obviously weren't taking it but it kinda caused a stir much like this weight loss drug and my question is if you watch the nightly news on any of the major networks every other commercial is something for erectile dysfunction or COPD and the list of side effects, and crazy side effects are longer than the commercial shows in the content of the commercial so I am wondering why is it a weight loss drug would cause such a stir if very common things such as heart medication and lung medications, you know I've had problems with Prilosec and Omeprazole with side effects that have caused panic attacks and depression and these seem to be all of the craze and have been for decades I mean what's the answer to that?

Miller: Dr. Katz what's the answer to that?

Katz: Well a couple of things, it's always an issue of the trade off so there is the inconvenience in the case of something like erectile disjunction is the effect on quality of life of the condition versus the side effects of the drug. One thing to note about those commercials, every possible side effect must be listed pretty much and that doesn't mean they are likely or common. In the case of a drug like Phentermine an elevation in blood pressure is very likely. In the case of Topiramate in Qnexa the likelihood of nausea or brain fog is pretty high. So some of those side effects on the TV commercials could happened but hardly ever do. We are talking about side effects that can be potential very serious and happen often. But I think frankly the bigger issue is efficacy. We are really not just talking about side effects, we are talking about the tradeoff between the effectiveness of the drug ad the side effects of the drug. All of the side effects on the TV commercials for heartburn or erectile dysfunction they work. Again the evidence at the population level the drugs are effective for causing weightless and keeping th weight off just isn't very good and so if the effectiveness is not great and there are side effects that are potentially dangerous when you look at the risk benefit trade off it becomes very questionable. And then again my critical point for this discussion is that obesity really is different from the other things we use drugs to treat. You know fish can get sick and you can treat it with a drug but if a fish out of water needs to be put back into water you wouldn't treat that with a drug. The obesity epidemic really is about the environment all around us. We can fix it there but the more we think about using drugs to do what we should be doing with programs and policy the longer we delay and I think that's really the gravest danger here of all.

Miller: We are in depth here this hour if you have just tuned into the Daily Circuit on diet medications. The FDA is actually turning to a panel of doctors who are reviewing a drug that had earlier been rejected, re-reviewing this drug Qnexa for consideration of a diet medication. Sue Stein writes on Facebook "I have tried pills for weight control in 1966 and they didn't work and the side effects were awful. I've tried weight loss candy, weight loss drinks, and hypnosis and 500 calories a day, nurse supervised diets, weightwatchers twice, calorie counting. All have failed. Professor French I'd like to talk to you about I think this is something you have raised about excessive eating and some of these medication that target appetite control but I think you would say that much of the excessive eating, we have talked about the environment but some of this is emotional eating in response to what, depression or emotional problems?

French: Well people eat for a variety of reasons as well all know I mean personally I don't eat because I'm hungry all of the time or stop because I'm full, I'm influenced by my setting, my habit, when the mealtime happens to be if its lunch or breakfast, if there is food in the room. We get influenced in our eating and food choices by a variety of social cues and contextual cues and emotional cues so the drugs that are targeting hunger mechanisms and safety mechanisms grated those mechanisms do contribute to food intake and regulation but there are so many others and part of the reason that the environment influences we have been talking about had such a big impact on eating and weight is because those influences are real and they are strong and constant and so not that many of us just eat in response to hunger and stop when we are full so we are not that in tune with things and also there is a significant group of people who are more responsive to emotional eating. So people vary in how responsive they are to different influences on their eating maybe some more people are more responsive to biological feelings of hunger and there is another group that eats less when they are upset. I mean there are a variety of people out there and some have argue that introducing, going back to the drugs, that operate on different mechanisms because we have this big individual variability in reasons for eating and in our biological make up that having more choices out there would be a good thing. I mean so that's one argument, but it's true that the other point that has been raised that I just wanted to make is the cost benefit ratio of some of these drugs. I agree that this needs to be looked at and we don't have great data that some of these drugs really do produce lasting weight loss that is better than behavioral approaches. A good behavioral approach produces ten percent of weight loss after treatment and the most recent trial that I was looking at of Qnexa in the literature showed the high dose there was a high medium and a control placebo group, the high dose lost ten percent after a year so go figure. If you could get people to adhere to the behavioral program maybe that's another issue maybe these morbidly obese people can't adhere as well as an overweight person who doesn't have such a severe problem.

Miller: Dr. Katz you wanted to add?

Katz: Yeah if I may jump in, one other thing you introduced Simone as a childhood obesity expert and that's a focus we share, I'm actually the Editor in Chief of the journal Childhood Obesity and a lot of my effort is directed there as well because the earlier you intervene the greater the opportunity to improve quality of life for the whole life span and just stop for a minute to think about whether or not everybody in a family who is prone to obesity and maybe already experiences it at different stages is going to take the drug. Is there a his and her version and dad, mom and the kids? One of the things that a pharmacotheraputic approach ignores is that the basic functional unit of our society is not isolated individual it is the family and parents and kids are going to get the health together or probably not at all and so if an adult with children goes on a drug to lose weight it's not a skill they can leave with their children it's sort of leaving the kids behind. Its six p.m. and you take Qnexa what do you feed your kids kind of thing. So I think we can agree there is a limited role for pharmacotherapy as an alternative to surgery to fix a severe problem in an individual. But as we look at the social level we clearly need behavioral strategies and then we need to supports for those behavioral strategies in the environment the things that we can do and the places people spend your time schools, workplaces, and churches, shopping malls, and supermarkets and so forth to make eating well and being active easier for everybody for adults and children alike.

Miller: Let me grab a call here from Pamela in McKinley, Hi thank you for waiting.

Pamela (caller): Thank you, I am a victim of Fen Phen since 1996 and had two open heart surgeries with an artificial value for my fourth defibrillator and if I don't get a heart or a pump I will be dying and it's because Fen Phen was made by Wyeth who lied about the results and the FDA just slid it through and did not do the testing it needed so I am dying because Wyeth Laboratories and the FDA's urgency to get this medication out on the market and I really urge everybody to think at least twice before they try any diet medication, diet exercise, or medical help, or even the bariatric surgery are much preferable.

Miller: Pamela thank you so much for your call. Fen Phen Professor French, this is what the FDA is concerned about right as they look at these decisions about whether they will approve these drugs?

French: I think that their reluctance to jump into improving new weight loss drugs is no doubt colored by the Fen Phen disaster and I really am so sorry to hear about what happened to the caller. Fen Phen did heart valve damage to hundreds of people and it was an FDA approved drug and it was only after the fact that they realized this and then had to backtrack but in the meantime the damage was done and the trial that I mentioned with Qnexa combination was sponsored by a drug company. Many of the trials that are done are sponsored by the drug companies so no doubt they are more likely to show positive results but even those aren't long term results that they can rely on so I think that being conservative in light of what has happened terrible tragedies that can't be reversed being conservative is wise.

Miller: Professor French I appreciate you coming in today to talk about this and Dr. Katz thank you so much.

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Do diet pills help people lose weight?

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