Hopefully, this drug will fail before taking off and making pharmaceutical companies BILLIONS of dollars, but just in case, I am writing this as a warning to those who are considering the drug for personal use. And if you know better, at least illustrate how important it is to research medications, supplements and herbs before you trust regulatory agencies that it is safe.
Contrary to statements made by Vivus, the manufacturer of QNEXA, about their concern on rising obesity rates, their only concern is the bottom line. The more they can cloud the truth and make this drug appear safe, the more money they get in the end. But if you succumb to their deception, the things you are likely to lose is your money and possibly your health, but not excess weight.
I base my position on this from a few different perspectives. First of all, my education. As much as one would like to believe that taking a pill will cure obesity, my two degrees in Nutrition have taught this much - obesity is multi-faceted problem, no one solution will fix it for everyone. Superseding the body’s natural regulation of hunger (which is the mechanism for QNEXA) will only go so far since there are numerous reasons of why we eat what we do, that go beyond these physiologic cues. Secondly, my experience. I work with patients who have epilepsy and many are on topiramate, one of the drugs used to make QNEXA. I’ve seen the side effects first hand and while it is successful at decreasing appetite and inducing weight loss it comes at a cost. I’ve also worked with adults and children to promote weight management. Everyone is different and success at achieving a healthy weight needs to be addressed as such. Finally, but most important, research. After reviewing the results of the trials and researching the side effects of the drugs used, I’ve concluded that the risks far outweigh the benefits.
QNEXA is described my Vivus as a drug intended to be used by overweight or obese candidates, based on a BMI >27 kg/m2 AND also must have co-morbidities associated with obesity such as high blood pressure, type-2 diabetes or abnormal cholesterol levels. While many Americans fall into the category of BMI >27, not all of them have these co-morbidities. The reverse is also true; many people have these conditions but are at a normal weight. According to a recent study published in the International Journal of Obesity, researchers found that 29% of people classified in the “normal” BMI range (<25), have heart disease risk factors similar to people who are obese. So, to say that QNEXA will make a significant difference in obesity risk factors is an overstatement, as its target will be only a portion of the obese population.
The pill itself is a combination of topiramate and phentermine, which are both FDA-approved medications. Topiramate is used for treatment of migraines and seizures and phentermine is a well-known drug for weight loss. The FDA originally denied approval of the QNEXA in 2010, stating that the risks associated with the drug were too high and long term effects were unknown, given that the trial was only 1 year. QNEXA extended the trial and gave the FDA advisory panel 2 years worth of data, which they have now surprisingly endorsed in a 20-2 vote. While the FDA does not have to take the advisory panel's recommendation, it is likely they will. So what changed the panel's mind?
The results of the Vivus trials averaged about a 10% weight loss in a year. For example, a 200 lb individual lost 20 lbs. Research shows that modest weight loss such as 5-10% of your body weight can reduce your risk of chronic disease. What is interesting is the sharpest drop in weight is seen in the first 4 to 8 weeks. The first 4 weeks subjects were being titrated onto the full dose, so they weren't actually receiving the full dose until week 4. Obviously, the subjects were geared up for the weight loss trial and were changing their diets and activity levels which resulted in weight loss. Even the placebo group experienced the same trend of weight loss initially, albeit not as great as the QNEXA group. The graphs of this can be seen on page 67 of the initial report from 2010 to the FDA (link is below). The weight loss continues to trend but begins to plateau after 6 months. Many people who change their lifestyle with the help of dietitians, personal trainers and organized programs such as Weight Watchers experience far greater results in much less time. Even if the weight loss was far greater, that completely avoids the issue of maintaining the weight loss after you stop taking the pill. As far as I could find, no trials have been done to see how long people were able to maintain the weight loss after they stopped taking QNEXA. The positive effects like decreased sleep apnea and lowered blood pressure can be explained by losing weight alone, the pill itself does not reverse those conditions. A magic bullet, QNEXA is not.
As for their risks, the manufacturers state side effects of faster heart rate and incidence of cleft lip or palate in children for women who become pregnant during the trial. They argue, that with education to health care providers to encourage birth control use and monthly pregnancy tests, this is controllable. Sounds reasonable. Except for the part where one of the many side effects of topiramate is that it makes birth control pills LESS effective! I’m curious to know how they justified that to the FDA.
Since we are talking about side-effects of topiramate and phentermine, let’s list them all out. Topiramate can cause decreased appetite and weight loss, but for some also increased appetite and weight gain! It can also lead to nausea, diarrhea, constipation, changes in how food tastes, indigestion, dry mouth, gingivitis, abdominal pain, decreased liver and kidney function, tremors, confusion, mood changes, nervousness, depression, back pain, apathy, fatigue, weakness, muscle pain, edema and menstrual changes. Phentermine can cause nausea, vomiting, diarrhea, constipation, can increase blood pressure and heart rate, tremors, dizziness, headache and insomnia. Phentermine can also be habit-forming and it is recommended to avoid alcohol and caffeine. It is also noted to be used with caution in those with diabetes as it can alter diabetes medications.
I lost my appetite just reading those side-effects.
To sum up, QNEXA claims to reduce risks associated with obesity, yet the two drugs used to make QNEXA are cautioned against being used in that very population! It is targeted to treat people with conditions that are contraindicated (diabetes and high blood pressure). The fact that this was completely disregarded by the FDA is frankly, frightening. Yes, obesity has its risks and treatment is important, but the QNEXA drug has the same risks, if not to an even higher degree. If this were the only option to help people improve their health, then I would understand accepting the risks, but there are other tried and true methods and QNEXA is not one of them. This is plain and simple all about money. And no amount of money is worth your life.
FDA Bless Weight-Loss Pill http://online.wsj.com/article/SB10001424052970203960804577239642544675320.html
Zaneta M. Pronsky, MS, RD, LDN, FADA . Food Medication Interactions. 13th Edition, 2004.
Qnexa Advisory Committee Briefing Document. July 2010.
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm218821.pdf
Body mass index classification misses subjects with increased cardiometabolic risk factors related to elevated adiposity. International Journal of Obesity (2012) 36, 286–294; doi:10.1038/ijo.2011.100; published online 17 May 2011 http://www.nature.com/ijo/journal/v36/n2/abs/ijo2011100a.html http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm218821.pdf
Christi, you have written a very science-based and rational discussion of this weight loss pill. Your facts are credible and I hope anyone considering taking this drug when it becomes available will seriously consider seeing a registered Dietitian and learning lifelong diet and lifestyle changes instead of seeking a magic bullet that does not exist. Christine Gerbstadt, MD, RD
ReplyDeleteThanks Christine! I hope so too!
DeleteFirst thing, I agree with you that the drug is not a good option, and potentially a very bad one. The average weight loss on this drug is 10% of body weight over 2 years. This is nowhere near enough potential benefit to offset its significant risks.
ReplyDeleteThat being said, I think there is a need for some option for the highly obese that is less expensive and less invasive than bariatric surgery. And I'm sorry, but the diets I have received from dietitians in the past were nearly impossible for me to stick with, and not really that effective even during the time I was able to stick with them. Someone very obese needs to lose weight pretty quickly. We can't fiddle around with a pound or two a month when we have 120 pounds to lose. And, frankly, when we're that fat, and have other health problems as well, it's almost impossible to get much exercise... our feet and knees break down in a hurry, and a lot of us have out of control diabetes, high blood pressure, low HDL, high total cholesterol and triglycerides, and are generally in horrible shape.
At the beginning of September, I was in such horrible shape that I couldn't walk a block. My diabetes was out of control despite 100 units of Lantus and Novolog per day and 8 mg Avandia and 2000 mg metformin. My a1c was in the teens. I weighed 310 lbs. at 6'0", which I estimate to be 126 lbs overweight, and that's using 25 BMI as a standard... that may very well be an underestimate.
I am having, thus far, good success with a ketogenic diet of my own design that I am sure you would never recommend. I'm 67 lbs. down so far, which I estimate is still 59 lbs. overweight. My HDL is up, LDL down, triglycerides way down, blood pressure down. Most importantly, a1c is under 7 (and falling) for the first time since the 90s. And I'm no longer taking either form of insulin, nor Avandia. Just the metformin.
I would like to address something I read in one of your blog posts about diets with less than 35% carbs causing a lack of energy. I'm eating way, way less than that for nearly 6 months, without exception. I have more energy than I have had in years. I am still not in great shape, but I can walk a couple of miles now, and generally feel a lot better every day. I have not lost weight by exercising, for the most part, but I can exercise now - because I have lost weight.
Whatever you may think of my diet (which is clearly not for everyone), it seems to be working just fine for me. The weight loss is slowing down some, but I think that is probably to be expected after 67 lbs.
I will close by saying that I believe I probably will have to eat pretty much this way for the rest of my life. As much as I have given up a lot of foods that I have always loved, I am grateful that there are still so many foods that I do eat that are delicious, and would be considered decadent on most conventional diets.
67 pounds! That is great! It is evident that you have found a method for weight loss that you can stick with, which is an important factor to consider when looking for an option to improve your health. If you can't maintain the weight loss than what is the point in busting your butt with diet restrictions and exercise routines if you can't keep it off, right? I also want to APPLAUD you for using lab markers (cholesterol, blood pressure and A1c) as an additional measure of success beyond the number on the scale. After all, you can be thin and be unhealthy!
DeleteI am sorry that you have had unsuccessful results with dietitians in the past. Unfortunately, like any speciality or field, there are different opinions and experiences that can cloud judgements and impact people negatively. While there are many nutrition and weight loss tips that can help out the majority, there is not any one thing that will help everyone. There are simply too many factors to consider, many of which you personally have experienced such as difficulty exercising and chronic diseases that impact weight.
As for the ketogenic diet, I actually specialize in this area. I've worked with patients using this as weight loss in the past, but most recently use it clinically to treat children with epilepsy. It is very effective and also very strict. The fact that you can stick with it and are seeing such fabulous results is a testament to your determination and perseverance! You should definitely be proud. The basics of this, do fall under the recommendation for carbohydrates (40% of the diet), however the exception is that the body is in ketosis, or using fat as primary fuel instead of glucose coming from carbohydrates. It can take a couple days for the haze to clear, but once in ketosis usually those symptoms reverse. What I was referring to in my post was a general recommendation, especially for those exercising regularly that higher amounts of carbohydrates are needed. Typically, people cannot maintain low amounts of carbohydrates for a significant amount of time so they are fluctuating in and out of a steady state of ketosis and fatigue can be a problem (from my experience). I have polycystic ovarian syndrome, which causes insulin resistance. I understand how difficult it can be to lose weight. I use a modification of the ketogenic diet myself, a blend between the Zone and a low-glycemic diet. On days when I work out, I eat more carbohydrates, but make sure I choose low-glycemic options and pair with protein. It has been the only thing that has worked well for me.
I wouldn't recommend the ketogenic diet to everyone and definitely not without caution. That said, you are obviously healthier, cholesterol, blood pressure and glucose control has improved, you have more energy and can now exercise (which brings a host of benefits to the table). As long as you are regularly being followed by a health professional to watch kidney and liver function, blood sugar levels and adjusting medication as needed I would conclude that you should continue with this diet plan. As a disclaimer, I say that just based on limited info you've provided.
And you are right, you have to make permanent lifestyle changes. As for the weight loss slowing down, sometimes you have to actually increase your calorie level to rev up the metabolism burn. In addition to continue exercising and increasing as you are able.
Keep up the great work! And thank you for reading my blog and taking the time to share your weight loss journey with me! I wish you all the best!
~Christi
Thanks, Christi.
ReplyDeleteMy doctor feels pretty much the same way, advised me to keep doing what I'm doing. Kidney/liver tests were normal a few months ago. Not sure when she plans on doing them again. That might depend on what the insurance company allows.
I think it very likely that I have been in ketosis since early September 2011. I've never actually verified this with testing nor have I had "symptoms" since a few weeks after I started. When I have gotten a little stuck in the past, I've increased the carbs. Which pretty much means, at this level, that I might have had an extra handful of broccoli or some Brussels sprouts.
Mostly I work off the meter. I can have almost unbelievably tight control using the meter to instruct me as to what is working.