Diet Drug May Battle Obesity, But Is It Worth The Cost?
A combination diet drug is expected to be approved by the FDA, and it's hailed as the next big thing in combating obesity, but the side-effects are serious.
Photos
There is a whiff of science fiction about it: two thirds of a population seems to be slowly, inexorably destroying itself. A substance comes along that stops the self-destructive behavior. However, the chemical can’t be given to women of reproductive age because of birth defects associated with it, so it will be kept under lock and key.
No, it’s not a screenplay or a scene from a dark Margaret Atwood novel. It’s the newest weight-loss medication, Qnexa. This drug got the green light from a Food and Drug Administration (FDA) advisory panel on Feb. 22, a crucial step toward approval of the drug, which is expected in April. Previously, In 2010, an FDA advisory panel nixed Qnexa, citing concerns about cardiovascular risks and birth defects associated with the drug.
With one-third of Americans obese and one-third overweight, the panel this time deemed that the benefits of Qnexa outweigh its risks. Obesity poses serious health risks, and the thinking behind the medication is that diet and lifestyle aren’t sufficient to address the problem in many people. The FDA is not required to take the advice of the panel in its final decision about the drug, but the agency generally abides by the recommendations of the advisory group.
Studies on Qnexa show that people who took the drug averaged a 10 percent loss in body weight over two years. But the results come with a price—escalated heart rate and greater likelihood of birth defects. Qnexa ups the risk of cleft lip and cleft palate significantly. It will not be prescribed to pregnant women, and women of childbearing age who take the drug will undergo monthly pregnancy tests. The drug manufacturer, Vivus, of Mountain View, Calif., pledged to put safeguards in place to monitor the drug’s use and to ensure that pregnant women do not take it.
These safeguards include training for health care providers who prescribe the drug and limited access to the drug through only a few select mail-order pharmacies. The promise of these safeguards factored into the panel’s decision to OK Qnexa this time. Vivus will also conduct additional clinical trials on Qnexa, but not until after it is approved.
Qnexa is a combination of phentermine, which suppresses appetite, and topiramate, which is used to treat epilepsy. Both phentermine and topiramate are available as individual drugs, but Qnexa combines them in extended-release form and at lower dosages.
When it becomes available, Qnexa will join the only other weight-loss drug on the market, Xenical, which inhibits the body from absorbing fat. The side effects of Xenical, delicately referred to as “change in bowel habits,” proved too embarrassing and troublesome for many people who tried the drug after it was approved in 1999.
Some hail the potential addition of Qnexa to the weight-loss armament as a positive development for people who struggle to lose weight with other methods. Skeptics worry about the side effects, which can also include memory loss and difficulty concentrating, and about the fact that some people quickly regain the weight they lost when they stop taking the medication.
Drugs like phentermine that suppress your appetite will spur weight loss, but cause people to lose muscle, which cuts the ability to burn calories, notes Susan Sklar, M.D., founder and medical director of the Sklar Center in Long Beach. “When you lose muscle, you lose your calorie-burning capacity.” The loss of adequate muscle to burn calories efficiently puts people on a path where they can only eat increasingly smaller amounts of food a day to try to maintain their weight, Sklar says. “They will go from 1,500 calories, to 1,200 calories, to 1,000 calories, which isn’t a lot of food. That’s why you hear people say, ‘I can’t even look at food without gaining weight.’”
She also observes that topiramate, the anticonvulsant contained in Qnexa, interferes with memory and mental function. The brand name of topiramate is Topamax. The memory loss some people experience with Topamax has led to its nickname, “Dopamax,” Sklar says.
Long Beach personal trainer Kelle Erwin says the lure of a quick fix with a weight-loss pill may be tempting, but moving the needle down on the scale has no benefit if there are other health costs. “The idea that you would take something that potentially damages your body to lose weight makes no sense to me,” she says. Erwin, who is also trained as an emergency medical technician (EMT), says she helps her clients make one change at a time in their diet and exercise patterns, so that they don’t become overwhelmed and give up. “The outcomes are slower, but they are more permanent.”
The long-term results and effects of Qnexa will not be revealed until after the drug is approved and more people have taken it. The enormous spike in Vivus stock after the FDA panel approval suggests that sales of the drug are expected to be brisk.
TELL US WHAT YOU THINK IN THE COMMENTS
Do the benefits of the diet drug outweigh its side effects?
Christi Wheeler, MS, RD
6:54 am on Monday, February 27, 2012
I think the risks of the drug far outweigh any potential benefits. I discuss this in detail here: www.foodfactorfiction.com
Sarah Church
7:55 am on Monday, February 27, 2012
Why would one risk their life to try to reduce weight when a healthier (although controversial) alternative with relatively no side effects are available with a medically supervised HCG diet. See the benefits of HCG injections here: www.slimspamedical.com
Micheal Mouse
8:03 am on Monday, February 27, 2012
Dex-A-Trim worked extremely well, with few side effects to maintain weight and after billion and billions of doses some studies showed a very weak link to a heart problem. It was immediately banned, along with Phen/fen. Now we have billions of people overweight dying from all kinds of obesity diseases because all the weight loss drugs have been banned.
Now let me see, to save 100 or less people world wide from diet pill effects, we banned them and now are killing hundreds of millions. This is a perfect example of why the government and lawyers should not be involved in health care and just the patient and doctor
Katherine
8:29 am on Monday, February 27, 2012
I have taken Topamax for seizures. I had horrible side affects that made me get off the medication immediately. Horrible memory loss and stuttering were my side affects. I myself would never again take this medication but it does not mean that everyone would have the same experience. Just be alert to any weird things that may begin to occur and inmediately tell your doctor.
Katherine
8:34 am on Monday, February 27, 2012
Michael, there are thousands and thousands of people on Topamax for seizures. If it were going to kill hundreds of millions epileptics would not be taking it.
Susan
8:49 am on Monday, February 27, 2012
Katherine- I am pretty sure he was implying that the hundreds of millions are a result of not prescribing millions weight loss drugs and letting them die from the effects of obesity.
Janet Daley
9:59 am on Monday, February 27, 2012
NO ONE NEEDS A DRUG FOR OBESITY: The food was changed in the USA, UK and Australia 30 years ago when dangerous food chemicals from the USA was allowed into European.
The food today causes stubborn insulin If you have stubborn insulin you hold fat and have a hard time losing weight.
You can eat very little and the weight still does not come off. Stubborn insulin will hold fat and diets won't work. When researchers used a specialized diabetes diet on overweight people all lost weight even those who did not have diabetes.
The diet proved food chemicals are why dieting does not work this was proven on Midland News SEE here http://www.ourmidland.com/voices/health/article_062da990-12cf-11e1-a523-0017a4aa8e72.html
Debbie Flanagan
12:52 pm on Monday, February 27, 2012
What happened to a balanced diet and exercise? Both are needed to successfully lose weight. Eat more fruits and vegetables. Stop eating fried and processed food.
Pills are the #1 cause of death in America. Statistically every 14 minutes someone dies of a prescription overdose.
Laura Lee Bloor
1:12 pm on Monday, February 27, 2012
It's a shame so many people are willing to turn to diet pills that have potentially harmful side effects all in the name of a quick fix. Qnexa isn't the first and I'm sure it certainly won't be the last as long as there is demand.
Encourage your loved ones to manage their weight the healthy, tried-and-true way: Work with a trusted doctor and/or health coach to create a plan that includes a balanced diet and exercise, as Debbie mentioned.
Jack Waggoner
1:50 pm on Monday, February 27, 2012
People (including some dietitians) just don't get it when it comes to the obese trying to lose weight, at least those who are not young.
Typically we are beyond the point where eating "like a normal person" will allow us to lose any weight at all, our metabolisms having been messed up for many years. We have yo-yo dieted so many years and have always gained the weight back, that we really have to make an extended superhuman effort in order to get any results at all. It's not like it's portrayed on the Biggest Loser - those people are carefully selected. Most of us have lots of medical issues to go along with our obesity.
So for us it is NOT a matter of just eating our food and veggies and drinking lots of water and staying on a low calorie plan. That stuff just doesn't work for long.
Unfortunately the pills aren't going to be much help either.
For some, surgery is a viable option, but it is extremely expensive, and about half of lap band patients wind up gaining most or all of the weight back within 5 years.
Very few people get this. People just say obnoxious stuff like "Eat a salad!" or "Stop laying around on the couch eating potato chips all day!" even though they know nothing of our efforts to try and lose weight.
For me, I am having success eating a very low carb ketogenic diet (<20g carbs). I've lost 67 lbs. so far, and need to lose about another 60 to get to a 25 BMI. If I continue to be successful, this is how I will eat for the rest of my life.
mfriedrich
4:37 pm on Monday, February 27, 2012
Also, some people become obese because they have serious gland disorders, pituitary and thyroid-related. This is often not considered by the critical eye. It's not their fault. Some people have tried medications for these issues, but there can be unpleasant side effects. Also, I know a lot of obese friends who cannot exercise sufficiently due to ankle, knee and back problems. It's very difficult and demoralizing. Once you become overweight, one health risk after another seems to keep piling on the other. But if you can perform regular exercise and then gradually kick it up a notch to more intense workouts, the body is an incredible machine. In time the fat really does "melt" off.
mfriedrich
4:28 pm on Monday, February 27, 2012
It's possible to increase meal frequency (eat 4 to 5 times daily) and still cut caloric intake (reduce sugars, processed foods and refined carbs), while increasing your metabolism through brief, intense exercise sets (no more than 30 minutes per day) that create an "afterburn effect", to burn away fat, and build muscle. Lifting weights and body weight exercises are proven tactics. Drinking plenty of water, going to bed early and sleeping more hours every night are also very important for healthy weight loss and metabolism. This is really the only proven method to lose weight and keep it off with minimal health side effects. Drugs will never do this, and the risks of harming vital organs like the heart, liver and kidneys are often too great to ignore.
Jack Waggoner
4:44 pm on Monday, February 27, 2012
Again, misunderstanding of the issue, of whom these drugs are intended for.
I don't know about the very obese people you deal with on a regular basis, but most of us when we get to a certain point cannot really exercise much. Or, when we do, we break down quickly. For people who need to lose 100 lbs. or more, exercise is not much of an option. Our feet can't handle it. Our knees can't handle it. Our own body weight is an obstacle. I'm not saying that we didn't get ourselves to this point, but the solution of exercise for 300+ lb non-NFL players is not very practical. Even less practical for women in this position.
Now that I am maybe 60 lbs. overweight, exercise is a possibility. But I had to lose the first 60 lbs. just to get to that point where my body can now handle it. Exercise hasn't made me lose weight, but losing weight has made it possible for me to exercise.
Jack Waggoner
4:49 pm on Monday, February 27, 2012
Just noticed that this article is listed under "Obituaries", lol. Note to Patch: We're not dead yet!
Morgan Downey
5:13 pm on Monday, February 27, 2012
Excuse me but what about the facts? Phentermine has been on the market for years and has been exonerated of any involvement in the phen-fen issue. Did the reporter comment when topiramate (Topomax) was approved for prevention of migraines, especially in women of childbearing potential? Also, the writer might be interested to know that obesity is a major cause of stillbirths and infants deaths as well as profound birth defects, such as neural tube defects. Get your facts straight.
Jack Waggoner
8:14 pm on Monday, February 27, 2012
Even so... 10% average weight loss in 2 years? Really? That's what we're going to get from this? I guess every little bit helps... but the side effects already known make the risk-benefit equation for this drug poor at best.
Ken Hnf
6:51 am on Tuesday, February 28, 2012
Whether the FDA approves this drug or not, I believe that achieving Weight Loss through Natural Diet and Exercise is still the best way to go.
http://www.dietfoodsweightloss.com
KSatmary
9:29 pm on Wednesday, February 29, 2012
Congratulation Jack for your weight loss. That's a success! I work with a health & wellness company and we teach healthy living classes. It's not a diet class. I don't even use that "d" word. It's a way of life not a temporary fix like several of you mentioned. I tried for 16 years to get rid of extra weight but never could get it down and keep it down until I made some exchanges of certain foods. Like using gluten-free foods, brown rice pasta and so on. Our foods don't have the nutrition they used to and the FDA allows so many crazy things pass that are considered food. So we need to really be careful what we eat. If you want more information contact me through my website. I'd be happy to share the Healthy Living Plan with you. http://www.karensatmary.myarbonne.com/arbonne/karensatmary.nsf
Brent Full
1:29 am on Wednesday, March 28, 2012
Very informative and helpful article indeed. Though I don't see anything wrong with using safe drugs in battling obesity, I firmly believe that exercise and proper diet is the key to health. I'm a bit concern right now with my son having weight issues right now, I do not force him to take diet instead I exercise with him as much as possible during weekends. It's pretty bothering that obesity is rapidly growing as an epedemic here in the US. I read in an article http://reallycheaphealthinsurance.com/the-monster-episode-2-dr-aculas-obesity-woes/ that obesity can even lead to Cancer and other Psychiatric Disorders.