Monday, February 27, 2012

Weight Loss, At Your Own Peril?

 Qnexa has been approved by the FDA to be the first anti-obesity drug in the U.S.

They say that in treating alcoholism and drug addiction, that the chemical dependency is merely a symptom of a larger problem - simply not drinking will not be enough. The same could be said for the treatment of eating disorders, as we see with anorexia and bulimia.


If you are in the know regarding eating disorders, then you know that the consequences of not maintaining a healthy body weight can be severe. Anorexia Nervosa is probably the best-known eating disorder to the public. According to the University of Maryland Medical Center, Anorexia Nervosa is defined as "a psychiatric disorder characterized by abnormal eating behavior, severe self-induced weight loss, and psychiatric comorbidities." But, they are also quick to point out that the behaviors of controlling your intake of calories is not about food at all. It is about emotional control. "Anorexia is an emotional disorder that focuses on food, but it is actually an attempt to deal with perfectionism and a desire to gain control by strictly regulating food and weight. People with anorexia often feel that their self esteem is tied to how thin they are" (www.umm.edu). This is important to know, because unless we understand the underlying reasons for the eating disorder, then we would continue to chase the symptoms and never treat the disease. 

Anorexia Nervosa's counterpart, Bulimia Nervosa is equally devastating for the sufferer. According to the Mayo Clinic, Bulimia Nervosa has a differing set of symptoms, but is often times a misguided and hazardous attempt to control one's body image. "If you have bulimia nervosa, you are probably preoccupied with your weight and body shape, and may judge yourself severely and harshly for your self-perceived flaws" (www.mayo.com). Once again, it is not so much about the food as it is is the need to control your body image. "Because it's related to self-image — and not just about food — bulimia nervosa can be difficult to overcome. But effective bulimia nervosa treatment can help you feel better about yourself, adopt healthier eating patterns and reverse serious complications" (www.mayo.com).
But, what if your problem wasn't starving yourself into submission to a body image, but rather, an inability to control the amount of food that you take in - at any cost.
AND, what if there were serious physical side effects to having an eating disorder? There are...It is not difficult to imagine the human body like you would an engine. We are powered (fueled) by food after all, and if you don't give your body proper fuel at appropriate intervals, then you cannot imagine your body reacting very well. Imagine if you will, what would happen if you had a serious eating disorder, such as anorexia or bulimia. In the case of anorexia, you are forcing your body to run on very little fuel at all, which causes a caustic breakdown in your internal systems. Likewise, with bulimia, you are over-filling your system with food and then to offset the consumption, you are forcefully expelling the fuel by vomiting or laxatives or over-exercising to reduce your caloric intake.

The physical repercussions of this extreme behavior is devastating to that persons body. Even if they are capable of fully recovering from the eating disorder, which is not likely, they are still likely to face a lifetime of serious health problems, if they do not expire completely in the course. For example, someone with advanced anorexia could very likely experience any of the following health problems:
  • Abnormally slow heart rate and low blood pressure, which mean that the heart muscle
    is changing. The risk for heart failure rises as heart rate and blood pressure levels sink
    lower and lower.
  •  Reduction of bone density (osteoporosis), which results in dry, brittle bones. 
  • Muscle loss and weakness.
  •  Severe dehydration, which can result in kidney failure. 
  • Fainting, fatigue, and overall weakness. 
  • Dry hair and skin, hair loss is common. 
  • Growth of a downy layer of hair called lanugo all over the body, including the face, in
    an effort to keep the body warm. (www.nationaleatingdisorders.org).

Similarly, bulimia carries its own physical consequences to the body, from extreme neglect:
  • Electrolyte imbalances that can lead to irregular heartbeats and possibly heart failure
    and death. Electrolyte imbalance is caused by dehydration and loss of potassium and
    sodium from the body as a result of purging behaviors.
  • Inflammation and possible rupture of the esophagus from frequent vomiting.
  • Tooth decay and staining from stomach acids released during frequent vomiting.
  • Chronic irregular bowel movements and constipation as a result of laxative abuse.
  • Gastric rupture is an uncommon but possible side effect of binge eating.(www.nationaleatingdisorders.org)
Believe it or not, I am not all that interested in discussing anorexia (which affects between 0.5–1% of American women) and bulimia (which affects affects 1-2% of adolescent and young adult women) in this blog. What I really want to talk about is a new anti-obesity drug which has very recently been approved by the FDA, Qnexa.

Obesity is an area of eating disorders which is gaining much more attention now, then it has in the past, and for good reason. According to CDC data "about one-third of U.S. adults (33.8%) are obese" (http://www.cdc.gov/obesity/data/adult.html). In addition, the CDC reports that the obesity problem is getting increasingly worse over time, not better.



With such an emphasis on obesity - particularly childhood obesity and obesity in minority populations, there can be little doubt that we must do something! And something is being done, by way of Qnexa, the first anti-obesity medication to hit the market in a very long time. The only problem is that it is causing quite a stir in the medical profession...

In case you have not been reading the major newspapers, especially the "Health" section, as I do online, then you might not have heard about Qnexa.
Qnexa is the brand name for (phentermine and topiramate), two powerful pharmaceutical medications. According to Drugs.com, phentermine is a "stimulant that is similar to an amphetamine. Phentermine is an appetite suppressant that affects the central nervous system." Also, according to that same web site, "Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials." According to the clinical trials associated with Phentermine, there was weight loss associated with the drug, but only "a fraction of a pound a week." Drugs.com also rightly points out that "The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited." This is important to note, considering that the trials were not terribly long, and their proven effectiveness was a fraction of a pound a week. You do not need to perform clinical trials to see that you could probably achieve the same outcomes through light aerobic exercise, three times a week! 

Furthermore, there are side effects to taking Phentermine:  Bad taste in mouth; changes in sex drive; constipation; diarrhea; difficulty sleeping; dizziness; dry mouth; exaggerated sense of well being; headache; impotence; nervousness; over-stimulation; restlessness; sleeplessness; upset stomach. That's not too bad, I guess, but you don't get any of these side effects from walking or light aerobic exercise either.

The second component of Qnexa is a bit more tricky and may be the reason that Qnexa was denied by the FDA its first time around, in 2010. Topiramate is an anti-seizure drug (typically) prescribed to control seizures, treat Lennox-Gastaut syndrome and treat migraine headaches. (http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000998). So, why is an anti-seizure medication being introduced with an amphetamine to control appetite? I do not know. I am not a pharmacologist, so I cannot say what the benefits of the drug would be in suppressing appetite. What I can say is this - Topiramate can be quite hazardous to your health. 

When first investigating this new drug, I was primarily interested in the media buzz associated with the FDA approval. As I mentioned before, the FDA rejected Qnexa for approval due to serious side effects, such as heart disease and birth defects. Again, the side effects were attributed to Qnexa as a complete drug product, but I am suggesting that the culprit was Topiramate. This is a list of side effects for Topiramate, given by the NIH: numbness, burning, or tingling in the hands or feet, slowed reactions, difficulty concentrating, speech problems, especially difficulty thinking of specific words, memory problems, lack of coordination, confusion, nervousness, aggressive behavior, irritability, mood swings, depression, headache, drowsiness, weakness, excessive movement, uncontrollable shaking of a part of the body, uncontrollable eye movements, extreme thirst, weight loss, constipation, diarrhea, gas, heartburn, change in ability to taste food, swelling of the tongue, overgrowth of the gums, dry mouth, increased saliva, trouble swallowing, nosebleed, teary or dry eyes, back, muscle, or bone pain, missed menstrual periods, excessive menstrual bleeding, skin problems or changes in skin color, dandruff, hair loss, growth of hair in unusual places, ringing in the ears, difficulty falling or staying asleep, swelling of the hands, arms, feet, ankles, or lower legs, difficulty urinating or pain when urinating. This list of side effects would be comical if they were not serious. Notice that "weight loss" is a side effect of Topiramate. That would explain its inclusion as an anti-obesity drug. 

I innocently mentioned to a friend that I had heard that Qnexa was being approved by the FDA. My friend, whom I knew had a family history of migraines was outraged at the prospect of this drug being prescribed for any purpose other than its originally-intended purpose as an anti-seizure medication. She had been prescribed Topiramate for migraine headaches and experienced many of the side effects listed above. According to my friend, her time on the drug was nothing short of hellish.

According to my friend, she began experiencing side-effects two days after starting using the drug as prescribed. She described experiencing "chronic headaches" until the time that she stopped taking the medication. This is somewhat ironic considering that the family member was prescribed Topirmate as an anti-migraine medication. She also described the combination of side effects listed above, such as "slowed reactions", "speech problems" and "confusion." Listed in this way, they sound mild and tolerable if one really needs the medication. In my friends experience, these side effects were not mild in the least:

"Then it started knocking me out as soon as I'd take it. I don't mean grogginess, I mean I was GONE. Then as I upped the dose, instead of Wong knocked out, it wouldn't let me sleep. At. All. It made me extremely cold all the time. I had swelling in my hands and legs, my hair stared falling out and generally thinning, I was grasping for words CONSTANTLY. I could see it in my head no could see the milk carton in the fridge of the home of the people for whom I used to babysit, I could hear the baby crying, could see myself preparing a bottle with that milk an yet I couldn't get the word out of my mouth. Then it started happening all the time. I would be driving and all of the sudden not know where I was going. I'd have to pull over ad evaluate what time it was, determine what road I was on and then try to figure out of I was going home, to work, to pick up [my son], etc. there's a 4 month period from which I remember absolutely nothing"
Also somewhat ironic, while my friend does not have a weight issue, she gained "20 pounds in 2 weeks." That seems dramatic, especially for an ingredient in an anti-obesity medication. Again, I am not a physician or a pharmacologist. There could be a very good reason for prescribing Qnexa for anti-obesity medication, but I am just not buying it personally.

One thing that I know for certain is that, as a nation, we are addicted to two things: taking medicine and feeling good. And the pharmaceutical industry is aware of our propensity for wanting to take the path of least resistance when it comes to our overall health. Vivus, the company producing Qnexa states at the top of their page for Qnexa that "By 2030, if trends in the escalating rates of obesity continue, health care costs attributable to obesity may reach $956 billion, accounting for up to 18% of total health care costs, or $1 in every $6 spent on health care." I do not doubt the validity of this statement, but at the same time, Vivus stands to make billions of dollars in profits on the marketing of their drug to every doctor, clinic, hospital and medical facility who is treating the morbidly obese (approximately 3% of the U.S. population or 6.8 million people), according to the USAToday.And according to Forbes, Vivus will stand to be the ultimate winners in this, whether the drugs performs as expected or not. "Given past sales figures for diet drugs, Vivus can expect to make a boatload of cash on Qnexa and shareholders will smile all the way to the bank" (forbes.com). 

Another thing that I know for sure is that as a country, we have developed a very unhealthy relationship to our food. I have written a couple of blogs about how the population of African-Amerians is disproportionately slanted toward obesity, as is 1 in 3 children born after 2000. Unless we stop the trends that we have developed concerning food and nutrition, I am fearful that we will lose a whole generation of young people, particularly young women to either Anorexia Nervosa and Bulimia Nervosa at one of the spectrum and morbid obesity at the other. There is no pill that the FDA can approve which will change that.

2 comments:

  1. I notice two things off the bat - 1. It is a drug that effects the central nervous system 2. It can cause increase feelings of well being.

    I don't know the first thing about meds, but it sounds to me like it gets you high to some degree. If it does that, then it in turn changes the firing patterns of your neurons. Consumers need to start asking questions, such as 'how' and 'will I become addicted?'

    ReplyDelete
  2. Thanks you. Very good post.Unless they can offer a really compelling reason for users to come back, it will be the next Bebo, MySpace.

    weightloss medication

    ReplyDelete

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