Research Position Paper – Jon Otero

Qnexa and Combatting Obesity

In the modern American society, the prevalence of obesity is rising at a startling rate. At some point, these unfortunate men and women reach a threshold at which diet and exercise may become too difficult and even dangerous. For this reason, pharmaceutical companies have been researching chemicals that can facilitate the transition to optimal weight levels. However, in order to ensure the safety of Americans, the FDA rarely approves these drugs because of the risky negative side effects, specifically heart and artery damage. The most recent of these drugs trying for FDA approval is Vivus’s Qnexa; a combination of the FDA approved drugs, Phentermine and Topiramate. For those unfortunate and sick people plagued by obesity, Qnexa could be the deciding factor between life and death. The difficulty in Qnexa’s approval stems from the misinformation published about the drug and obesity, which must be refuted effectively in order to convince the public and the FDA just how profound the effect of this decision will be. Since obesity’s cause is from complex organic chemical imbalances within the body, Qnexa should be approved to help obese lose weight and prevent deathly illnesses linked to the medical condition.

Qnexa is not the heart hazardous drug the FDA has previously suspected it of being. Phentermine is unlike most previously banned drugs called amphetamines that increased chance of heart attack, caused dangerous increases in blood pressure, and eventually yielded heart valve damage. One of the reasons why Qnexa was originally denied approval by the FDA may be its indirect affiliation with a banned drug, Fen-Phen. Interestingly enough, the reason why Fen-Phen was banned is because of Fenfluramine, which was banned for causing 30% testers to develop very abnormal cardiograms (FDA). Phentermine has not yielded kind of hazardous effects to the heart and is safe to use, and its safety is probably why the FDA approves it. However, the other component of Qnexa, Topiramate, has been found to cause negative side effects for pregnant women. Qnexa shouldn’t be taken by women who are pregnant due to Topiramate’s effect of doubling the likelihood of having a child born with a cleft palate from .7% to 1.4% (Roth). In that circumstance, an operation would have to be performed to correct the abnormality. This effect on pregnant women is the only risk a person would have to weigh before taking Qnexa and this applies to a very small fraction of obese people. Based on the results of its test trials, the drug is very safe and effective.

Being obese is like having a ticking time bomb to one’s chest since it poses so many risks in such a broad spectrum of bodily functions. Within the cardiovascular system, obesity causes plaque to build up in the arteries. This plague leaves an obese person susceptible to high blood pressure, coronary heart disease, and even stroke. For a woman in her childbearing years, an obese woman faces a plethora of long-term complications for both herself and the child. One of the largest issues occurs due to the heightened blood pressure of the mother, which results low birth weights from the restricted blood flow to the fetus. Oppositely, if Gestational Diabetes is developed, the child gains too much weight in development and is born with a predisposition to childhood obesity. Another issue the mother faces is the difficulty to gather fine details on the development of the child during ultrasounds. Since the high amount of fat obstructs the waves, the view of the child is often blurry and chances of picking up problems in fetal development are decreased. Due to the risk of having a child born with a cleft palate, Vivus has excluded pregnant women in its filing for FDA approval. Women in their child bearing years should keep in mind that remaining obese can endanger the life of their child if they should ever conceive and that taking Qnexa would unlikely affect a future child.  Losing weight should be priority for women planning on having a child in the future and pregnancy should be avoided before reaching a healthy BMI.

The only possible way Qnexa could pose a danger to one’s health would be in the case of misuse. As with all drugs, it’s a chemical that should be taken responsibly. Obesity is much more detrimental to the lives of people it has taken hold of than just the heart and pregnancy risks. With enough time, obesity can indirectly cause a variety of issues to arise. Type 2 diabetes is another dangerous risk of having so much excessive weight. In this case, the individual’s body has become unable to produce insulin at sufficient levels or at all. Having diabetes only increases the risk of heart disease and stroke risk, but also predisposes individuals to kidney disease and blindness (National Heart Lung and Blood Institute). The increase weight also has a great toll on the support system for the body, the skeleton, since the bones experiences much more wear and tear. Finally, studies conducted by the National Caner Institute have shown that obesity increases the risk of cancers of the esophagus, pancreas, colon, rectum, breast, endometrium, kidneys, thyroid, and gallbladder (National Cancer Institute).

Despite all the evidence pointing to the safety and benefits of Qnexa, opponents of it still refuse to release “unnecessary” dangers to the public. Even as concern is rising over the staggering obesity trend, many people are under the impression that the epidemic is due to poor dietary choices. News of a drug that could fight obesity, currently under trial by the FDA, doesn’t raise concern because they feel like the choosing foods wisely would be the ultimate solution. With the information they’ve been given, that would logically be correct. However, even though obesity is not actually classified as a disease, it is far from merely being a lifestyle choice and has been proven to be full of dangers. Thanks to public media, many Americans are under the assumption that the obese third of the population have fallen into the depths of their own gluttony. The blame has been put on the accessibility of food and the resulting lack of exercise in this industrial luxurious economy. This correlation has become the icon of the dilemma in many Americans’ eyes because it provides a sense of assurance that obesity can be so simply explained. In order for any progress to truly be made in this battle against American obesity, an understanding must be made that obesity is the result of many different factors. Rather than just being the immediate consequences of lifestyle choices, a person’s body shape and weight are the complex balances of chemical regulations in the body responding to food intake.

Obesity can start before birth. During pregnancy, an obese mother has a high risk of developing gestational diabetes. A child born to a mother with gestational diabetes will have a high birth weight and increased susceptibility to childhood and adult obesity. The unhealthy pregnancy term deprives the fetus of proper metabolic development and its body will have a tendency to retain weight in order to maintain a flawed balance of regulatory chemicals like enzymes. Throughout its lifespan, that child will go on to consume foods and its body will process that energy and conservatively utilize it. A mother’s health prior to the birth of her child plays a key role in its body’s weight permanently.

Humanity has adapted many species and individual survival methods that involve storing fat. Throughout the history of mankind, different populations have survived in the hottest of deserts to the sheerest chills of the subarctic climate. To do so, they had to develop adaptations on a cultural and genetic level. Women have particularly developed skills, genetically, to ensure the survivability of the species. Female buffering is the reason why in a similar environment, a sister of the same age as her brother will tend to be taller, have more fat, and consequently weigh more. This essential ability of the female anatomy is regarded as a nuisance today since it makes it so difficult for women to lose weight. In the event that a woman tries to diet and exercise her way to lose weight, she may encounter extreme difficulty due to the effects of female buffering, which works on the very same hormones that makes a human develop into a female. Estrogen has been proven to have fat-retaining properties, causing it to be stored generally around the hips and thigh area to form a pear shaped body. However, the amount of fat stored and locations of its deposits are genetically inherited.

Heredity is a more direct genetic role in the shaping of a person’s body. While it is true that family values and diets are often a heavy influence on those of a child, parental genetic makeup also plays a crucial role. “Twin and population studies have revealed that both body mass index (BMI) and waist/hip ratio (WHR) are heritable traits, with genetics accounting for 25–70% of the observed variability.” (Gesta) Different genes determine how a person will process energy. For this reason, two people following the same diet and exercise routine may find contrasting results in their bodily reactions. This is because our genes instruct the body how it should spend energy, where it should store energy, how many fat cells to store, and even how quickly the body should resort to using stored energy. Obesity can be passed down via genetic inheritance just like the many diseases that exist today like Alzheimer’s disease and Huntington’s disease. The genes causing someone to have more weight than what is deemed average may code for inadequate or insufficient regulation of bodily chemicals designed to maintain balance. A great example of such imbalance is type 1 diabetes, an inherited disease that can cause people to lose weight because their bodies cannot breakdown glucose. However, genetics play much more of a role in the shaping of the body, even without causing a disease. The complexities of the effects genes have on our weight are still elusive to scientists today, but progress is being made toward associating certain gene types with the production of adipose tissue.

The body’s metabolism, heavily affected by the production of thyroid hormones, plays a crucial role in a person’s weight, fat, and energy. The importance of the thyroid gland and hormone become very apparent when people suffer from hypothyroidism, the term used to describe the condition when the body manufactures inadequate amounts of thyroid hormones. “Symptoms of hypothyroidism include lack of energy, depression, constipation, weight gain, hair loss, dry skin, dry coarse hair…” (PubMed Health) A low metabolism can account for a person feeling too tired to carry out normal tasks because food energy is not being burned at an efficient rate. Studies have shown that variations in the productivity of the thyroid gland are linked with the occurrence of obesity. A study conducted by the Endocrine Society concluded, “Thyroid function (also within the normal range) could be one of several factors acting in concert to determine body weight in a population. Even slightly elevated serum TSH levels are associated with an increase in the occurrence of obesity.” (Knudsen)

As counterintuitive as it may seem, malnutrition is a huge factor of obesity in the United States. Typical Americans associate the availability of cheaply priced foods as the result of obesity simply because there is so much of it. However, there are a ton of complex issues at hand lurking behind this rouse. Not all Americans can afford the luxury of nutrient foods that have been deemed healthy and wholesome. Instead, due to the economical constraints placed upon them, they resort to the food that is available. “A newly appreciated paradox has been described that links poverty, food insecurity, and malnutrition to obesity, or the state of overnutrition.” (Tanumihardjo) Malnutrition caused by “overnutrition” occurs because the readily available food for Americans is very high in calories, yet deficient in essential body nutrients. Furthermore, the deprivation of essential diverse nutrients causes people to be hungry more often. This is the human body’s chemical reaction to being starved, although the outward appearance may falsely show that the person could benefit from eating less or working out. A long period of this deprived state could render a person unable to exercise due to a feeling of lethargy. This too is one of the body’s defense mechanisms against starvation so that it may retain energy for survival purposes. Since the body retains energy by creating fat cells, a person will gain weight from this condition. The inability to afford wholesome foods results in hunger and malnutrition. As a result, it comes of no surprise that a study of the American Dietetic Association has concluded that, “households characterized as food insecure also have the highest body mass index and prevalence of obesity.” (Tanumihardjo) This survival reaction has been imprinted in our genetic blueprint passed down over innumerous generations through the slow powerful process of evolution.

The excuse that drugs shouldn’t be passed for a non-disease is not fair to those suffering from deathly medical conditions. Firstly, the FDA has passed a plethora of drugs targeting many “non-diseases” classified as medical conditions or disorders. Eczema, a skin disorder, is just one of many conditions for which the FDA has already approved drugs to treat. The fact that obesity is a medical condition according to the CDC should not be taken as an excuse to disregard its prevalence and dangers. Furthermore, its linkage to many diseases and other irreversible conditions should be of paramount concern, as these comorbid complications have no cure. Such diseases like coronary heart disease, type 2 diabetes, high blood pressure, stroke, and osteoarthritis are just some of many complications that a person becomes susceptible to as they continue their lives as obese.

Opponents argue that most people don’t even die from obesity. While technically true, the same style of thinking would apply to every disease, condition, and injury including heart attack, cancer, gun shot wounds, etc. These are precipitating causes of death, while the immediate cause is always organ failure. While not classified as a disease, obesity is a serious medical condition linked to a plethora of complications, diseases, and other conditions to cause it to be a big concern for the Center of Disease Control (CDC). Its Division of Nutrition, Physical Activity, and Obesity (DNPAO) is attempting to address the issue by combating some of the factors that contribute to nation’s current epidemic. If the situation were left alone, many Americans would die. “Individuals who are obese have a significantly increased risk of death from all causes, compared with healthy weight individuals.” (WIN) Even though obesity cannot technically be deemed as the cause of death, it indirectly takes the lives of the people it has affected in one form or another.

Like any problem with multiple causes, no one solution will be enough for the battle against obesity. “Pharmacotherapy and bariatric surgery have better outcomes when augmented by lifestyle treatment compared with either approach alone.” (Burke) Addressing the contributing causes to obesity and acknowledging its complexity may hold to be the best hope America has at effectively combating the onslaught.

The reason why obesity has become the condition it is in the United States is due to many economical, environmental, and genetic factors. Without proper education on the various stressors that are affecting the obese, progress toward the solution will not be any easier. Obesity and the spectrum of BMI that we have in America are the results of many contributing factors that point out lifestyle choices cannot be the direct cause of such an onslaught. Indeed, many people are born predisposed to becoming obese in their lifetime. Although it may be uncomforting, we may never find out all of the chemical intricacies that play a role in the body’s production of excess fat. Knowing that obesity is not a choice, but a disease, safe measures should be adopted to help the situation, like the adoption of DNPAO programs and approval of safe drugs like Qnexa. These measures can help lower the mortality rates associated with obesity.

Works Cited

Burke, Lora E., and Jing Wang. “Treatment Strategies for Overweight and Obesity.“ Journal of Nursing Scholarship 43.4 (2011): 368-75. Web.

Gesta, Stephane, Matthias Blüher, Yuji Yamamoto, Andrew W. Norris, Janin Berndt, Susan Kralisch, Jeremie Boucher, Choy Lewis, and C. R. Kahn. “Evidence for a Role of Developmental Genes in the Origin of Obesity and Body Fat Distribution.“ Proceedings of the National Academy of Sciences. 9 Mar. 2006. Web. 12 Apr. 2012.

Knudsen, Nils, Peter Laurberg, Lone B. Rasmussen, Inge Inge Bülow, Hans Perrild, Lars Ovesen, and Torben Jørgensen. “Small Differences in Thyroid Function May Be Important for Body Mass Index and the Occurrence of Obesity in the Population.“ The Journal of Clinical Endocrinology & Metabolism. July 2005. Web. 12 Apr. 2012.

Roth, Jeffrey J. “FDA Warns Against Use of Topamax by Women of Childbearing Age.Las Vegas Plastic Surgery. Web. 08 Mar. 2012.

Tanumihardjo, Sherry A., Cheryl Anderson, Martha Kaufer-Horwitz, Lars Bode, Nancy J. Emenaker, Andrea M. Haqq, Jessie A. Satia, Heidi J. Silver, and Diane D. Stadler. “Poverty, Obesity, and Malnutrition: An International Perspective Recognizing the Paradox“ Journal of the American Dietetic Association. Web.

Thyroid.“ PubMed Health. U.S. National Library of Medicine, 18 Dec. -0001. Web. 12 Apr. 2012. <;.

What Are the Health Risks of Overweight and Obesity?” – NHLBI, NIH. Web. 08 Mar. 2012.

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