Weigh in on QNEXA

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. 13^th 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

Vitamin C Controversy

Feeling sleepy, achy and a tad congested has me at home today. As I sit drinking a cup of tea and resting to prevent whatever my body is fighting off from becoming a full-fledge illness, has me thinking of alternative treatments. I work with children with special health care needs and I regularly hear parents ask what they can do to prevent illness. The common cold or the flu may have the average person feeling miserable for maybe a week, but these sicknesses for a medically compromised child can wind up in a trip to the ER and a hospital admission. Beyond reducing exposure to germs and good hand hygiene, what else can you do?  

The controversy over vitamin C and its benefits in fighting the common cold has dominated since the 1970’s. Studies seem to be split on the ability for vitamin C, taken daily to prevent colds or therapeutically during illness, to be of any benefit. Anecdotally, people claim vitamin C to work wonders even beyond the realm of immune boosting capabilities. It is likely to be one of the most commonly taken supplements aside from a regular multi-vitamin. But do the claims stand up to evidence? And if the research is inconclusive is there really any harm in taking it?

The Cochrane Library published a review of research done on vitamin C and colds and concluded that prophylactic doses, or daily supplementation meant to prevent illness, of 200 mg or more was effective in reducing the duration of illness. The review of 29 studies found that in adults, vitamin C reduced the duration of a cold by an average of 8% and in children 13%. Placebo-controlled studies analyzing the therapeutic effects of vitamin C are few and far between. Only 7 studies were found that compared vitamin C and a placebo to cold symptoms and the results showed no significant differences in the length of illness or severity of symptoms.

While vitamin C may help, but the extent seems minimal. There are a variety of other factors to consider that many research studies do not take into account. Activity level, quality of overall diet and medical conditions all impact one’s immune system. Taking vitamin C supplements will not compensate for a poor diet or sedentary habits. Not to mention that nutrient needs vary for each individual. Lifestyle factors like stress and smoking may increase need for certain nutrients including vitamin C.

But when we look at any potential harm of supplementing vitamin C, aside from the financial cost of supplementing if you really don’t need it, the risks are minimal. Large doses of vitamin C can cause diarrhea, but decreasing the dose solves the problem.

Do I think that vitamin C is the cure-all for the common cold? No. Do I believe it plays a role in our immune systems? Absolutely. But so do vitamin A, D, iron and protein. Besides adequate nutrition, stress management and proper sleep is important as well. For myself, I’ve noticed sleep to be the primary key for staving off illness. So for now, I’ll stick with my routine of healthy eating, exercise and rest and hopefully keep this bug at bay!

References:

Vitamin C for Preventing and Treating Common Cold. Cochrane Library. March 2010.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000980.pub3/abstract

How to boost your immune system. Harvard Health Publications. http://www.health.harvard.edu/flu-resource-center/how-to-boost-your-immune-system.htm

More Reasons to Choose H2O

Drinking 2 glasses (16 oz) of water before meals may help you lose more weight! Dieters who drank 16 oz of water before each meal lost 5 more pounds than those trying to lose weight that did not increase their water intake. The reason being that water takes up more volume in the stomach right before a meal, so less food is eaten overall. http://news.discovery.com/human/glass-water-weight-loss.html

Drinking water instead of carbonated beverages may help you breathe better! Australian researchers linked soft drink consumption to asthma and chronic obstructive pulmonary disorder. This included both diet and regular sodas, the link seems to be related to the carbonation. The higher the intake of carbonated beverages, the higher the likelihood that individual had either asthma or COPD. The study looked at over 16,000 people drinking about 16 oz or more of carbonated drinks per day. http://www.guardian.co.uk/society/2012/feb/07/asthma-connected-fizzy-drinks-study

Take your body weight in pounds, divide it by 2, and that’s how many ounces of water you should be drinking a day. So for a 200 lb person, that’s 100 ounces of water a day, which is about 12 ½ cups. To give you a big picture, there are 120 ounces in a gallon… While any unsweetened beverage counts towards this amount, most people don’t get enough water. The easiest way to increase intake is to keep a water bottle at your desk and with you when running errands. Having one within arms reach will provide a visual reminder to drink more water throughout the day.

Tips to Jazz up Plain Water

1)      Add fresh fruit. Sliced oranges, limes or lemons provide an invigorating twist (pun intended!) to plain water. Even sliced cucumber or herbs like mint, basil or rosemary give a refreshing alternative to traditional water.

2)      Freeze 100% juice ice cubes. Add these cubes to water to slowly melt into plain water and provide a sweet taste without adding a significant amount of calories.

3)      Drink unsweetened tea. With dozens of flavors, unsweetened tea is probably the easiest alternative to plain water and can add beneficial antioxidants and nutrients. Green tea contains ECGC, which increases your body’s natural burn of calories. It may also protect against breast cancer! Black tea also contains antioxidants and there are various types of herbal teas that can provide additional health benefits. CAUTION: The tannins in tea impact the absorption of some nutrients. It’s best not to drink it with supplements or medications just in case.

4)      Try sugar-free, powdered flavors. There are dozens of brands and flavors of sugar-free, powdered drinks that you can add into water. While artificial sweeteners are usually involved, adding a small amount into a bottle of water (use less than indicated) will also help to flavor water and add a negligible amount of sweeteners. Do this in moderation (not every day) and rely on tips #1 #2 and #3 more often to increase your fluid intake.

Grab a glass and drink to your health!