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New anti-obesity drug dismissed by FDA panel

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diet drugs that have been rejected by the fdaThe troubled path of diet drugs continues to look challenging, especially after a U.S. Food and Drug Administration (FDA) panel recommended Thursday that the agency not approve a new anti-obesity medication—the second of three to come up for evaluation this year.

The new drug, called lorcaserin, acts on the brain’s serotonin, a neurotransmitter involved in appetite, digestion, memory, mood and other functions. Serotonin also plays a role in the cardiovascular system, and the diet drug fen-phen (fenfluramine and phentermine) was pulled from the market in the 1990s after it was linked to heart valve problems. When given in high doses, the new medication also gave many rats tumors (though human trials have not been linked to increase cancer risk). "In my opinion the potential risks of the medication outweigh the potential benefits," Heidi Connolly, a panel member and professor of medicine at the Mayo Clinic, told Bloomberg News.

Other committee members, however, pointed more to a questionable level of efficacy than concerns over safety in their final vote, which was nine to five against approval. "I really didn’t have a lot of issues with the risk," Eric Felner, a panel member and pediatric endocrinologist at Emory University, told The New York Times. "I just didn’t see it as being that efficacious."

The FDA requires new diet drugs to help people lose at least five percent more of their body weight than a placebo. Those on the lorcaserin lost about 3.3 percent more weight than those on the placebo, according to the Times. But the drug did meet another FDA criteria that at least twice as many people taking the medication (versus those on a placebo) lose five percent or more of their weight.

Qnexa, another diet drug, was voted down by the committee in July. And the panel is slated to assess the drug Contrave—the last of the three new possible treatments—in December, the Times reports. Although the FDA is not required to follow the suggestions of the advisory panel, it often acts on its decisions. The company that makes lorcaserin, Arena Pharmaceuticals, will continue to pursue FDA approval, Arena CEO Jack Lief told Bloomberg, and the agency’s decision is anticipated to come in October.

Many observers of the diet drug field remain skeptical that a pharmaceutical panacea for the growing obesity epidemic will emerge anytime soon—despite widespread obesity and big incentives to develop a blockbuster drug. Another possible setback for the field: Meridia (sibutramine), a drug that is already on the market, might be pulled from shelves in the U.S. as it already has been in Europe. Its use has been linked to stroke and heart attacks in those who already have elevated risks, and the FDA panel was split (eight to eight) in a September 15 vote as to whether to stop its sale.

Image courtesy of iStockphoto/FotografiaBasica





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  1. 1. jtdwyer 2:53 pm 09/20/2010

    The article states:
    "The new drug, called lorcaserin, acts on the brain’s serotonin, a neurotransmitter involved in appetite, digestion, memory, mood and other functions. Serotonin also plays a role in the cardiovascular system, and the diet drug fen-phen (fenfluramine and phentermine) was pulled from the market in the 1990s after it was linked to heart valve problems."

    Drugs that act like a shotgun on neurotransmitters having influence on a diverse spectrum of brain processes should be considered by their very nature to be dangerous. At best it would seem that they must produce a wide range of side effects – whether identified in test results or not.

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  2. 2. GoodWithoutGod 3:04 pm 09/20/2010

    There are two drugs readily available that, combined, are 100% effective in combating obesity for the vast majority of obese people: exercise and diet.

    I know there are people who have medical conditions which cause obesity, but I believe the majority of obese Americans (and Canadians) are just plain, flat-out LAZY!

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  3. 3. jbairddo 4:18 pm 09/20/2010

    Exactly, which ties into the myth that having insurance and access to physicians is an alternative to actually taking care of one’s self. There are now genetic tests which can tell people accurately whether they should be on low fat or low carb diets and studies have shown this method to provide a great deal of weight loss. Time to remove the time honored notion that all calories are the same and all diets should work the same.

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  4. 4. yjacket32 10:36 pm 09/20/2010

    "The new drug, called lorcaserin, acts on the brain’s serotonin, a neurotransmitter involved in appetite, digestion, memory, mood and other functions. Serotonin also plays a role in the cardiovascular system, and the diet drug fen-phen (fenfluramine and phentermine) was pulled from the market in the 1990s after it was linked to heart valve problems."

    Sorry to use the same quote, but this poses a very serious question in my mind. Are we really willing to sacrifice the people we are for the pursuit of a better image? I mean, if we take a drug that can change our memory and mood and cause us serious health issues that are probably worse than the fact that we are a little overweight, what does that say about our value of life? Do we honestly value the way we look on the outside more than we value our internal health and personality? In my opinion, this says more about society’s values than anything. We teach our people through art, music, science, books, and even medicine now that it is completely o.k. to change who you are just so you can look better on the outside. In truth, the outside doesn’t even really matter; it’s the heart on the inside that has the power to drive and motivate others to be better. I think that if we want a healthier population, we need to stop feeding people the lies of materialism and start telling them that they’re worth more than what they look like to a stranger. Only when people have a strong self-confidence will they be motivated to truly take care of themselves through a proper diet and exercise (which, GoodWithoutGod, I do think is that best way to physically fix this situation).

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  5. 5. intelfam 4:43 am 09/21/2010

    yjacket32, I think you may have a point worth a lot more thought. Where do we get our self-esteem? By conforming to the standards projected at us from outside and, I would say, it follows, that the greater the volume and frequency of messages, the more is the pressure to conform. That sounds obvious, but as somebody who changed career from commerce and industry to social work, I realise that my self approval was no longer measured against quite artificial criteria, which I had gone along with, which included appearance and other factors which had nothing to do with me as a person. When I started to get feedback from folk I genuinely helped and who didn’t care much about irrelevant things, I felt that their standard and means of measurement was far more meaningful. Maybe our self obsession has it’s own reward?

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  6. 6. neilrued 6:52 am 09/21/2010

    I have been overweight since I was a child, and have been the target of much prejudice, from people fortunate enough to have been born with genes that give their bodies "normal" proportions. I have been told by many people over the decades that I am lazy, irresponsible or that I lacked self control.

    I have been disadvantaged in various workplaces and even though the quality and quantity of my work was of the expected company standard, I was always told my work was not good enough or I was given the jobs the lean people did not want to do. I have been marginalised and treated like a second class citizen since my school days and later on in my working life.

    Even when I was attending University, I found it hard to find a lab partner or project partners because I was overweight. Lean or athletic lecturers or tutors would treat me with derision or felt annoyed I’d ask questions, and would give me laconic vague answers.

    I did at one stage exercise and lost enough weight to be within 5kg of my ideal weight. I was astounded at how lean people would treat me with kindness, and would actually talk to me. I felt so disgusted at the hypocrisy of lean people, that I stopped exercising because deep down I was still the same person. I allowed my weight to increase because I resented myself more to fit my body image to become one of "them". The irony is that whilst I was leaner, I looked at overweight people and started seeing them through the same hateful eyes as other lean people used to see me as; I then realised I’d become one of the enemy.

    A British author is correct when s/he wrote "Obesity is the last acceptable form of prejudice".

    Those lean people who lash out and say or write that obese/overweight/fat people are lazy, and that the only two drugs required are diet and exercise, are misguided ignorant individuals who spout too much B.S. and not enough facts.

    Diet and exercise are not drugs; I wish people would quit writing such stupid comments, and allow those who are wiser and truly knowledgable contribute to finding real solutions based on Science, and not primitive mumbo jumbo.

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  7. 7. organismASaWhole 1:45 pm 09/21/2010

    "I did at one stage exercise and lost enough weight to be within 5kg of my ideal weight. I was astounded at how lean people would treat me with kindness, and would actually talk to me. I felt so disgusted at the hypocrisy of lean people, that I stopped exercising because deep down I was still the same person. I allowed my weight to increase because I resented myself more to fit my body image to become one of them"

    What does being lean and healthy have to do with being one of them? Just because you lost weight does not mean you will become judgmental against your will. If anything having been over weight should have made you more sympathetic to the plight of fat people. Having achieved your goal though you admit to looking at fat people with resentment. What does that say about your mental state? It says that you maybe also lack the mental ability to have the discipline needed to keep your body healthy. I also think that a lot of fat people use food as comfort cause they lack other satisfaction in their lives.

    It could also be that we have an innate ability for the predicate of over weight people…

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  8. 8. organismASaWhole 1:47 pm 09/21/2010

    edit should read prejudice not predicate :-)

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  9. 9. HealthyJournal 2:11 pm 09/21/2010

    For years the potential risks from diet pills have been discussed. However, this "solution" to obesity continues to gain huge revenues in the Diet & Fitness industry. Have you heard of another pill being reviewd by the FDA, Appexium (aka Linee)? It may get rejected too due to possible risks and dangerous side effect (vision impairment, birth defects, depression etc.). Healthy weight loss through proper diet and exercise needs to be at the forefront of the solution to obesity, not a "magic pill".

    Sara
    Read about Appexium here: http://bit.ly/bIrAni

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  10. 10. nfiertel 2:50 pm 09/21/2010

    The way to lose weight is to drop out of one’s diet the one addition to it that has caused the obesity in the first place..simple carbs in their multitudinous varieties from breads and juices to pop and chips, fries, waffles, health drinks made with honey and so forth. Eat your fruit. Don’t drink it is a wise axiom. Skip the nonsense about whole grain breads as they do not slow down absorption of carbs which immediately turn into glucose and go right to the liver to be turned into abdominal fats. Having studied much of the scientific evidence on line which showed blood glucose measurements after meals it is obvious that 99% of medical advice in any of this is not based upon real evidence but assumptions that are sadly incorrect. Our genotype requires that we eat protein and fat based foods and vegetables and not farm grown grains, processed fruits in the form of juices and so forth but rather high fiber sources such as whole vegetables and fruit, meat and eggs ( and yes, animal fats included in reasonable quantities).Along with these we need high protein nuts and soy beans, legumes and the like all of which have substantial fibre to slow the absorption of their smaller carb footprint. You can say, what does the writer know of any of this? He has in fact changed his diet 7 months ago to this regimen and has dropped from pre diabetic and very overweight to normal blood sugar and 55 lb lower without having had to starve himself. Oh yes, the HDL went up and the LDL down. This was so substantial my doctor showed the results to his medical students to show how diet can impact on one’s health. One does not need a magic pill. One needs to realise that we have been fed commercial oriented nutritional advice that is killing us..the so called health choices, the low fat nonsense, no eggs, no full fat milk products, low meat and high carb diets. Of course NO trans fats at all ever.They go on and on..Instead think of yourself as a hunter gatherer..which is exactly what we are in fact. Eat that sort of stuff and you will do yourselves a big favour.

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  11. 11. cferguson 6:32 pm 09/22/2010

    the truth is that the risk (by far) outweighs the potential benefits, and it is questionable that the benefits are actually safe themselves, so is the benefit even a benefit, or a risk? It also seems ironic that the FDA is looking out for the health of the consumer, but refuses to pass a weight loss drug unless it makes its consumers lose more than 5% weight than those taking a placebo. It seems like rapid weight loss is a preferred criteria for the drug, which is arguably not a safer method. These kinds of things need to be thought about, not simply tested for facts and data. Can we ask ourselves at this point, how much is the FDA ACTUALLY looking out for us?

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  12. 12. tech12 9:40 pm 09/22/2010

    GoodWithoutGod, I am in complete agreement with your comment about the best drugs being exercise and diet. I think people use the obesity statistics of the nation as an excuse to hide behind their unhealthy lifestyles – it’s the `if everyone’s doing it, why can’t I?’ mentality. Diet pills simply give people more of a justification to be lazy. Though I do believe that some people have medical conditions that hinder their ability to avoid obesity, the majority of people are indeed, lazy. I’m sure everyone can think of someone in his or her life who isn’t living healthy, and has gained weight as a result. No matter what the cause, there is no true excuse, when much of the rest of the world finds a way to stay healthy. The next generation will surely follow our example. In a study performed by the CDC, childhood obesity in 2-5 year olds increased from 5% in 1976-1980 to 10.4% in 2007-2008. Numbers for children between 6-11 years of age increased from 6.5% to 19.6%, and 12-19 year olds increased from 5% to 18.1%. * Do you really want your children to have weight problems and self-esteem issues? Get some exercise; improve your lifestyle, and in turn, those of the next generations’.
    *http://www.cdc.gov/nchs/data/hestat/obesity_child_07_08/obesity_child_07_08.htm

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  13. 13. celia88 4:04 pm 09/23/2010

    As a student majored in biology, I definitely do not approve the idea to take medicine to lose weight. Diet drugs act on the brain to control appetite, digestion and memory. This will sure make side-effect on the body, which will cause too much burden for other functions. It is like hitting the pipe, makes people addict to it. In the long term, the diet drugs will endanger people’s health. One of my friends used to take diet drugs for 2 years, this sure makes her skinnier, but also sick in bed all the time. She is easy to get a cold or affected by germs only because the diet drug hurt her body functions. She looks prettier now, but she can’t even go out as she want, do any sports or some `crazy’ things with her friends anymore. What she lost is way more than she got. In addition, people don’t make friends or judge others only based on their appearance. What is more important is your heart, your mind, the value inside. It is ok if you don’t look pretty, but knowledge and kindhearted will make you charming and attractive as well. So, there is no need to take risk of your health to look skinner, we should use proper diet and exercise to lose weight.

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