The bad news on obesity in the United States continues to roll in with about one third of adult Americans now considered obese. Against this continuous drip feed of research data showing the scale of the emerging medical crisis, it is all the more strange that the Food and Drug Administration continues to resist approving medications such as Acomplia. It would be easy to understand this reluctance if there were already three or four major medications on the market that would help to combat the epidemic spread of obesity. But this is not the case. Acomplia would substantially add to the campaign to prevent or reduce the incidence of obesity. If this were to happen, the numbers of people suffering high blood pressure, diabetes and heart disease would be significantly reduced in the population at large. In turn, there would be less pressure to build new hospitals, staff them and equip them with the equipment and medications to treat all these conditions. This would save vast amounts of money both in insurance payments and public expenditure.
So what is the latest news? New research from the Mayo Clinic shows that more than half of American adults considered be within the normal range of BMI, i.e. between 18 and 24, actually have high body fat percentages — more than 20% for men and 30% for women. Thin people also had symptoms suggesting emerging metabolic problems and heart disorders. It is therefore clear that simply having a low body weight does not reduce the risks of heart disease or type 2 diabetes if your cholesterol levels are high. Body weight is not as good a guide to risk as lipid levels, i.e. even though thin, you can still have excessive fat. The BMI is a crude measure because it does not distinguish between body fat and lean muscle.
Given that the findings from the clinical trials show Acomplia as not only effective in reducing body weight, but also in improving the level of lipids in the blood (particularly helpful among those who already have diabetes), this latest data from the Mayo Clinic puts the decision of the FDA into more stark terms. Sanofi-Aventis will be referring Acomplia back to the FDA within the year. It will be interesting to see what its reaction is this time around.
Then, somewhat inappropriately on April Fool's Day, the Mayo Clinic also announced that researchers have been carefully studying the stools of children up to the age of seven years. This is part of a more wide-ranging project using both animal testing and human subjects to study bacteria called gut microbiota which live in our intestines and help to regulate body weight by extracting calories from what we eat and storing them for later use. Thin children do not have the same bacteria in their stools as overweight children. Similarly, laboratory mice which lack gut microbiota are always thinner than mice that have these bacteria. The researchers therefore speculate that changing the population size of these bacteria in your gut could be the key to changing your body weight "naturally".
This is a fascinating new avenue for researchers to explore and a very different approach than that taken by Acomplia which works on the cannabinoid system in the brain. The only reason we are not cheering from the announcement of this proposed treatment is the time taken to work through the process to develop a medication. It must adjust only the levels of these bacteria. There must be several more years of clinical trials to establish safety in human participants. And that just leaves the highly politicised FDA approval system still to negotiate.
In the meantime, the United States is left to fight an emerging obesity crisis without the benefit of medications like Acomplia which has been used successfully in Europe in combination with reduced calorie diets and physical exercise to reduce body weight and maintain that reduction for a year and more. Just makes me glad to be a European. Wait though, anyone can buy Acomplia online wherever they live. Must be a moral in that somewhere.