Our ancestors lived in a feast or famine world. When you don't know where your next meal is coming from, or when it will arrive, the smart play is to pig out every time food is available. Our genes are programmed to extract as much energy as possible from what we eat and to store any extra energy in fat reservoirs, available in reserve for future famines.
These deeply ingrained genetic tendencies worked great in the austere world of our ancestors, but are a disaster in our current world of refrigerators, ubiquitous fast food joints and milk shakes.
Only one third of Americans are now able to maintain a normal weight; one third are overweight; and one third are obese. Excess weight is a risk factor for most illnesses, and for many people is also a consuming cosmetic concern.
Pharma knows that a safe and effective diet pill would be one of its biggest potential cash cows. Over the past 80 years, drug companies have done extensive research and have developed many products trying to capture the enormous market of unsuccessful weight watchers. None have worked well; all have had considerable risks.
But hope and hype always spring eternal. Dick Bijl is the perfect person to describe this troubling story and provide much needed cautions against our future credulity. He is president of the International Society of Drug Bulletins, representing 53 national drug bulletins, each engaged in evaluating the pluses and minuses of medications. Drug bulletins are essential-truthful antidotes to the misleading falsehoods turned out by the Pharma propaganda machine.
Dick writes: "The rate of overweight and obesity in adults and children is increasing rapidly all around the world. This results from a long lasting energy imbalance -- people who take in more calories than they burn. Being overweight increases the risk of cardiovascular diseases and certain types of cancer -- and of death related to these diseases.
Desperate consumers eagerly turn to fad diet programs and diet pills to obtain weight reduction. But treatment for overweight is difficult, the results are poor and the risks are great.
The FDA has an extremely low standard in approving weight control drugs -- all they have to demonstrate is a weight loss that is statistically different from placebo -- but the weight losses the meds actually achieved have always been very small and usually vanish almost immediately after stopping the drug. It is doubtful whether small statistically significant differences in weight are at all clinically relevant in promoting any real health benefit.
History has also shown that diet pills can cause severe, and sometimes even fatal, side effects that appear only after approval and that force them to be taken off the market.
In the 1930s, Dinitrophenol was introduced as a safe and effective drug for weight loss in the USA and Europe. Its mechanism of action seemed ingenious- cells were made less efficient in storing energy and instead burned it off as heat. Soon hundreds of thousands of people were using the new wonder drug. But after just four years, dinitrophenol had to be taken off the market as doctors noticed that many patients lost their vision, completely or partially, through cataracts.
Others suffered from renal disease or died because of fatally increased body temperature. Of note, these harms haven't stopped some reckless body builders, who still use the substance despite its risks.
The basic message from the disaster that followed the introduction of this first approved diet pill should have been clear -- careless tampering with our body's energy system can be dangerous.
This lesson has never been learned. The same scenario of groundless hope, disappointment, and damage has been repeated over and over again.
In the 1960s, aminorex was the promising new diet pill, but it led to pulmonary hypertension.
In the 1970s, dexfenfluramine was the great hope, but it caused disorders of cardiac valves.
The market-authorization of rimonabant was withdrawn in 2008 mainly because of psychiatric side effects.
The market-authorization of sibutramine was suspended in 2010 because of severe and sometimes fatal cardiovascular side effects.
Phentermine and fenfluramine have been used for the treatment of obesity, but gave rise to pulmonary hypertension and disorders of cardiac valves.
The balance of efficacy and side effects of orlistat, now the only registered and available weight losing drug in the EU, is also not positive. This drug has only marginal efficacy, often leads to gastro-intestinal side effects, and sometimes causes severe liver damage. Recently, it came out that the reporting of side effects in orlistat publications was systematically understated.
The combination of topiramate and phentermine has been approved in the U.S.A., but not in Europe -- because of serious doubts regarding long term safety.
Recently two products were granted approval for the treatment of overweight: naltrexon/bupropion (an opioid antagonist and an antidepressant) and liraglutide (which already was approved for diabetes mellitus). These produce only minor weight loss of four to five kgs -- not worth the long term risks of side effects.
There are also lots of herbal preparations promoted as safe and effective in weight control. Great caution is necessary because they are not intensely studied before entering the market, or carefully monitored after. And safety and efficacy are both doubtful. In the past, many preparations contained ephedra, which can cause cardiovascular problems (hypertension, arrhythmia, myocardial infarction) and central nervous system side effects. In Europe and the USA, it is now forbidden to market preparations that contain ephedra.
It would be a great benefit to the world's health and fitness, if an efficacious and safe weight losing drug became available -- but at this moment weight control with drugs remains an illusion. It must be recognized that diet pills have so far produced meagre benefit and lots of bad complications.
The lasting effects of non-drug interventions, like counseling on diet and physical training, have also proven to be small- but they are safe and remain the first option in treatment.
The solution of the obesity-problem does not lie in the consulting room of the physician or in the pharmacy, but must be focused on prevention and changes in lifestyle."
Thanks, Dick, for reminding us that there is no mystery to achieving healthy weight -- and no shortcut. A long term dedication to proper diet and regular exercise are crucial to any successful weight control program. Diet pills are an attempted short term fix that doesn't work and may cause a great deal of trouble.
And be skeptical of future diet pills that enter the market with extravagant claims. If a pill solution to overweight were easy, we would already have it.
There is no low hanging fruit, no easy answer.
Many promising scientific discoveries have been made revealing the brain and gut mechanisms regulating appetite and weight. But the treatments derived from them never work because each addresses only one simple target in a very complicated system. Maintaining weight in the face of famine was so essential to the survival of our ancestors, going back millions of years, that we have many inbuilt, overlapping, redundant systems to ensure that we use energy efficiently and develop fat stores whenever possible. Try to change the workings of one system with a diet pill and others kick in to restore the previous balance.
And a remarkably delicate balance it is. Eat just one extra candy bar a day for a year -- a very easy thing for me to do -- and you gain thirty pounds. In a world that ubiquitously offers ridiculously tempting food choices, gaining weight is for most of us the inevitable default position.
So how can we fight the good fight against overweight without resorting to diet pills?
On a personal level, the only answers are insight into the absolute necessity for lifestyle changes, combined with the discipline to effect them.
On a national level, we must target being overweight as our number one public health risk and number one policy priority. Stop subsidizing the sweetener makers; start subsidizing veggie products. Make exercise and good dietary habits an essential part of the school curriculum, recess periods, and lunches. Give tax deductions for exercise equipment and gym memberships. Spend more public dollars on weight control programs and fewer on medical treatments.
There is not a pill for every problem. As individuals and as a society, we must face the fact that weight control in a time of plenty will be an ongoing and never ending struggle- but one we cannot safely avoid.