When Will They Believe?

 by Phil Kaplan

When the overweight segment of our population, estimated at just short of 70% of Americans, finally believe that they have the power to lose fat and reshape their bodies with some degree of permanence, the pharmaceutical companies will have to turn their primary focus to curing disease.  The question is, when will they believe?  The answer, based on recent history seems to be, “not any time soon.” 

In order to change a belief, people need new perspective and the beginning of a shift in perspective may come from the acceptance of an influential statement as fact. 

Here’s a fact.  The pharmaceutical companies who have invested in bringing “weight loss drugs” to the marketplace have succeeded in generating hundreds of millions of dollars.  Here’s another fact.  Not a single one of the weight loss drugs proved to be safe and effective.  Not one. 

I’ve written and spoken on the Fen-Phen combination far too long, and I’ve continued to do so only because it provides a clear illustration of the contradiction between research and suspicion of risk and the FDA’s willingness to provide a stamp of approval. Fen-Phen wasn't a drug, but rather two drugs used in combination. The drugs were not new to the market in 1994 when they started finding their way to 6 million Americans heading to their pharmacies with doctor-written prescriptions. One of the drugs, Phentermine, was approved by the FDA more than 40 years ago. It was prescribed as a weight loss drug, but with disappointing results. The drug was to be used for no more than three consecutive months. The reason? It appeared there was a very real risk of developing heart valve problems. Fenfluramine was approved in 1973, two decades before the two were combinted and it came with similar outcomes and similar warning. If each drug, independently, is identified as a potential threat to the circulatory system, any 5th grader would extrapolate the obvious. The two drugs together, taken for a longer period of time, increases the risk significantly. When the incidence of PPH, a life-threatening circulatory disease, became alarmingly prevalent among Fen-Phen users, the FDA had the combination pulled, but they approved dexflenfluramine (Redux), a version of "Fen" touted as being free of risk. Two years later, Redux was pulled as it was suspected to be responsible for PPH related deaths.

To make matters worse, continued research indicated that the Fen-Phen drugs were neurotoxic and brain injury had occured in many Phen-Fen users. Continued animal studies demonstrated that serotonin (5-HT) terminal degeneration was a replicable outcome. In other words, in addition to screwing with your cardiovascular system, the drugs led to a reduction in serotonin production which comes with a long list of undesired outcomes.

Here's the question that begs to be asked. Should we, consumers, believe that FDA approval equals safe and effective?

The Parade of Promises

There’s been a continuous parade of what can only be described as an obvious planned obsolescence, a willingness to bring forth promises of weight loss with the knowledge that each release has a limited time span before the consumer marketplace gives up on it.  While a drug is finding its way out of the marketplace, doctors are being courted by pharmaceutical reps touting the next drug on the horizon. 

The research continues.  We’d like to believe it continues in a quest to find a solution, but the patterns that are becoming clear seem to suggest it’s more of a quest for a best seller. 

Beyond Fen-Phen and Redux, the weight loss marketplace was seduced with Pondomin, Meridia, and Xenical.  Xenical fell short of promises, but Glaxo took an ambitious and savvy turn.  They reduced the dosage, applied to sell the drug over the counter, and pulled together a marketing campaign that played up “eat right and exercise.”  The end result?  Alli hit the market with an explosive (no pun intended) presence and, at best, questionable results. 

In the meanwhile, research continues to find a pill or capsule that will access the leptin pathway to increase satiety and suggest that people may achieve the same outcome as genetically altered rodents.  The effect has not, to date, been proven in any oral drug compound and the early studies with humans suggested interruption in pancreatic insulin production. 

Another drug, Accomplia, is sold in Europe and appears to be resulting in weight loss.  Sanofi, the pharmaceutical company, petitioned the FDA to get the drug approved as a cure for metabolic syndrome.  The research was less than promising and far from conclusive and the FDA turned thumbs down.  My guess is, that’s only the middle of the story.  The drug will be resubmitted, now as a treatment for obesity. 

Exploration is becoming aggressive as research shows promise in a compound referred to now only as E-6837.  The excitement begins when researchers identify a target, and since pure CNS stimulants are old school, falling into the category of amphetamines complete with jitters and insomnia, further exploration of the central nervous system reveals the actions of specific neurotransmitters and the receptor sites upon which they act.  The messenger – receptor link has been analogized to a key and lock.  Only very specific chemicals can access the receptor bringing about a specific action at the cellular level.  Rats treated with E-6837 seemed to lose more fat than control groups.  This chemical compound appears to act by modulating the 5-HT₆ receptor.  This receptor is a pathway to the production of serotonin so continued exploration is going to attempt to prove a weight loss mechanism activated with the 5- HT₆ receptor can be activated with yet a new drug. Considerations as to the long term ramifications of altering serotonin via this receptor will likely only be considered, as in the case of Fen-Phen, after a drug is released and people suffer ill effects.

Waiting for Rescue

I understand the hope.  I understand the perceived promise of research.  That’s why I’m about to switch gears, perhaps to get you to open up to the possibility that the “eat right and exercise” formula will work for you, far better than any weight loss drug. 

The Short Story of the Deadbeat Neighbor

Suppose you lend $20 to a neighbor who promises she’ll pay you back in a week.  Two weeks later, you address the loan and she asks if you could lend her another $20, assuring she’ll pay you back the $40 in full come the first of the following month.  She avoids your phone calls and three months go by.  Finally you run into her in a restaurant.  She hugs you, tells you how glad she is that you showed up, and explains that she doesn’t have enough to pay the check.  She apologizes and pleads for another $5 loan, promising she’ll pay you back the following day.  When she avoids your calls for another three months, you would call upon common sense and draw some conclusions based on her history.  You accept that you may never again see your $45, but you vow that you will never lend her money again. 

Why, if you agree with the previous paragraph, would you trust an industry that made a promise, failed people, made the same promise with another drug, failed people again, and continued this process ad infinitum?  Because you’re caught up in the flawed belief that you need rescue in pharmaceutical form.  If you are, in fact, caught up, you do need rescue, but the only rescue you need is fitness truth and a willingness to make some simple shifts in the way you eat and the way you move. 

I could write this same article replacing the references to drugs with references to reduced calorie diets.  Why, when diets continue to fail people, is our population desperately searching for the next diet?  It's easy, almost trendy, to blame people for their poor dietary habits, and to riddle them with guilt for their inactivity, but they may not to blame, at least not as a primary cause. These developed habits are often driven by shut-down belief systems that drive people to find pleasure in foods that may drive a short-term serotonin spike at the expense of health. Obese and overfat individuals are prime victims because they don’t have a consistent and clear resource for fitness truth, and they don’t have the hard evidence that proves “eat right and exercise is better than diets and weight loss drugs” indisputably. 

Proof in the Works

I’m taking steps to provide evidence.  I started a research study addressing body composition shifts, reports of enhanced quality of life and well being, and a multi-factorial assessment of “biological body age.”  In the early stages of the study (we'll track participants through 6 months and a year to assess lasting results) I've seen people reduce their biological age by 7 years! In only 21 days! Participants have experienced fat loss, metabolic improvement, and several have revisited their doctors to cut back on dosages of prescribed meds. Energy improvement is radical as is expression of enhanced self-esteem. I aim to bring attention to this study worldwide by 2010 to prove that with a valid, legitimate, sensible exercise and eating program, results can be dramatic and lasting, and in contrasting outcomes with research assessing diets and drugs, help to facilitate a population-wide belief shift. 

I invite you to send me an email sharing your experience with diets or weight loss drugs or requesting a telephone appointment to discuss going through the same 21 day program that was used in the study. If you live in South Florida and have been through a personal history of diets and/or drugs, you might consider joining me for the live programs conducted in Weston. If you live outside of South Florida, there is a remote version of the program available online.

I know, beyond the shadow of a doubt, you have the power to change.  I know, beyond the shadow of a doubt, that with understanding you can make simple shifts in the way you eat and move, and I know, beyond the shadow of a doubt, that those shifts can lead to radical improvements in your quality of life.  Now . . . I aim to prove it! 

Stay tuned!

 

Also Read: Fitness is a Cure Listen To Phil's Interview with Carol Dweck, PhD, author of Mindset Phil's Training Strategy is Detailed in: TRANSFORM! The Fitness Masterpiece The 21 Day Program

 

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