When Phen-fen was approved by the FDA for prescription use, weight loss hopefuls flocked to doctors nationwide until over 18,000,000 Phen-Fen Prescriptions were written. Personal Trainers were besieged with conflicting information regarding the new weight loss pharmaceutical. It became difficult to distinguish truth from hype. While most qualified fitness professionals were able to infer that there's something inherently wrong with a pill that promises to do what we know can only be achieved through proper nutrition and exercise, the pharmaceutical and medical literature came out with blaring praise of this new "miracle solution."
Hard Copy sent a crew to my home to conduct an interview about the dangers of Phen-Fen days after somebody died on the operating table from complications incurred during excessive liposuction surgery. The segment topic was "The Dangers of Desperate Weight Loss Solutions." After meeting with numerous Phen-Fen victims, and collecting valid information from a multitude of biochemists and pharmaceutical experts, I was prepared to explain to the television audience some of the Phen-Fen realities. As the cameras rolled I explained that Phen-Fen is actually the combination of phentermine and fenflouramine which, in combination, alter neurotransmission of serotonin and dopamine so appetite is virtually switched off. While initiating a stimulant effect, the drug combination had the ability to alter brain signals to minimize the sense of raciness associated with amphetamines. The Physicians Desk Reference lists one side effect of the Phen-Fen drugs as "possible short term memory loss." Interestingly enough, Phen-Fen affects the same neurotransmitters as cocaine. When we discuss the potential side effects of cocaine, rarely do we hesitate to use the term "brain damage." When a substance is being promoted to feed the financial health of the pharmaceutical and medical communities, the terminology is altered to "possible short term memory loss." I also explained the correlation between Phen-Fen prescriptions and incidence of Primary Pulmonary Hypertension. In most cases, those diagnosed with PPH have two options. Death or a complete heart and lung transplant with death likely in the near future.
Here's the shocking part. The day the segment aired I received over 200 phone calls from people asking where they can get Phen-Fen! I spoke about life threatening side effects, yet Americans are so desperate for weight loss at any expense . . . . my phones rang for days with callers begging for Phen-Fen sources!
After several Phen-Fen related deaths, the FDA began steps to determine whether this truly was a safe weight loss alternative. They soon after determined it wasn't and pulled it from the market. Luckily Personal Trainers were not allowed to disperse Phen-Fen. It was classified as a drug and could only be obtained with a medical prescription.
Is it fair, therefore, to state that Personal Trainers are not allowed to prescribe drugs? In a field that's unregulated, the answer to that question is unclear as you'll soon see.
On June 29, 1999, according to an AP release, a $320 million dollar lawsuit was filed against a New York City fitness facility and one of its trainers for "recklessly" prescribing nutritional supplements. Ann Marie Capati, a 37-year old fashion designer, suffered a stroke on October 1, 1998 while working out after ingesting "fat burners" prescribed by her personal trainer.
Whether or not the trainer can be held liable, I believe it's important for both trainers and their clients to summon up a bit of self regulation as we come to realize the possible ramifications of what might appear to be simple supplement recommendations. Should trainers recommend supplements? I won't share my opinion here, but rather open up the question so that fitness professionals can begin to think carefully about the boundaries of their professionalism and their potential liability.
About 10 years ago bodybuilders found that the asthma medication, clenbuterol, seemed to aid release and appeared to act without compromising muscle tissue. I will go out on a limb to say that I've personally heard trainers recommend that their bodybuilding clients use the drug. It wasn't long before abuse led to federal regulations classifying clenbuterol as a Class III drug. In bodybuilding circles, recommendations may not have ceased, but since this was an "underground" recommendation, in the case of drug related injury, liability would be difficult to prove. Is it fair to surmise that a trainer, therefore, who recommends legal and OTC supplements may be at greater risk than those who ignore the law in their recommendations?
While clenbuterol was finding underground popularity, a study was providing evidence that the combination of two OTC drugs, caffeine and ephedrine, can aid in the quest of weight reduction. The study was published in the Journal of Obesity and it wasn't long before caffeine:ephedrine combinations were springing up under varied labels throughout the bodybuilding and weight loss communities.
It's important to note that while caffeine and ephedrine were both available in most drug stores without prescription (i.e. Vivarin and Primatene tablets), they are drugs and with drugs come the risk of side effects. It was soon noted that aspirin, another OTC drug, may potentiate the "thermogenic" effect of the caffeine:ephedrine mix and the major supplement companies scrambled to release and position their own thermogenic formulas.
The marketers of products found that the words, "herbal" and "natural," from a marketing standpoint, are more appealing to the general public than words we usually associate with drugs.
We can extract the drug caffeine from several herbs including Guarana, Kola Nut, and Green Tea. We can extract ephedrine from the herbs Ephedra or Ma Huang. Aspirin (salicylic acid) is a derivative of White Willow Bark. Herbal formulations emerged in every health food store and gym containing this "thermogenic" blend. Here's the hole in the legality of "drug prescriptions." Since these drugs were over the counter, and since the herb combinations can legally be sold in any health food store, no law appeared to prevent Personal Trainers from "prescribing" these drugs to their clients.
As I mentioned, drugs do come with side effects. The side effects of ephedrine range from headaches and tremors to stroke and death. Combine ephedrine with caffeine and you create an addictive combination with heightened risk. Don't get me wrong. These formulas have their place. Whether or not that place is over the counter, a bit of education is in order before anyone prescribes any drug to anyone else.
As the medical community struggles to offer sound weight loss advice, the public is seeking out alternatives to conventional medicine. In seeking out a Personal Fitness Trainer, the public is lead to believe "certification" is the equivalent of "qualified." Is it? No law says otherwise. Here I will offer my opinion and publicly state that "credible certification" is only a small piece of "qualifying" to direct others in quest of health and fitness.
Despite my opinion, well intentioned trainers nationwide hand hundreds of thousands of bottles of "formulas" across the counters of countless stores and health clubs with very little regulation. One of the clear-cut contraindications for ephedrine is hypertension. Did the New York trainer know his client had hypertension? If so, is he more liable for the fatality? Should he be held for a higher level of negligence if he neglected to establish whether there were pre-existing medical conditions? The real question here is one of competence. Is a trainer competent to suggest or prescribe OTC products?
This article is not intended to pass judgement, but rather to bring to the forefront some questions that beg to be answered. The article is further intended to encourage the many Personal Trainers that read this publication to strengthen their positions as professionals by examining some loopholes that have come to light, by recognizing their own exposure, and by responding accordingly.
As Fitness Professionals, we are taking on a great responsibility when we commit to help any individual improve his or her body and health. I'd suggest that every trainer practice three very powerful words. "I don't know." If a client asks his or her trainer whether a drug, product, or untested formula is safe and effective, it's OK for that trainer to remain a specialist in the area in which he or she was trained. Ann Marie Capati might be alive today had she received a bit of education on the dangers of the supplements prescribed or had her trainer stayed within the boundaries of exercise prescription.