I often hear the statement “supported by clinical trials.” Yet, I always thought that was vague. I wanted more detail. Let’s begin with a basic definition: A clinical trial is a research study involving human volunteers. Clinical trials assess the safety and effectiveness of new ways to diagnose, prevent, or treat a certain health condition. They also provide insight about the disease process, and how it might be treated. Clinical trials are a vital part of the scientific research process and are essential to developing better treatments for people with certain afflictions.
According to fda.gov, the following different types of clinical trials are used depending on what the researchers are studying:
Treatment: generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
Prevention: seeks better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic: refers to the practice of looking for better ways to identify a particular disorder or condition.
Screening: attempts to find the best ways to detect certain disorders or health conditions.
Quality of Life: explores ways to improve comfort and the quality of life for individuals with a chronic illness.
Genetic: attempts to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on a patient’s genetic make-up.
Epidemiological: seeks to identify the patterns, causes, and control of disorders in groups of people.
I love the natural products industry. And I truly love when I see compelling new science generated on a natural compound via one of the aforementioned models that has a dramatic impact on the people that take natural products. And I genuinely believe the science our industry generates is unsurpassed.
That said, the almighty dollar drives some to push the envelope. The vast majority of new product launches will be marketed as “backed by solid science.” That may be true. But many companies rely on “borrowed science” to market their new products.
In other words, companies often cite references that show that an ingredient in their product has a desired effect. But are they actually doing studies with their product? And, if they are, what would be the course of action if the product didn’t work. If a product does not show efficacy in a clinical setting, it shouldn’t be marketed, despite the money spent on the study, which, by the way, is very, very costly.
We all remember the when Merck Inc. pulled the arthritis drug Vioxx off the market in 2004. The company’s one-time best seller became closely associated with patient heart attacks. Some even allegedly argued that the company hired writers to create medical publications that their scientists are believed to have written. Many of these publications claim to be based upon the same scientific evidence that supposedly documented the safety of the drug in order to obtain approval from the US Food and Drug Administration (FDA) for distribution. Is this considered real science or marketing science?
What do I mean by “marketing science”? In an effort to generate a Return on Investment (ROI) as soon as possible, some companies will do a clinical study with their products, but design the study solely with marketing in mind. They create an outcome so they can make a marketing claim. This marketing claim will often have a direct impact on sales. This is a practice that is more common than many realize. I understand the rationale. But don’t claim to be a science-based organization if you are cutting corners to make a buck.
Moreover, according to medicalnewstoday.com, a recent probe of internal documents held by the FDA revealed official action taken by the agency due to “significant departures from good clinical practice” against a total of 57 clinical trials, including 22 of these clinical trials affected by “falsification”. Interestingly, a parallel search of the published studies finds no mention of these grave concerns being made public. What can this be attributed too? Marketing science? Something else? Regardless, this is alarming.
I have taken a wide range of supplements for decades, including probiotics, CoQ10, multivitamins, protein powders, nitric oxide boosters, adrenal formulas, joint formulas and many, many others. Thankfully, I have the background to make smart supplement choices. Many of those choices are made by my meticulous review of the science. However, to many consumers, keeping track of the research on vitamin supplements can be an exercise in frustration. Different studies on the same dietary supplements often present conflicting information.
Consider taking a closer look at the study design. This often reveals inconsistencies. The Harvard School of Public Health offers the following that may help you put conflicting results into context:
What vitamin doses did study participants take and for how long: The most obvious source of conflicting study results is that different studies test different doses of supplements, for different lengths of time.
Study participants and lifestyle choices: We all know that exercise and healthy eating positively impacts health and that smoking negatively impacts health. These lifestyle choices can also have a profound impact on how the body absorbs dietary supplements. A supplement is called a supplement because it supplements your diet. Dietary supplements are only useful to people whose diets are lacking in that specific nutrient. Therefore, a randomized, placebo controlled trial utilizing dietary supplements on people who eat well may generate deceiving results.
Time of consumption: A supplement may only be beneficial at a particular stage of a health condition. So, studies done at different stages of a particular health condition may yield inconsistent results.
Measuring efficacy: Studies often differ in how results are measured. For example, what conditions associated with heart disease did a study using CoQ10 impact: heart attack, stroke, or vascular disease. Or did the study measure CoQ10’s impact on heart disease in general. You see my point.
A supplier or marketer can firmly cement its reputation as a legitimate natural products player by generating science that is truly unbiased and science-based. This will not only build immeasurable brand equity but will provide the desired result: a genuine natural health solution with proven efficacy. After all, isn’t that what it’s all about?
Mark Becker is the EVP, Sales and Marketing for Allied BioNutrition Corp., a global biotechnology leader, based in Los Angeles, CA. He has worked as a natural products sales and marketing executive for 20 years. Mark has written more than 300 articles and has hosted or been a guest on more than 500 radio shows. He obtained a bachelor’s in journalism from Long Beach State University and did his Master’s work in communications at Cal State Fullerton. For more than 30 years he has participated in numerous endurance events, including more than 150 triathlons of Olympic distance or longer, 103 marathons and numerous other events including ultramarathons and rough water swims from Alcatraz to the mainland. He has relied on a comprehensive dietary supplement and homeopathic regimen to support his athletic, professional and personal endeavors. Follow Allied BioNutrition on Facebook at https://www.facebook.com/AlliedBioNutrition11/?fref=ts. Follow Mark on Twitter at @AlliedMbecker. For more information, access www.AlliedBioNutrition.com.
