Many people have a lot of faith in their supplements; a recent survey found that 90% were confident that their supplements were both safe and effective. To illustrate just how blindingly confident we are, I will draw upon a discussion with one of my patients. I will show you that a double standard exists with supplements when compared to other medications.
The Supplement prescription
A healthy 37 year old businessman comes into my office for a check-up. I asked if he had started any new medications or supplements since our last meeting. He paused and remembered that he purchased a supplement, InflaDox (pictured adjacent), from his chiropractor two months prior. Despite having no real complaints other than a penchant for overzealous exercise, his chiropractor recommended InflaDox to help with “exercise recovery, support his joints, and improve his overall vitality”. He was instructed to take it daily in perpetuity.
I had not heard of InflaDox. However, with close to 87,000 supplements available in the United States, it would be impossible for a healthcare provider to become familiar with even a fraction of them. To try and learn more about this supplement I started by reviewing the label (see below).
The ingredients
Like a lot of supplements, InflaDox actually contained several ingredients - six in total. The supplement marketplace does not allow patents; therefore, companies combine many common ingredients to create a “Proprietary Blend” (circled in red). This helps with branding and to stand out from the crowd. For example, I would not have much luck selling you “Dr Woolf’s Glucosamine Chondroitin” because you could find Glucosamine Chondroitin anywhere. But you would be tantalized if I added a few random ingredients and called it “Dr Woolf’s Joint Formula”.
To make things more confusing, some of the ingredients in InflaDox were plant parts and extracts. A plant part or extract contains a melange of many other compounds. Like a Russian doll, the ingredients have ingredients. This makes it difficult, if not impossible, to determine all of the active ingredients in this supplement. InflaDox may actually have hundreds of active ingredients.
A plant part or extract contains a melange of many other compounds. Like a Russian doll, the ingredients have ingredients.
Nonetheless, let us focus on just one - White Willow bark (circled in blue).
What is White Willow bark?
White Willow bark is a folk remedy that dates back over two millennia to Hippocrates. It has been used for fevers and other various ailments. The active ingredient, salicin or salicylic acid, was isolated in the 1800’s. To make it more tolerable on the gastrointestinal system, it was acetylated to reduce acidity. This form, known as AcetylSalicylic Acid (ASA), was first marketed by the Bayer company in 1901 as Aspirin. Subsequently, an entire class of products, NSAIDs (non steroidal anti-inflammatory drugs), has emerged from this tree bark. This includes Advil, Aleve, and Celebrex.
Thus, White Willow bark is Aspirin. However, Aspirin has many side effects including, kidney failure, stomach ulcers, severe allergy, asthma, and bleeding complications. Does White Willow bark have the same side effects as Aspirin? Of course it does. In clinical trials, 41% of patients using White Willow bark had at least one side effect.
No warning on the label
A bottle of Aspirin contains pages of warnings. Why would a supplement containing White Willow bark extract not provide warnings? Are you starting to see the double standard? Read on…
The dosage
The InflaDox label said it contains a total dosage of 725 mg. However, the specific amount of each of the six ingredients was not listed. Supplement companies know that if they label their product as a “Proprietary Blend”, they do not, by law, have to disclose the amount of each ingredient. They can fill most of the capsule with inexpensive fillers (see OTHER INGREDIENTS circled in yellow) and use only trace amounts of the expensive active ingredients.
Thus, we have no idea how many milligrams of White Willow bark or Salicylic acid InflaDox contains. I hope you can understand that this as a BIG problem. The most essential concept in pharmacology is dosage. Going back to the sixteenth century, the physician Paracelsus observed “Only the dose makes the poison”. Meaning that any substance can quickly become a poison with a high enough dose. In modern pharmacology, the first step after a medication is discovered is to carefully adjust the dose to find the perfect Goldilocks zone. Known as the ‘therapeutic window’, it is the dose high enough to work but not too high to cause side effects and toxicity. The therapeutic window of Aspirin, for example, is between 75 mg and 325 mg. Less than 75 mg will not work - greater than 325 mg will result in too many side effects. A medication without a dose is like a shoe without a size, or a pair of glasses without a prescription - useless.
A medication without a dose is like a shoe without a size, or a pair of glasses without a prescription - useless.
To make things worse, even when the dose of a specific ingredient is listed on the label of a supplement, it still does not guarantee its presence. This has been confirmed in several University-based supplement screening programs. Researchers went to GNC, Whole Foods, Walgreens etc. and randomly selected supplements from the shelves. Fifty percent of the supplements did not contain a single item listed on the label. With hundreds of millions of Americans using supplements it appears that we are living in an age of “the mass consumption of fillers”.
Fifty percent of the supplements did not contain a single item listed on the label.
The prescriber
Notwithstanding the unknown dosage and quality of the product, the chiropractor was basically prescribing my healthy patient a daily aspirin. Before doing so, the following steps should have been taken:
Search for evidence that the benefits of daily Aspirin outweigh harms in a healthy patient.
Warn about possible side effects including death from massive GI bleeding.
Inquire about a history of stomach ulcer or gastritis.
Inquire about a history of kidney or liver problems.
Draw blood to check kidney and liver function.
Inquire about a personal or family history of bleeding.
Ask about NSAID allergies.
Determine if there is an interaction with other medications or supplements.
My patient admitted that none of these steps were taken or information disclosed. This is not surprising; chiropractors receive no formal training in: Evidence-based Medicine, Pharmacology, Physiology, Nephrology, Gastroenterology or Hematology.
The Supplement Double Standard
I proposed to my patient the following scenario. I, his Internist, will prescribe him six medications. I claim the medications will help with “exercise recovery, support his joints, and improve his overall vitality”. I sell the prescriptions directly out of my office for profit. What would happen?
Once at home, he read would look up the prescription medications and find hundreds of side effects and interactions with other medications. He would probably call me up and say, “Dr. Woolf, I am generally a healthy guy; are you sure about this?”. He would ask me to refrain from using vague language like “support” and “vitality”, and expect a more specific rationale for prescribing each of the six medications. What’s more, he would be suspicious of a financial conflict of interest when his Internist is directly profiting from the sale of medications.
All of the above would be appropriate responses to an Internist trying to sell six medications to a healthy patient. However, when an incompetent prescriber tries to sell my patient a supplement with six ingredients of dubious quality and dosage, he can’t find a bottle of water quick enough to get the first pill down - no questions asked. This is the supplement double standard - supplements are perceived as having all the benefits of medicines with none of the side effects.