[ed. note: Michael Jorrin, who I dubbed “Doc Gumshoe” years ago, is a longtime medical writer (not a doctor) who writes for us a couple times a month about health issues, marketing, and trends. He does not typically focus on specific investment opportunities, but has agreed to our trading restrictions… as with all of our authors, he chooses his own topics and his words and opinions are his alone]
When I was a little kid, back in the dawn of time, I was given a daily dose of cod liver oil. In those days, my cod liver oil dose was administered by my mother in the form of a large spoonful of a rather nasty tasting liquid. I would then get a few swallows of orange juice to get the disagreeable taste out of my mouth. By the time my little sister came along, the cod liver oil came in the form of pretty little gelatin pills, which went down my sister’s gullet with relative ease.
What was the cod liver oil supposed to do for us? Currently, the best-known benefit of cod liver oil (which just about everybody referred to as CLO) is that, along with other fish oils, it is a good source of omega-3 fatty acids. But when my sister and I were given CLO it was because it was known to be an excellent source of Vitamin D and thus prevented rickets, a disease of nutritional deficiency, which causes weak bones and frequently bow-leggedness. Infants who are exclusively breast-fed are thought to be particularly susceptible to rickets, a disease caused by Vitamin D deficiency, and Vitamin D supplementation is currently recommended until they get switched to Vitamin D-fortified milk. I kept getting the CLO until I was 8 years old or so, perhaps because our physician recommended it, or perhaps because my mother was extra cautious.
Why did I start out with CLO? Because that yucky stuff precisely meets the definition of a dietary supplement. We ourselves make Vitamin D, but we need abundant exposure to sunlight to do so, and most of us don’t get anywhere near the amount of sun exposure we need to keep our Vitamin D levels optimal. (Exposing our skin to sufficient sunlight might mean risking skin cancer in the summer and frostbite in the winter.) Therefore, we need or at least benefit from Vitamin D supplements.
Another dietary supplement that specifically guards against diseases is Vitamin B1 (thiamin), which protects us against beriberi. This disease particularly affects populations whose diet is based on polished white rice, with the outer coating of the grain removed. It can be prevented by eating unpolished rice, or supplementing the diet with rice bran, which contains thiamin – or, of course, by taking Vitamin B1 pills. Beriberi causes a range of symptoms – neurologic, cardiac, respiratory, muscular, and digestive.
And pellagra, which was endemic in the southern part of the United States as well as many other parts of the world, is caused by a lack of Vitamin B3 (niacin) in the diets of populations whose principal food is corn. In regions in South America where corn is traditionally treated with a strong alkali prior to being ground into grain, pellagra is much less common, because that treatment, called “nixtamalization” makes the niacin in the corn nutritionally available. (“Nixtamalization,” by the way, is composed of two Nahuatl words meaning “ashes,” the source of the alkali used to treat the corn, and – you guessed it! – “tamal,” which, as we know, is a dough made from dried corn that has been treated to remove the tough outer skin.) But as corn cultivation spread to other regions where this was not practiced, pellagra became a fairly common blight. This disease also causes a number of symptoms, usually summarized as diarrhea, dermatitis, dementia, and ultimately death. In the first half of the 20th century, there were three million cases of pellagra in the US, and about 100,000 deaths. Today it is very rare in the US and steeply declining elsewhere.
Vitamins are the quintessential nutritional supplements. By definition, they are present in our food, or, more to our point, they are supposed to be present in our food. And they are essential to our physiologic function. Vitamin deficiencies are responsible for a great range of serious and sometimes fatal health problems, and if they are absent from our diets, we can remedy this quite directly by supplementation. For example, folate (Vitamin B9) is necessary for red blood cell formation and is particularly important in pregnancy. Pregnant women are counseled to make sure their diets are a good source of folate by eating abundant amounts of green leafy vegetables, plus peas, beans, nuts, and a variety of fruit. A dire birth defect, Spina bifida, may affect their babies due to a folate shortage. And in addition to a folate-rich diet, they may be advised to take folic acid as a supplement.
So this much is obvious: if essential vitamins are absent from our diet, we need to supplement our diet with sources of those vitamins in order to ward off those health issues. Those nutritional supplements may be vital to our health.
But what about drugs?
At the other end of the spectrum are substances that we call “medicines” or “drugs.” What distinguishes these from nutritional supplements? For one thing, they aren’t meant to compensate for deficiencies in our diets, so we don’t call them “supplements.” For another, we mostly don’t need them except when we are actually experiencing a disease or health issue of some kind.
Drugs are drugs largely by definition. They are characterized as drugs through having complied with certain legal requirements, which may be different in different nations, but whose common characteristic is that the substance in question, in order to qualify as a drug, needs to openly demonstrate a certain degree of efficacy in treating a medical condition, and also to demonstrate that the benefits provided by treatment with this substance clearly outweigh the risks that this substance will result in harm to the person undergoing the treatment. The data that leads to those conclusions needs to be open to public scrutiny. What this means in the United States is that pharmaceutical companies, in applying for approval from the Food and Drug Administration, must hand over the complete documentation of all the clinical trials that they cite in support of the candidate drug. (I have worked on New Drug Applications (NDA), and the amount of data that gets incorporated in NDAs can run to tens of thousands of pages.) The key relevant data from the clinical trials are condensed and made public in the form of the drug’s prescribing information (PI), which is available to anyone.
… and what about the supplements that would like to be drugs?
In between the substances that are clearly nutritional supplements and those that have met the standard for drugs is a large and very poorly defined agglomeration of substances and preparations, some of which continue to go under the name “supplements,” even though they are clearly not supplements. Another term that has been floated is “neutraceuticals.” A huge range of stuff falls into this undefined category. I do not have another suggestion for a name, so we’ll continue to refer to them as supplements, for want of a better term. They fall under the category of “Complementary and Alternative Medicine,” sometimes abbreviated as CAM.
The cohort that has opted to take sides in the battle between drugs and supplements, which to my mind is utterly unnecessary, has chosen to march under various banners. One banner characterizes drugs as entirely artificial chemicals and therefore essentially unsuited for human consumption, whereas supplements are entirely natural or at least derived from natural substances, and therefore healthful. But the “artificial” versus “natural” dichotomy is phony, as is the notion that “artificial” means that it’s bad for you, while “natural” means that it’s good for you. What’s more “natural” than Amanita phalloides (the death cap mushroom) or rattlesnake toxin?
A great many antibiotics originate in naturally-occurring substances, such as molds. As a Doc Gumshoe reader pointed out, the paclitaxel class of cancer drugs originated in the Pacific Yew tree. Since we don’t want to treat infections with molds, and there aren’t enough Pacific Yew trees to treat all the cancer patients, chemists have duplicated those molecules in the lab, and pharmaceutical companies manufacture them. But both the originals in nature and their “artificial” duplicates are chemicals.
It is certainly the case that drugs are chemicals. They may be simple molecules or highly complex molecules, but they are molecules just the same. All nature consists of atoms and molecules, including every bit of our own bodies. Nature has the capacity of constructing molecules of incredible complexity. It is not easy to draw a clear line between the most complex molecules and the simplest forms of life.
But supplements are also inescapably molecules. This goes for the Vitamin D in cod liver oil and for all the other vitamins, as well as for all the supplements on all the shelves of all the naturopathic shops on the planet. That does not make them any less natural.
The frequent proclamation that supplements cannot be advertised as drugs – i.e., agents that are effective in treating medical conditions – because “natural” substances cannot be patented and therefore pharmaceutical companies will not spend the admittedly colossal amounts of money going through the clinical trials needed to gain regulatory approval, is mostly false, although that position does have a bit of validity. I discussed that issue at considerable length in the Doc Gumshoe piece called “The Regulatory Maze: What It Means for Our Health,” which posted on December 19th, 2017. In a nutshell, it’s true that the original natural substance may not be patentable, but pharmaceutical companies have been isolating the active ingredients in these substances for more than a century and patenting those, as well as the methods of extracting the active ingredients. And by doing so, they have developed hugely successful drugs. As I have repeatedly said, the pharmas keep a sharp eye on all these natural cures and are waiting to pounce.
Looking beyond the exaggerated claims for these supplements …
The question before us is, might some of these have merit? And in trying to answer that question, on what might base our answer?
A common, almost universal characteristic of the promotions for supplements is that they are bolstered by a great number of convincing-so