As a vaccine supporter, I get accused of being a shill for Big Pharma all the time. My basement is filled with gold bars shipped to me in remuneration for my services to the corporate hooligans – wait. No basement, no gold bars. On the other hand, Big Supplement, those companies who make money off of people who think that if they take this one vitamin to prevent all cancer, makes a a ton of money selling this junk medicine to unwary and unsophisticated consumers.
Let’s take a moment and look at the differences between Big Pharma and Big Supplement. The former has to work hard and provide evidence of what its drugs do, while the latter basically can sit around and throw darts at various claims, then randomly assign those claims to some new or old supplement.
Regulation of Big Supplement
Most importantly, and I don’t think this is stressed enough, Big Supplement gets to make its boatloads of money without the research and development investment along with the regulatory hurdles that make it challenging to get real pharmaceutical products to the market. As opposed to the myth that whatever Big Pharma wants, Big Pharma gets, the actual reality of drug development is that most drugs that enter clinical trials are a complete failure. In fact, around 10% of drugs that enter these pivotal studies ever get approved by the FDA. That’s a 90% failure rate, which establishes the tremendous value of the clinical trial system that we have today – it weeds out most of the useless medicine. A typical drug company spends 10-20% of its revenue on research and development. For larger pharmaceutical companies, that ends up being billions of dollars every year.
Big Supplement, on the other hand, gets to make it’s claims without much scientific evidence, certainly there is almost no requirement for randomized double-blind clinical trials to support its specious claims. The FDA does regulate the manufacturing and purity of these supplements, but otherwise Big Supplement can make whatever claim it wants about its products.
This arose as a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA) which allows supplement manufacturers to sell dietary supplements, that were marketed in the United States before 1994, without any FDA review of the effectiveness of these supplements. Often, the supplement manufacturer will make some bold claim, like “take vitamin XYZ, and you’ll lose weight” – however, in tiny print somewhere, Big Supplement will say “these claims have not been evaluated by the FDA.” No kidding. At least that caveat was accurate.
Just to be clear, the FDA still regulates the supplement industry in many ways. They have to actually produce a supplement that has the ingredients which they claim is in the product. If the supplement causes a safety problem, which is fairly common, the FDA can step in and shut down sales of that product. Also, if a product contains a dangerous ingredient that acts like a drug, then they can get involved and, again, pull the supplement off the market. However, if Big Supplement sells vitamin XYZ for weight loss, and it meets the purity and safety standards of the FDA, then they can continue to sell that vitamin XYZ for weight loss. Or whatever else they want.
Unfortunately, Big Supplement has used the giant loopholes of the DSHEA to create a massive industry that in many respects rivals the value of Big Pharma. As Steven Novella wrote in the Skeptical Inquirer,
The deal that DSHEA…made with the public was this: Let the supplement industry have free reign to market untested products with unsupported claims, and then we’ll fund reliable studies to arm the public with scientific information so they can make good decisions for themselves. This “experiment” (really just a gift to the supplement industry) has been a dismal failure. The result has been an explosion of the supplement industry flooding the marketplace with useless products and false claims.
Furthermore, David Kessler, former commissioner of the FDA, who was in charge when DSHEA was approved, has not been a fan of the DSHEA. His viewpoint about the lack of control over Big Supplement are important to note:
The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a ‘significant and unreasonable risk’ under the conditions of use on the label or as commonly consumed…Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be.
Basically, Big Supplement has a license to print money without the numerous limitations placed on Big Pharma, which actually has to show the FDA that, according to well designed clinical trials, the products works, and sometimes that the drug works better than what’s on the market currently. The supplement industry has to show none of that. They don’t have to show that the supplement can do what is claimed. They don’t have to show any contraindications. They don’t have to list out 2 pages of potential adverse events. And they don’t have to establish whether the supplement is safe with other real pharmaceuticals.
Big Supplement profits
There is a myth that supplements only come from small producers who, being altruistic, probably make no profit on what they sell. Nothing could be further from the truth. The supplement industry revenue is estimated to have reached US$132.8 billion in 2016 and is expected to reach US$220.3 billion in 2022. According to financial experts researching the supplement industry, it is anticipated to grow at a compound annual growth rate (CAGR) of 8.8% between 2017 and 2022.
To be fair, Big Supplement is less than 20% of the size of the global pharmaceutical industry, which is estimated to be around US$1,120 billion in 2022. However, the supplement industry’s CAGR is about 30% faster than the pharmaceutical industry, so eventually Big Supplement will be almost the size of Big Pharma. And because of the growth rates in the supplement world, many legitimate pharmaceutical companies own subsidiaries that manufacture supplements for sale at your local GNC store. How’s that for irony?
And back to that R&D effort. In 2022, it is estimated that the pharmaceutical industry, as a whole, will spend over US$182 billion in research and development, about the size of the supplement industry itself. Let’s look at one of the largest supplement manufacturers in the USA, Herbalife, which had US$4.48 billion in revenue in 2016. They spent precisely 0% of their revenue on R&D, compared to the estimated 18% of revenue that the pharmaceutical industry will spend on R&D in 2022. I poured through their financial filings, and I was unable to find any mention of significant efforts in R&D. I guess their R&D consists of mixing blueberries and kale, and claiming it protects against cancer. All cancer.
Of course, someone might point out that Herbalife just does some funky thing with its accounting of R&D expenses. But I found the same with other companies considered part of Big Supplement like Nu Skin and Integrated Bio-Pharma. No R&D. Why would they account for it if there’s really no requirement for it to put product on the market. Put some vitamin D into a capsule and make all kinds of specious claims. They’re safe, and they don’t have to show a word of evidence in support of their claims.
The pseudoscience of supplements
There really is no robust evidence that supports the use of any supplement. For example, a vitamin D deficiency is a fairly serious concern for your overall health, so sure, if you have that deficiency, you should take a vitamin D supplement. But this deficiency can be easily diagnosed through a simple blood test, and a physician can prescribe the right amount of vitamin D to get your blood levels normal. And more vitamin D is not going to make you healthier in some magical way. Just having a normal blood level is sufficient. But in fact, you can maintain a healthy level of vitamin D through a balanced diet of common foods that have high vitamin D levels.
Beyond keeping normal levels of the micronutrient, excess vitamin D has no effect on the risk of cancer or heart disease. In fact, there is little evidence that any vitamin, beyond what is required to maintain a normal healthy level, has any additional effect on cancer. On the other hand, there really are only a handful of methods that reduce risk of cancer, and none of them include any supplement whatsoever.
Here are a list of supplements that don’t work for anything:
- Echinacea – no, it doesn’t do anything for a cold.
- Vitamin C – no, it doesn’t help with a cold.
- Oscillococcinum – no, it doesn’t treat the flu.
- Omega 3 oil – no, it does not prevent heart disease.
I could go on and on regarding popular supplements and their lack of efficacy in treating any disease claimed by the manufacturer of said supplement. But of course, since they don’t have to provide evidence of efficacy, it’s pretty difficult to find anything that supports the use of these supplements published in real peer-reviewed journals. Occasionally, a supplement may work for a specific issue. I mean it’s clear we need vitamin C to prevent scurvy. That’s been known for years, but I wonder how often scurvy cases are seen by your average pediatrician per year.
However, then the problem becomes much worse when examining supplements – what dosage is good and what is not? What formulation makes the supplement more or less effective? What are the supplement’s interactions with other medications – does it hurt the efficacy of the other medication? What are the known adverse effects of the supplements? What are the potential serious contraindications? Real medicine with real evidence has to show all of that and more.
A lot of pseudoscience of supplements are based on anecdotes, which, as we know, are not scientific data, appeals to antiquity, and a number of other myths. It’s rarely based on real scientific research in the form of the gold standard of pharmaceutical research – the double blind clinical trial.
How many times have you heard someone say, “vaccines are bad, it just lines the pockets of Big Pharma. Just take echinacea, vitamin D, and this blueberry-kale extract – it will protect you from cancer.” Here’s the thing, Big Pharma has to invest billions of dollars to develop vaccines, then to test that they are safe and effective. That’s an expensive undertaking.
Big Supplement is making boatloads of money, and it just has to say it out loud, that their supplements protect you from whatever disease. They never have to show that it really does so, because no one makes them provide evidence of their claims. They never have to test their supplements for anything but purity. But they can make their profits, growing at a faster rate than pharmaceuticals.
The problem with the supplement industry is if they were held to the standards of pharmaceuticals is that they can no longer be sold at your local GNC, but only through a licensed pharmacy. Who knows, maybe some of these supplements have a positive, testable effect on human health. But that would make them “medicine” with all of the costs, regulations, and standards that apply to any real medicine.
With all the issues that supplements have, I think Big Supplement prefers the current system, with nearly untapped potential of huge profits. Of course.
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