5. Unprovable Effectiveness

The antiviral and anti-inflammatory properties of food are not promoted or researched by the healthcare, pharmaceutical, or nutraceutical industries because there is little profit from promoting whole foods. According to a study done by researchers at Johns Hopkins Center for Drug Safety and Effectiveness and published in the JAMA Internal Medicine, the average cost of FDA approval for a new drug is around $19 million. If drugs already exist to treat the disease, clinical trials are needed to compare the new drug to these current treatments. This process potentially increases the cost to obtain FDA approval to $345 million. As a former pharmaceutical investment analyst, I have witnessed firsthand many drug and biotech companies losing billions of research dollars on failed clinical trials.

Since whole foods are not patentable, no food producer or industry is willing to risk millions of dollars without any guarantee of success to prove whether a food is effective in preventing or treating a disease. If, for some reason, a food producer did have the money to get FDA approval for its food, competitors would be able to benefit from the approval since a naturally occurring whole food is not patentable. Thus, there is no financial incentive for food companies to fund large clinical trials to seek FDA approval. Without FDA approval, food and supplement companies are prohibited from claiming their products are effective in preventing or treating disease. These companies are limited to using general words such as "immune support" or "immune booster" to refer to the antiviral effects of their food or supplement.

Support for whole foods by healthcare providers is also limited because the healthcare industry relies on evidence-based medicine and heavily marketed pharmaceuticals. Healthcare providers will increase their liability if they promote non-FDA approved treatments or unproven alternative treatments over established treatments to their patients. Unfortunately, our healthcare system is not focused on nutrition. According to a 2010 study in Academic Medicine, medical students were taught on the average only 19.6 hours about nutrition. Also, most patients expect a prescription for a magic pill to treat their illness and will be disappointed to be told to eat healthier. Even if a patient is willing to eat healthier, they may be unaware of which foods are most nutritious. And because eating habits are so difficult to change, taking a small pill is a lot easier and more effective in increasing medication compliance.

Government and philanthropic organizations usually fund basic discovery research because this type of early-stage research is cheaper and less risky. A study of the National Institute of Health’s (NIH) funding between 2010-2020 showed that over 90 percent of NIH funding went to research biological targets and not drugs. Most drug research grants to fund late-stage proof of concept or efficacy research are provided by large pharmaceutical companies or venture capital-funded startups. Rarely the government will fully fund large, late-stage clinical studies. One of these large studies that were government-funded was the famous Age-Related Eye Disease Study (AREDS) that studied 4,757 participants and showed the benefits of vitamins and minerals in slowing the progression of age-related macular degeneration, the leading cause of blindness in people over 55. It was funded by the National Eye Institute, one of many institutes of National Institutes of Health operating under the U.S. Department of Health and Human Services. However, the study was partially supported by Bausch & Lomb, which was later awarded the exclusive worldwide patent for the AREDS formulation used in its Ocuvite eye supplement, the leading eye vitamin in the United States. Large clinical trials are expensive and risky for even the U.S. government to take on the financial risk alone.

Without the strong support of the government, philanthropic organizations, or healthcare providers combined with a costly FDA approval process and lack of financial incentive from patent protection, food and supplement companies are at a disadvantage to pharmaceutical companies in proving if a drug works. Food and supplement companies must rely on word of mouth, anecdotal evidence, and results from small or weakly designed clinical trials mostly conducted in foreign countries. Thus, the effectiveness of whole foods to prevent and treat diseases can never be proven, and therefore, can never be claimed to be a treatment or cure.


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These statements made on this website have not been evaluated by the Food and Drug Administration. This website and its products are not intended to diagnose, treat, cure, or prevent any disease. Please consult your physician before implementing any new diet, especially if you have pre-existing medical conditions, taking prescribed medications, pregnant, or nursing. Avoid all foods that you are allergic to. Discontinue using the meal plan and consult your physician if any adverse reactions occur. Not intended for use by persons under the age of 18. The statements made on this website are for educational purposes only and are not meant to replace the advice of your physician or healthcare provider.

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