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The FDA should consider vitamin D as a pharmaceutical agent for COVID - Dec 21, 2020

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While the current COVID pandemic has created serious health challenges, there has been a dramatic increase in research examining the effects of vitamins on COVID infections. Many studies report the positive effects of vitamin D in boosting our immune system and protecting against COVID. Studies and seminars have shown that for those people who do not receive vitamin D from outdoor sun exposure, a daily intake of about 5000 IU of vitamin D3 boosts the immune system and confers significant anti-viral protective effects. The lesson here is that the FDA should re-classify vitamin D as a pharmaceutical agent and review its medical/clinical effects to either approve or disapprove this vitamin as an efficacious agent for COVID 19 as well as for other viral infections.

The process by which the FDA handles dietary supplements is the reverse of the way prescription and non-prescription drugs are handled. Unlike prescriptions, there are no provisions in the law for FDA to “approve” vitamins for safety or effectiveness before they reach the consumer. Once a dietary supplement is marketed, it is the FDA’s responsibility to prove that the product is not safe to restrict its use or remove it from the market. These guidelines were established in 1994, as the Dietary Supplement Health and Education Act (DSHEA). Under these guidelines, manufacturers must not test supplements in clinical trials for health risks or potential interactions with other drugs. The ethical rationale for issuing these guidelines is that many dietary supplements are safe and have few health risks as millions of people take multivitamins. Vitamins may be safe but do they necessarily provide health benefits? The BMJ recently published a short review citing that many clinical studies that find no health benefits from multivitamins in protecting a person from cardiovascular disease, cancer, diabetes, or osteoporosis.

The classification of vitamins, especially vitamin D, as a non-pharmaceuticals can be challenged by the many studies that have emerged from the COVID-19 pandemic. These studies were motivated by the great need to rapidly identify and develop anti-COVID drugs and vaccines to treat the millions of infected COVID people. Many clinical studies have shown that the efficacy of Vitamin D against COVID is, in part,  because vitamin D improves the physical barrier against viruses by maintaining epithelial tight junctions and triggers cellular natural immunity. In one study involving twenty European countries, a negative correlation was found between serum 25 (OH) D levels and the total number of cases with COVID-19 disease and mortality rates due to this disease. Increases in serum 25 (OH) D levels in the COVID-19 patients appears to improve the clinical course or alleviate clinical outcomes, even in severe cases. Not only does vitamin D protect against COVID-19 but it also appears to reduce the risk of developing other viruses such as influenza.

High-dose vitamin D supplementation needs to be assessed in the elderly, obese, dark skin, and those living at higher latitudes. Thirty-five degrees North appears to be the latitude above which people do not receive sufficient sunlight to retain adequate vitamin D levels during winter. With increasing age, the production of vitamin D in the skin and serum concentrations decrease considerably. This may be one of the key factors why the death rate for COVID-19 disease rises with age. Thus, vitamin D supplementation in the winter and for the aged should be recommended. In light of the literature cited above and many other articles, the antiviral and anti-inflammatory efficacy of vitamin D is significant to consider as a pharmaceutical agent that improves the immune system’s ability to fight COVID other viral infections.

Vitamin D supplementation appears to be effective in a variety of diseases besides COVID. For example, in a randomized clinical trial, supplementation with vitamin D reduced advanced (metastatic or fatal) cancer incidence. However, JAMA reported that among older than 70-year-old adults without major comorbidities, vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. In addition, vitamin D supplementation did not prevent severe asthma exacerbations in children or preserve kidney function in patients with type 2 diabetes.

In general, there are no reported serious side effects in people taking 6,000 ID of vitamin D. However, there are reports that aluminum interacts with Vitamin D that may present health problems for people with kidney disease.  In addition, Calcipotriene is a drug that is structurally similar to vitamin D. Taking vitamin D along with calcipotriene (Dovonex) might increase the effects and side effects of calcipotriene (Dovonex).

Given all of the recent clinical studies on the usefulness of this vitamin to mitigate viral infections and other diseases, the FDA should reclassify this dietary supplement as a pharmaceutical agent and issue its recommendations. What are the appropriate medical conditions that warrant vitamin D supplementation? Do the clinical studies support that hypothesis that vitamin D boosts the immune system? Clearly, during this pandemic, the public has great confidence in the FDA, and unlike in past decades, there is also a resurgence in the public’s acceptance of vitamin supplements. According to Bloomberg, the U.S. dietary supplement market will reach 216 billion by 2026, highlighting the growth in public interest in vitamins to improve their health. The 2020 FDA budget is only 6.1 billion, representing a fraction of what the public spends. The public is now embracing vitamin supplementation, and it is ethically appropriate and timely for the FDA to consider vitamin D as a pharmaceutical agent to review the vitamin D clinical studies and issue its recommendations.

John D. Loike is a bioethicist.

See also VitaminDWiki

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Created by admin. Last Modification: Tuesday December 22, 2020 00:15:40 GMT-0000 by admin. (Version 3)