By Todd Harrison, Venable11.09.20
To understate the matter, 2020 has been one of the most interesting years I have experienced in my close to six decades on this planet. As of this writing, we are 9 months into the COVID-19 pandemic. While some states have opened up more than others, many of us continue to work from home, with one day bleeding into another. We rely on Zoom, Go to Meeting, Skype, and similar apps to do video calls so we can feel connected with each other.
This of course has an impact, as people attempt to find ways to deal with the pandemic and the toll it’s taking on our collective soul. We consume news and research and try to determine whether new therapeutics are helpful or not. We wonder who to trust about vaccines, and how many people will eventually take them when approved for mass distribution.
All in all, we play with life itself in double-blind, placebo-controlled studies by giving certain people a placebo and others the active ingredients. Conventional scientists continue to play God, treating those in power with passionate-use-exception drugs that were reserved for the sickest of patients.
President Trump’s recovery seemed remarkably quick, but very few people are given these experimental medications within 72 hours of symptom onset. And if we’ve learned anything about the use of anti-viral drugs, administration within that time frame seems to offer the maximum benefit.
Yet, we still only conduct studies on the sickest patients. Maybe if we granted access to these drugs upon onset, then the death toll would be significantly less; but maybe not. This illustrates the problem with modern medicine today. We are wedded to an approach that lacks common sense; we search for an ultimate truth while ignoring what can be seen plainly. Anti-virals should be given at onset, not at the brink of death.
Health Status Makes A Difference
However, there is a greater travesty that is largely ignored. Overall health status is directly correlated to COVID-19 outcomes. However, modern medicine ignores that fact because it is difficult to assess the benefits of health status in double-blind, placebo-controlled studies. Associations, correlations, and epidemiology studies get ignored by modern medicine. People who advocate a common-sense approach are considered quacks and shouted down.
We as an industry, however, need to start speaking up more loudly. Enough is enough. Health status matters in this public health crisis. We already had pandemics of diabetes, heart disease, cancer, and similar fundamental health problems. Health matters whether you are fighting a respiratory infection or a chronic disease.
Our current crisis requires a holistic approach that can’t be tracked easily through randomized, double-blind, placebo-controlled clinical studies. Health requires eating a balanced diet, moderate alcohol intake, exercise, and finally, appropriate supplementation. Yes, supplementation does help improve individual health status, and we need to tell the naysayers inside government and public health institutions that their approach has utterly failed.
Communities have grown sicker because too many people fail to claim nutritional status matters. On the flip side, there are too many hucksters out there who want to sell dietary supplements as a silver bullet: “Do whatever you want, but take this supplement and you can counteract the effects of living an unhealthy lifestyle.”
I have no doubt that vitamin D is an important nutrient, but if people taking supplements continue to lead unhealthy lifestyles and consume processed foods with no nutritional value, then they probably won’t see much benefit in reducing the risk of heart disease, cancer, or diabetes.
Appropriate, effective, and targeted supplementation will be key. This will mean not only educating doctors about the role nutrition plays in health, but the general public as well. It will mean improving access to affordable foods that have not been stripped of their nutritional value due to large-scale farming. It will also mean, importantly, giving the public access to helpful information regarding dietary supplements, and promotion of common sense.
This brings me back to vitamin D and the pandemic still before us, 9 months and counting. I am not going to get enough vitamin D by sitting in my house, staring at a computer or my front yard. (I am growing weary of looking at my front yard, though I am thankful for it). I feel despair as politicians play games with our lives—and they all do it. They tell us to follow the science when the science is not well-understood or ignores the obvious: good health always matters when facing a disease.
This despair becomes greater as vitamin D levels plummet. Common sense tells us this to be true, even though it gets ignored because we don’t have a double-blind, placebo-controlled study to prove this hypothesis. Common sense tells us that if we educate people about the benefits of vitamin D, they would actually take this relatively cheap vitamin. We know people are deficient in vitamin D. How many lives could have been saved during this pandemic if we had applied common sense years ago and improved the public’s vitamin D status?
As the epidemiological evidence comes in, we see at a minimum, there appears to be an association between vitamin D status and COVID-19 outcomes. But if a company said that on its website, it would risk drawing the ire of FDA and FTC, who instead of using common sense attempt to suppress truthful speech.
Tools in the War Chest
Vitamin D is not a panacea, no more than social distancing or wearing a mask is a panacea. Rather, these measures are tools in our war chest to reduce the risk of COVID-19 spread. Similarly, vitamin D should be a tool in that war chest to fight this disease, along with zinc. But the U.S. government is doing nothing to inform the public that taking these two nutrients is important to immune system function, or that they could reduce the risk of developing a more severe case of COVID-19. If we considered nutrition as a tool in our arsenal, maybe we could actually move the needle.
With that said, industry is considering a clinical trial with vitamin D. However, the design fails to account for proper dosing. The proposed 3,000 IU and 300 IU per day is likely setting this trial up for failure. The key is to increase the level of vitamin D to optimal levels; and 3,000 IU may not move the needle at all. Any study should be designed to increase levels quickly and safely. While 3,000 IU may help someone whose vitamin D is slightly less than optimal, it may not help a person who is substantially deficient.
The initial dosing may need to be more like 10,000 IU, or potentially even higher. Of course, this is the problem with studying dietary ingredients; we don’t know what the optimal dose may be.
I applaud the industry for wanting to do this study, but its proposed design may lead to failure, and another news report that supplements don’t make a difference, which would reinforce the modern medicine narrative that nutrient status is irrelevant to health. And by the way, here’s a drug that brings a hammer to the situation with all its potential side effects.
Let me make this clear. I am not anti-vaccine. If one is approved I will take it, as long as it has a good safety profile, because I want to get back to my office and stop staring at my front yard. However, I will also continue to take vitamin D, zinc, beta-glucan, NAC, and quercetin. I will continue to watch what I eat and exercise, because all these approaches are necessary to protect my health. And there is reasonable information for all of these approaches when dealing with a respiratory infection, even if the government won’t tell people that.
How do I know this without double-blind, placebo-controlled studies? Because common sense tells me it’s true. This doesn’t mean I won’t get COVID-19, the flu, or another serious disease, but it will reduce my risk along with exercising reasonable cautions, such as wearing a mask in public, washing my hands, and social distancing. It is a tool in our arsenal and we should be telling our political and scientific leaders that it’s past time to inform people that nutritional approaches may very well help reduce the risk of infection, or disease progression itself.
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
This of course has an impact, as people attempt to find ways to deal with the pandemic and the toll it’s taking on our collective soul. We consume news and research and try to determine whether new therapeutics are helpful or not. We wonder who to trust about vaccines, and how many people will eventually take them when approved for mass distribution.
All in all, we play with life itself in double-blind, placebo-controlled studies by giving certain people a placebo and others the active ingredients. Conventional scientists continue to play God, treating those in power with passionate-use-exception drugs that were reserved for the sickest of patients.
President Trump’s recovery seemed remarkably quick, but very few people are given these experimental medications within 72 hours of symptom onset. And if we’ve learned anything about the use of anti-viral drugs, administration within that time frame seems to offer the maximum benefit.
Yet, we still only conduct studies on the sickest patients. Maybe if we granted access to these drugs upon onset, then the death toll would be significantly less; but maybe not. This illustrates the problem with modern medicine today. We are wedded to an approach that lacks common sense; we search for an ultimate truth while ignoring what can be seen plainly. Anti-virals should be given at onset, not at the brink of death.
Health Status Makes A Difference
However, there is a greater travesty that is largely ignored. Overall health status is directly correlated to COVID-19 outcomes. However, modern medicine ignores that fact because it is difficult to assess the benefits of health status in double-blind, placebo-controlled studies. Associations, correlations, and epidemiology studies get ignored by modern medicine. People who advocate a common-sense approach are considered quacks and shouted down.
We as an industry, however, need to start speaking up more loudly. Enough is enough. Health status matters in this public health crisis. We already had pandemics of diabetes, heart disease, cancer, and similar fundamental health problems. Health matters whether you are fighting a respiratory infection or a chronic disease.
Our current crisis requires a holistic approach that can’t be tracked easily through randomized, double-blind, placebo-controlled clinical studies. Health requires eating a balanced diet, moderate alcohol intake, exercise, and finally, appropriate supplementation. Yes, supplementation does help improve individual health status, and we need to tell the naysayers inside government and public health institutions that their approach has utterly failed.
Communities have grown sicker because too many people fail to claim nutritional status matters. On the flip side, there are too many hucksters out there who want to sell dietary supplements as a silver bullet: “Do whatever you want, but take this supplement and you can counteract the effects of living an unhealthy lifestyle.”
I have no doubt that vitamin D is an important nutrient, but if people taking supplements continue to lead unhealthy lifestyles and consume processed foods with no nutritional value, then they probably won’t see much benefit in reducing the risk of heart disease, cancer, or diabetes.
Appropriate, effective, and targeted supplementation will be key. This will mean not only educating doctors about the role nutrition plays in health, but the general public as well. It will mean improving access to affordable foods that have not been stripped of their nutritional value due to large-scale farming. It will also mean, importantly, giving the public access to helpful information regarding dietary supplements, and promotion of common sense.
This brings me back to vitamin D and the pandemic still before us, 9 months and counting. I am not going to get enough vitamin D by sitting in my house, staring at a computer or my front yard. (I am growing weary of looking at my front yard, though I am thankful for it). I feel despair as politicians play games with our lives—and they all do it. They tell us to follow the science when the science is not well-understood or ignores the obvious: good health always matters when facing a disease.
This despair becomes greater as vitamin D levels plummet. Common sense tells us this to be true, even though it gets ignored because we don’t have a double-blind, placebo-controlled study to prove this hypothesis. Common sense tells us that if we educate people about the benefits of vitamin D, they would actually take this relatively cheap vitamin. We know people are deficient in vitamin D. How many lives could have been saved during this pandemic if we had applied common sense years ago and improved the public’s vitamin D status?
As the epidemiological evidence comes in, we see at a minimum, there appears to be an association between vitamin D status and COVID-19 outcomes. But if a company said that on its website, it would risk drawing the ire of FDA and FTC, who instead of using common sense attempt to suppress truthful speech.
Tools in the War Chest
Vitamin D is not a panacea, no more than social distancing or wearing a mask is a panacea. Rather, these measures are tools in our war chest to reduce the risk of COVID-19 spread. Similarly, vitamin D should be a tool in that war chest to fight this disease, along with zinc. But the U.S. government is doing nothing to inform the public that taking these two nutrients is important to immune system function, or that they could reduce the risk of developing a more severe case of COVID-19. If we considered nutrition as a tool in our arsenal, maybe we could actually move the needle.
With that said, industry is considering a clinical trial with vitamin D. However, the design fails to account for proper dosing. The proposed 3,000 IU and 300 IU per day is likely setting this trial up for failure. The key is to increase the level of vitamin D to optimal levels; and 3,000 IU may not move the needle at all. Any study should be designed to increase levels quickly and safely. While 3,000 IU may help someone whose vitamin D is slightly less than optimal, it may not help a person who is substantially deficient.
The initial dosing may need to be more like 10,000 IU, or potentially even higher. Of course, this is the problem with studying dietary ingredients; we don’t know what the optimal dose may be.
I applaud the industry for wanting to do this study, but its proposed design may lead to failure, and another news report that supplements don’t make a difference, which would reinforce the modern medicine narrative that nutrient status is irrelevant to health. And by the way, here’s a drug that brings a hammer to the situation with all its potential side effects.
Let me make this clear. I am not anti-vaccine. If one is approved I will take it, as long as it has a good safety profile, because I want to get back to my office and stop staring at my front yard. However, I will also continue to take vitamin D, zinc, beta-glucan, NAC, and quercetin. I will continue to watch what I eat and exercise, because all these approaches are necessary to protect my health. And there is reasonable information for all of these approaches when dealing with a respiratory infection, even if the government won’t tell people that.
How do I know this without double-blind, placebo-controlled studies? Because common sense tells me it’s true. This doesn’t mean I won’t get COVID-19, the flu, or another serious disease, but it will reduce my risk along with exercising reasonable cautions, such as wearing a mask in public, washing my hands, and social distancing. It is a tool in our arsenal and we should be telling our political and scientific leaders that it’s past time to inform people that nutritional approaches may very well help reduce the risk of infection, or disease progression itself.
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
