As we speculate on the many options of institutions to respond to the Institute of Medicine report on vitamin D, the most important is how the NIH and its various departments respond. Driving the response most likely will be the Dietary Supplement and Health Education Act of 1994. This act does several things, but the most important is to limit the authority on dietary supplements by the FDA. As long as a dietary supplement makes no claims about healing or preventing disease, then preapproval for sale by the FDA is not required. So is vitamin D a nutrient or a drug. The DSHEA states that anything shown to prevent or cure disease most be defined as a drug and regulated as such. This is where the language on vitamin and nutrient labels gets tricky. You can suggest that the nutrient may help your body to heal, but you cannot state outright that the nutrient will cause you to heal or prevent a disease.
I really think that Dr. Robert P. Heaney, MD had this in mind when he did the presentation on the physiological action of vitamin D. The title is “Vitamin D: Nutrient, not a Drug.” But by definition according to DSHEA, vitamin D does prevent and treat disease, therefore is a drug. You can watch the presentation through Grass Roots Health and UCSD tv. Dr. Heaney makes the argument that vitamin D does not heal disease. The vitamin D allows the body to respond with its natural healing processes or innate immunity. Vitamin D does this by opening the DNA library that is contained in every cell. This was confirmed in August this year by a report from Oxford University saying that there are over 2700 genes or more than ten percent of the genome with vitamin D pathways.
There is a mountain of research that shows that vitamin D does cure and prevent disease. The only reason that the FDA may not be able to step in and regulate this nutrient as a drug is because of the history of this nutrient and the general safety that has been shown through the use of cod liver oil over many decades. Of course the drug manufacturers will not like the fact that they could have large market losses because of the reduced amount of disease. The other issue of course that must be considered by government is the impact on the economy with a healthy population.
I know the statement above may be counter intuitive when thinking about health and the economy. However, the largest segment of our economy is the health segment. If disease were reduced by twenty five percent then most likely the health segment of the economy would be reduced accordingly. With the present state of the economy in general this could be disastrous. You will not get to decide if you would rather be healthy or have a healthy economy. The government or more specifically, Secretary Kathleen Sebelius of Health and Human Services will decide this for you. I suspect through the guidance of the President since she reports directly to him. Is there any evidence that the government considers the economy more important than your health? Yes the predecessor of Sebelius was Michael Leavitt and his number four principle was ‘markets before mandates’. His last principle of nine was to ‘value life.’
With the economy more important than mandated health, I suspect that there will be an attempt to limit the understanding of vitamin D for the general population. However, there may be significant guilt because of the length of time that this information has already been suppressed. Or if you prefer, the understanding of vitamin D has been ignored. Saying that it has been ignored is a much nicer way to say that we have maintained a medical economy of trillions of dollars from your bad health over the last fifty years. In other words, you had jobs, but your health could have been much better – a true conundrum! Mandate serum testing of the entire population or let them remain in a much worse disease state to maintain the medical economy. I’m glad that is not my decision. You can make your own personal decision about maintaining your vitamin D at a summertime level all year. – Pandemic Survivor
In email communications with Heather Breiner, information contact for the FNB on vitamin D, the most likely release date for the report on vitamin D and calcium is November 30, 2010. I am sure that many institutions are prepared to react to whatever the report suggest. It is almost a certainty that daily required intakes will be increased. However, there are some reactions that would definitely benefit the economy and not the health of the individual. We need plain language to better understand what can happen.
Over the last fifty years there have been two major concerns associated with vitamin D. Both of these concerns kept the general population from getting an adequate amount. First there was the issue of toxicity. I remember when I told my doctor that I was going to supplement with enough vitamin D so that I would have the same serum level that you would maintain in the summertime. He was startled at the 8,000 IU per day that I was suggesting and said that he thought my organs ‘would turn to stone’. This biblical warning really scared me, but I felt that my reading of the peer reviewed medical journal articles was enough assurance that I was on sound footing. This same conversation will happen billions of times around the world over the next years. No large institution will be willing to admit to being so wrong for so long without extreme fear of legal action. There have really been no major incidences of vitamin D toxicity. The issue of death from acetaminophen toxicity with the associated liver failures is the major concern of any substance available for general use of the population. Of course the use of acetaminophen would not be so large if everyone had enough vitamin D which would significantly reduce chronic pain.
In my reading of the literature and comments of toxicity by the researchers on D, the major bad actor has been vitamin D2, the most prescribed form of vitamin D by the medical practitioners. Vitamin D2 is made from the sterols of fungus that is irradiated. Why do they prescribe D2 and not D3? You cannot patent D3. In medical practice D3 and D2 have always been considered as equal in there action in the body. This is somewhat true at very low levels required to prevent and to heal rickets. However, at higher levels of D2 because of the thousands of genetic pathways for vitamin D, D2 causes serious issues and leads to failure of many systems. This has been the major issue of toxicity over the years. Doctors have seen the bad results of D2 and associated all vitamin D with toxicity.
The use of the steroid form of vitamin D has caused misinterpretation that all vitamin D is toxic as well. In trials where the steroid form was given instead of D3 there usually appears to be issues with too much calcium in the blood. It turns out that the body’s mechanism is to produce a substance that destroys the steroid form at the same time the steroid form is produced to keep it from over acting in the body. Vitamin D should never be supplemented as a nutrient or as a substance to heal disease unless it is vitamin D3. Vitamin D3 is what your body makes in the skin from exposure to the sun.
The second concern that has caused the population to have low levels of vitamin D has been the issue with sun exposure and skin cancer. When using sunscreen, almost all vitamin D production in the skin is stopped. As it turns out, the melanoma rate in the US has increased by a factor of four since the 1960’s and the increased use of sun block. So does sun block cause more skin cancer? We will let the courts decide that if sense can be made of the convoluted research that has been presented to date. There is too much money involved for clear thinking. Some manufacturers of sunscreens have taking action to protect them from extreme liability in fear of the existing class action suit that is presently in the California courts. The manufacturers of sunscreen skated by in the legal actions taken by the FDA and FTC in 2000 with good luck over the ruling by now Chief Justice John Roberts. It seems the real truth in the matter is that the amount of skin cancer caused by too much sun exposure is nothing compared to the deaths that result from all the chronic disease that is created by vitamin D deficiency.
All that the researchers are suggesting is for the population to maintain a serum level as if it was summer all year. How could having summer all year be a bad thing? Only for the medical economy- We will try to address this issue next post.
The Institute of Medicine is a part of the National Academies which places itself as the “advisers to the nation on science, engineering, and medicine.” When Food and Nutrition Boards are established by the IOM, they are to review the latest information available on the study item and give a comprehensive report of the findings. For nutrients, this includes the daily required intake or DRI. Ten years ago the FNB on vitamin D left the DRI, as it had been for years, as the amount required to keep children under one year old from getting rickets. This really does not make sense for adults, but that is what we got. So what can we expect from the November report?
Scenario One: The IOM finds that there is not enough research to make a change to the DRI’s so that the present DRI’s are maintained. This would mean that no doctor would be able to tell you that you should take more than 2000 IU per day without violated standard practices or guidelines. This would also mean that anytime a research project would like to use larger amounts then special permission would have to be obtained. Over a million people in the US alone would continue to die every year from vitamin D deficiency.
Scenario Two: The IOM decides based on the current research that adults should be sure to get 2000 IU per day with a maximum daily intake of no more than 5000 IU. I do not know how they could come to this conclusion based on the science as I have just chosen that number out-of –the air. However, this falls in line with what happened ten years ago. It was a number pulled out of the air for adults. If they did decide to do this the good news would be a significant reduction in chronic disease and 350,000 less deaths per year in the US.
Scenario Three: The IOM finds based on the research that everyone needs a minimum of 75 IU/kg/d to maintain the healthy functions of the body. They then translate this to a DRI of 35 IU/lb/d from all sources. This would be difficult for the average person understand and maintain an intake at this level because of the creation of vitamin D through sun exposure, a very complicated process to estimate the amount created. The DRI would most likely be set at 5000 IU per day for adults in the winter and 2000 IU per day in the summer with a maximum intake of 10,000 IU per day supplemental. The board would then recommend that everyone have their serum 25(OH)D tested once to twice per year to maintain adequate intake for health or the level of people in a sunny country of 54 ng/ml to 90 ng/ml. Of course this would be the ideal.
The response by governments and health institutions would be difficult to determine. You can bet that the various institutions have already decided how they will react depending on the recommendations of the IOM. There are huge changes in health results of the general population to be considered with associated socioeconomic outcomes. One example would be that most medical studies would become invalid as there has typically been no control on vitamin D. We will try to explore the possibility of reactions in the next post.