My Heart Aches — Vitamin D vs. Measles Vaccine

There has been one death from measles since 2003, but how many deaths have there been because of poor nutrition since 2003 or just vitamin D deficiency alone? Relax, kick back, and consider the possibilities as you read.

Life Balance

My heart aches as I think of the thousands that are dying premature deaths. Preventable death, our medical profession says, is worth the money. In fact, many of the life-saving drugs have been only able to extend life by a few months, weeks, and even days, but has the death rate really decreased from chronic disease? Dying people are asked to make the decision. The decision usually is about spending the money in trade for a few days of “quality” life. What if the question was not about the money, but only if you have the proper nutrition. When offering a dying friend or relative nutrition, you get treated by the medical profession as if you are about to perform a criminal act. Your response to this onslaught is that your cared-for-loved one was just thirsty and you wanted to give them a class of water.

We have reached a breaking point in our understanding of life versus what is important for the greater good. Science and technology have moved along. Unfortunately, greed has remained the same in our culture forever. Knowledge of how to save life has been hidden and manipulated for the greater good as determined by our institutions. The population is believed to be too stupid to understand the importance of maintaining an active economy, and a manipulated economy, which has put us in debt for trillions of dollars, almost to the point of failure like Greece. Greed shows up in crafty ways to hide the theft from the people of both life and money.

We don’t want it to be about the money and increase the amount of insurance that we have. We want the security of knowing that whatever disease is stalking us, we have the means to provide the best available. Hidden from us is what is the best available for health and wealth of the individual. Healthcare is always about an expensive new drug, or because it is no longer readily available, even an expensive old drug; always trying to manipulate supply and demand to get the highest margins available. I had a relative that was dying from cancer and it was obvious that he only had a few days or hours at best. He had already started the death rattle as my Dad used to say. The doctor’s response was to offer him a drug that was used regularly in the 1960s, but now was not readily available. The cost of the drug was $50,000 per day. You just can’t make this stuff up. The doctor knew my relative had means and was willing to offer him an imagined time of a few weeks or days of quality life. My relative’s response to this was, “Holy Moly!” Even on his deathbed, he knew he was being scammed.

It is time to take back both our health and financial resources. We have gone too long with the understanding the security of health insurance is more important than our understanding of nutrition. Now it may be hard for you to hold two seemingly unlike things in balance. How can we balance medical/medical insurance industrial complex with nutrition? The interesting thing is our institutions have done that for you because of their belief that you are too stupid to understand. As kept cows, you keep repeating, “Thank you master.” The master treats you with great care while at the same time reaching into your pocket and taking your wallet. Yes, I have just described a mugging. The medical complex gets about half of every dollar you spend on health care and the health insurance complex gets about half. This way, they become equal partners in crime so that one does not rat out the other. Don’t get me wrong. I think we have the best emergency medical system in the world and I’m very grateful for that. If not, I wouldn’t be alive from a ruptured appendix, hypoxia from sleep apnea (which I’ve cured with supplements), two back surgeries to keep me from being paralyzed (I avoided several more with supplements), multiple infections, and two heat strokes.

We recently had the first death from measles in the US since 2003. Think about all of the press you have read about forced measles vaccines and people’s rights to refuse the vaccine. Hold this in opposition to the very inexpensive supplementation of vitamin D. The IOM said 600 IU/d was all that you need in 2010. In November 2014, it was found, when using the same data as the IOM, that they had made a statistical error. The correct amount should have been over 7,000 IU/d as confirmed by three universities. Epidemiologists have said that all we need to stop 37,000 premature deaths in Canada per year is a 25(OH)D level above 40 ng/ml (about 3,000 more IU/d than the present intake from all sources [estimated from grassrootshealth.net chart]) . If we generalize the Canadian deaths for the US population, it is about 400, 000 premature deaths per year for North America.

Where is the press on this issue? How many premature deaths have there been since November 2014 when the error was found? How many premature deaths have there been since 2010 when the error was made? How would all of this affect the health economy since 2010 (generalizing for North America from the above referenced paper, about $150 billion per year or about $750 billion in reduced cost minus the cost of supplementation and two million premature deaths)? Was it really an error? What about the combination of vitamins and minerals? How far off is the recommendation for all supplements and the combination of supplements? My heart aches for those who don’t understand nutrition. My heart aches for the doctors (I really feel for the doctors who are swimming along comfortably as in a school of fish.) who were taught that vitamins and minerals will not cure, prevent, treat, or diagnose disease (On how many supplement bottles have you seen that statement?). Moreover, the US press doesn’t think there is a story here as they worry about one death from measles in the US since 2003 and whether you have been vaccinated.

If you are concerned about this issue, do what I have done – contact your congressional representative. Here is a link to help you find your representative or http://www.house.gov/representatives/find/. Visiting in person is better than a written letter or an email if you would like to take the time. After all, the purpose of the House is to hear the voice of the people. Below is my constituent request. Feel free to print a copy and its links to take to your representative. – Pandemic Survivor

Constituent Request to Representative Mark Walker:
The Department of HHS needs to be investigated by Congress for not quickly responding to the finding that the RDA for vitamin D, as established by the Institute of Medicine (National Academy of Medicine as of July 1), was off by a factor of more than 10. This tragic error may have resulted in as much as hundreds of thousands premature deaths per year and has added a significant burden to the health economy.

  1. J. Veugelers, PhD, Health Canada and the University of Alberta, first reported this error in a published peer reviewed journal paper in November 2014. It was confirmed in a published paper by UCSD and Creighton University in February 2015. To my knowledge, the IOM or HHS or its agencies have taken no action. More details: Dr. Robert Heaney http://blogs.creighton.edu/heaney/2015/02/13/the-iom-miscalculated-its-rda-for-vitamin-d/

The vitamin D market has been manipulated for the profit of the health industry since the 1930s (see attached article for details – Vitamin D for Profits – 1923 to 1946). Fear of the sun has caused a huge decline in health in the US. It is now time to take action to stop the immorality of sustaining and growing the largest segment of the economy from the illness of individuals (see attached Advocacy Letter from Allan Markin ).

Resources
The Vitamin D Council – Dr. John Cannell – www.vitamindcouncil.org
SUNARC: Sunlight, Nutrition, and Health Research Center. Website of vitamin D expert Dr. William Grant  www.sunarc.org
GrassrootsHealth – Carrole Baggerly, Founder, Presentations by over fifty researchers and doctors. http://www.grassrootshealth.net/
University California Riverside – About Vitamin D http://vitamind.ucr.edu/about.html
Vitamin D Wiki – research on vitamin D compiled by Henry Lahore http://www.VitaminDWiki.com

Vitamin D — A Conflict of Science

“Science in the modern world has many uses; its chief use, however, is to provide long words to cover the errors of the rich.” And more – “Truth, of course, must of necessity be stranger than fiction, for we have made fiction to suit ourselves.” – G.K. Chesterton

Chesterton was all about words and expressions of truth. This early 20th Century writer, philosopher, and humorist used words with great skill in debate and general discussions. I am sure he would be appalled at vitamin D science. Has science and allopathic medicine developed into some form of fiction to enhance the rich? Worse, has the largest sector of the US economy been sustained through production off the illness of the population?

Perhaps you should pause and take the time to read this article from Hank Campbell, published in the Wall Street Journal – The Corruption of Peer Review is Harming Scientific Credibility. There have been thousands of peer reviewed published papers on Vitamin D and its benefit to health. And, our greatest bastion of science, National Academy of Science and its Institute of Medicine, has allowed an error for the RDA for vitamin D to escape into the public domain. They were only off by over a factor of ten too low. Is this a mistake like the crash of the Martian Lander that went down because the conversion from miles to kilometers was in error? The only harm was the cost to the taxpayers. Because of a factor of ten for vitamin D intake, hundreds of thousands die prematurely in North America each year. Here is the recently published paper by Paul J. Veugelers, A Statistical Error in the Estimation for the Recommended Daily Allowance for Vitamin D. Grassroots Health has confirmed the error through testing of thousands of participants in their health initiative for vitamin D.

Many other errors have been made in vitamin D science over the years since its discovery:

  • Vitamin D2 is equal to vitamin D3
  • Selling vitamin D as a supplement in only 50 IU tablets that resulted in conspiracy charges of seventeen multinationals during WW II by the US (this sounds just like the error(?) made by the IOM)
  • Vitamin D is only useful for bone health
  • Dr. Cook’s description of birth defects from vitamin D in the 1960’s during the thalidomide scare
  • There is no warning label on sunscreen for the product preventing the body’s most significant steroid hormone from forming in your skin with exposure to the sun
  • Years of warnings by medical professionals about the dangers of the sun
  • Improper interpretation of findings in vitamin D research

It makes me wonder if it is just bad science, incompetence, idiopathic delusion, or orchestrated intention.

The only thing that I can tell you is from my own personal experience. Grassroots Health has it right. Have your serum 25(OH)D tested and then use the chart on Grassroots Health home page to achieve a level above 50 ng/ml. For more guidance on what level of vitamin D, take the advice of Dr. Mercola through his many years of practice.

And if you want to be proactive, sign the petition for Health Canada and the IOM to reevaluate its findings. – Pandemic Survivor

Okay, so maybe you are into a more poetic description: “Through epigenetic action of nuclear receptors as an orchestra, life is properly conducted by the vitamin D receptor. userprofiletileIn this auditorium, the microbiome listens and sustains life through applause.” Mark Pegram—inspired from discussions with Dr. P.R. Raghavan, developer of policosanol as a nano-emulsion, Metadichol®, a natural nuclear receptor agonist/inverse agonist when animals cannot get enough sunshine.

“Idolatry is committed, not merely by setting up false gods, but also by setting up false devils; by making men afraid of war or alcohol, or economic law, when they should be afraid of spiritual corruption and cowardice.” – G.K. Chesterton ILN, 9/11/1909

Endocrine Society ‘Thumbs Nose’ at IOM for Serum Vitamin D Levels

Endocrine Society ‘thumbs their nose’ at the IOM in announcing new clinical practice guidelines for vitamin D.  The IOM’s Food and Nutrition Board for vitamin D and calcium announced in November 2010 that the population had adequate vitamin D as long as the level of 25(OH)D was maintained at or above 20 ng/ml.  The new minimum by the Endocrine Society was established at or above 30 ng/ml for bone health.  The IOM made a big deal of the fact that they considered bone health only, but obviously got that wrong.  The Endocrine Society was initiated in 1916 to “to promote sound development and curb abuses” in relation to the new developments being made for the endocrine system.

Press Release:  Endocrine Society Announces New Clinical Practice Guidelines for Vitamin D

Medscape Article: Endocrine Society Issues Practice Guideline on Vitamin D

The Paper in the Journal of Clinical Endocrinology and Metabolism:  Evaluation, Treatment, and Prevention of Vitamin D Deficiency: an Endocrine Society Clinical Practice Guideline

I am very concerned that the Endocrine Society perpetuated the myth that vitamin D2 and vitamin D3 are acceptable for deficient patients.  This was done obviously to protect themselves from years of saying that D3 and D2 were equivalent in the human body.  This position has been firmly held by Dr. Michael Holick for his work in bone health.  It may be okay when considering bone health at serum levels below 50 ng/ml.  However, when getting the body up to levels of vitamin D found for people in a sunny country or levels necessary to protect against chronic disease like cancer and heart disease, vitamin D2 can begin to cause damage to the body, and this is the confusion in the literature.

The good news is that empathy for the patients being treated has been considered and not just the economic farming for the medical institutions.  This war of words that are played out in press releases and medical journals has now been going on for over eighty years.  We will get to the correct understanding eventually, but how many people have to die to maintain the profits of the medical/medical insurance industry?

For the best results in preventing disease, kept your serum 25(OH)D above 60 ng/ml.  There have been no cases of toxicity with a level below 200 ng/ml or people taking less than 30,000 IU of  D3 per day.    – Pandemic Survivor

Color My World Ultra Violet B

“As time goes on, I realize just what you mean to me…..color my world with hope…”  Chicago 1970.

This is a familiar song lyric made popular by the band Chicago.  Our relationship with the sun has forever changed with the introduction of sun screen and staying inside during the highest incidence of ultra violet B in the summertime because of the introduction of air condition and electronic entertainment.  It is a ‘love song’ being song now by many in the world of vitamin D research.  However, what I have discovered in writing this blog is that the researchers seem to be talking only to each other.  What is the point of this?  Until the medical profession embraces the idea that most chronic disease is created by not having enough vitamin D and this embracing is sanctioned by governments, we will continue in a state of severe disease.

The recent release by the Institution of Medicine findings through the Food and Nutrition Board on vitamin D and Calcium has been a major setback for moving forward in resolving disease states.  Even though they qualified the findings as pertaining to bone health only, the statements that there was not enough research to support higher amounts to stop disease gave medical institutions and government time.  Why is this time needed?

On April 27, Natural News published this article by Dr. John Cannell, Vitamin D Council, describing the need of the medical industry for time to develop vitamin D analogs.  Betrayal of a Nation: Why U.S. health authorities are keeping you deficient and who stands to gain.  http://www.naturalnews.com/032202_vitamin_D_deficiency_disease.html  He references an article that I wrote in December, Conflict of Interest at Nation Academy of Science, about the conflict of interest with members of the FNB for vitamin D.

The egregious violations of the National Academy of Science (IOM is a division) rules can only be allowed to occur by the sponsors.  The only answer is that both the government of Canada and the government of the US (primary sponsors) stand to gain significantly by maintaining an unhealthy population.  These governments did not only allow it to occur, but most likely sanctioned the results.  There is no greater institution of science than the National Academy in the minds of the public.  However, politics has entered this arena with the thought that a healthy population would lead to a significant reduction in the health care economy.  (I am not big into conspiracy theories, but here institutions are moving together with what they perceive is best for them without empathy for the individuals they serve.) If you had to make the decision between a healthy population and a healthy economy, which would you chose.  A thirty percent reduction in the healthcare economy from a healthy population would mean a five percent reduction in the total economy.  What would happen with all these additional unemployed people?  There is no simple answer.

With that many more people unemployed in the current economy would the economy of the world collapse?  Here is the fear by our leaders.  There will be no proclamation by the President or by Health and Human Services.  Yes the greed of the medical institutions, in particular medical insurance is driving the decision making process.  Our government leaders are allowing this to occur, not from lack of knowledge, but from fear of total collapse.  It has taken us seventy years to reach this point.  Read how the government was involved with vitamin D misadventure through the courts at my post Vitamin D for Profits – 1923 to 1946 https://pandemicsurvivor.wordpress.com/2010/12/09/vitamin-d-for-profits-1923-to-1946/  Will it take us another seventy years to reach a healthy understanding of our relationship with the sun?

Moving institutions is a daunting task, especially when there are significantly large amounts of money involved.  My hope is that people of science will stop considering only their individual incomes, the incomes of the institutions that employ them, and start considering the individuals they serve.  If not, by definition, they are practicing institutional evil.  Until these institutions start to move, our hope is the individual doctors that have embraced the science like my hero Dr. Joseph Prendergast, M. D., Endocrine Metabolic Medical Center.  Dr. Prendergast has treated upwards of four thousand people with vitamin D.  His take on vitamin D from you tube from 2007:  http://www.youtube.com/watch?v=_PYsXQ16Ztg

Of course, my personal physician, Dr. Mark Perini, is my hero because he was willing to listen to me, watched me healed and has fully embraced vitamin D science.  His practice has even purchased its own vitamin D testing equipment.  The point of this is that the message of the researchers is reaching our doctors and soon, whether sanctioned by government or not, we will move toward health through doctor peer pressure from amazing results.  Researchers, you are my hero as well, keep up the great work.  Keep reaching the doctors in any way that you can.

Color my world with ultra violet B – Pandemic Survivor

The Consequence of Institutional Evil

It is difficult to think about an institution being evil, unless of course we are thinking about institutions that operate outside of the law.  But what about an institution that operates inside of the law, is it still evil?  Before you dive right into this article perhaps you would like a lighter, easier to read understanding – then I would suggest that you read my post from November 21, 2009 Super Duper Vitamin D3!!

To get a better understanding of how evil manifests itself in institutions, I would like to turn to my favorite expert psychiatrist in this area M. Scott Peck, MD well known for his book A Road Less Traveled. This book is a best seller and has sold over six million copies, but less known is his book People of the Lie: The Hope for Healing Human Evil, Simon and Shuster 1983, was a best seller in Japan.  M. Scott Peck died Sept. 25, 2005 at his home in Warren, Conn.  Dr. Peck was 69 and had Parkinson’s disease as well as pancreatic and liver duct cancer.  Wonder if vitamin D deficiency was an issue?

We all recognize individual evil and how it can be manifested as narcissism or malignant self love.  That is a person that cares only about himself without empathy for others.  Institutional evil as described by Dr. Peck arises when an institution only cares about its survival without empathy for the individual.  In institutions, this develops because of specialization without a clear understanding of who is responsible for the moral compass.  Each member of the group does his specialized job without considering the outcome of what it means for the institution and the individuals that are served.  So the scientist researches, practitioners practice, and leaders lead.  Each is assuming that the other has the individual in mind.  We now jump to what happened with the IoM’s Food and Nutrition Board on Vitamin D and Calcium.

The FNB was given the responsibility to give an opinion based on the new research for the many diseases linked to vitamin D and what directions should be given to the general population by the government institutions of health in both the US and Canada.  The FNB members felt no responsibility for individuals except in bone health and stated so in their report.  Could it be that they did not realize that the popular press and the NIH would use this as general guidelines for the entire population?  This included suggesting that there was no need for a serum 25(OH)D level above 50 ng/ml,  and levels higher than that could be risky.  What is interesting about this last statement is that people in sunny countries have serum 25(OH)D levels that range from 50 to 90 ng/ml and yet the epidemiological studies show that many diseases are less prevalent in these sunny countries.  This includes many types of cancer, diabetes, heart disease, as well as many types of mental illness.  Since the FNB stated they considered bone health only, they felt no responsibility to individuals for preventing other diseases.  It has been left up to the individual doctor, responsible for following the medical guidelines, which are defined by Health and Human Services based on the FNB report.  Ah, the circularity in the logic of preventing disease and maintaining empathy for individuals.

Jump again to my friend that just recently had a stroke.  I suggested to him that he should to try to maintain his serum 25(OH)D level between 50 and 90 ng/ml as this was common for a sunny country and was most likely his summertime level as he loves to go into the sun.  The long time standards for serum 25(OH)D has been between 20 to 100 ng/ml for several decades.  Higher levels of vitamin D have been shown by medical studies to result in less strokes and heart disease.  He had just read a news article that said anything greater than 50 ng/ml might be risky.  He decided not to supplement or to go into the sun.  When he dies of a stroke or a heart attack, it will just be written off as another victim of chronic disease.  My heart breaks for the millions that have been misled by the newspapers and the scientist just specializing in what they do.  – Pandemic Survivor

Errors Continue in Vitamin D Science at AHRQ and Tufts

As I begin to research vitamin D and its functions in the human body, the first thing that I noticed was any compound that was related to vitamin D was called vitamin D.  I found these same errors in reading the AHRQ-Tufts Evidence Based Report on Vitamin D and Calcium.  Tufts was contracted by the Agency for Healthcare Research and Quality formerly known as the Agency for Health Care Policy and Research.  AHRQ is one of twelve agencies that report to Health and Human Services.  The IoM then used this report to make decisions about your health. The report was requested and funded by The Office of Dietary Supplements/National Institutes of Health, the Public Health Agency of Canada, Health Canada, and Food and Drug Administration.  You may access the report here as a pdf file.  It is also appendix D in the IoM report on vitamin D and calcium.

I think the ‘Policy’ name fits AHRQ better as they are responsible for maintaining clinical practice guidelines.  If you do not know, these guidelines drive the economy for the medical industry and are used as rules to determine if procedures were followed that can be paid for by the insurers.  As far as quality in the name, they produced a report that was far from what I expected.  As a taxpayer I was failed since they did not meet the quality standard.  Quality, as defined by the experts, is meeting customer’s expectations.  AHRQ mission statement: The Agency for Healthcare Research and Quality’s (AHRQ) mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

First Expectation:  Vitamin D2 and Vitamin D3 are not to be treated as equivalent substances in the human body.  This is from the report: “Whenever the type of vitamin D supplement (D2 or D3) was clearly reported, we extracted and reported this information. Otherwise, we used the general term “vitamin D”.” – pdf page 52 – report page 36

Second Expectation: The difference between serum levels of 25(OH)D for D2 versus 25(OH)D from D3 should be clearly defined or the research should be considered invalid.  There is no mention whatsoever that a distinction was considered when reviewing the literature.

Why do we expect this distinction between D2 and D3?  Because there are more than 2700 genes with vitamin D pathways and the difference of an additional methyl group or an additional double bond are huge.  As we learn more about how genes are turned off and on, vitamin D has become the major player in controlling gene switching for chronic disease.  I will give you the example of what was batted around by the press after the IoM report was issued about an increase in the risk of pancreatic cancer with an increase in serum 25(OH)D in Finland smokers.  It is well known that this country has offered stoss injections of vitamin D2 and D3.  Is the u-shaped curve that was much discussed different for D2 versus D3?  I think the answer is yes.  There have been many recent papers discussing the difference in the two compounds, but the one that sticks in my mind is the Moon and Reich paper from 1975.  The Vitamin D Problem, and Important Lesson in Orthomolecular Medicine. Link to pdf

In this paper we find that the reports of toxicity did not even start to occur until the introduction of irradiated ergosterol, vitamin D2 or worse an unwanted compound from this process apply named toxisterol.  Vitamin D2 is a compound made from a fungus.  There had been years of supplementing with large amounts of cod liver oil without incidence except for two reported by the same doctor.  During the next several decades the compounds started to be treated as equivalent, for economic purposes I suspect.  The reports on toxicity started rolling in every month.  Only irradiated 7-dihydracholesterol produces vitamin D3, it was much easier to irradiate other sterols for profit.  Moon and Reich listed diseases that are made worse by D2.  Here are a few: Atherosclerosis, Rheumatoid Arthritis, Peripheral Vascular Disease, Idiopathic Hypercalcemia.  Could pancreatic cancer or prostate cancer be a couple of others?

Third Expectation:  The amounts of vitamin D considered should be large enough to make a clinical difference in outcomes.  The IoM committee covered themselves on these diseases by bluntly stating that the report only covered bone health.  The AHRQ-Tufts report in many cases used studies for chronic disease that reported a difference between 400 IU versus 800 IU of intake per day.  Why would they think that two minutes in the sunshine versus four minutes makes a clinical outcome difference in cancer?

Based on this lack quality in the AHRQ-Tufts report and consequently the IoM report, I reject both as not being of quality for my use.  However, the patent holders of vitamin D analogs, I am sure, are delighted.  – Pandemic Survivor

Unintended Consequence of IoM Vitamin D Levels

I suspect business considerations were not made by the panel for vitamin D and calcium (well – maybe some conflict of interest that we hope gets investigated).  That is the way it is supposed to be to prevent conflict of interest.  So who reviews the standards for unintended consequence?  We would have to assume that it is one of the divisions of HHS.  There is a huge consequence that has been alluded to by several of the researchers in responses.  However, no one has stated how costly it will be for employers of people that work in the sun.

Yesterday, I visited the Gov’s (NIH) vitamin D fact sheet to see how they had interpreted the advice of the committee.  (The good news is that I tried to just go there again to confirm what I had read and the server was busy!)  They pretty much stated that you should not have your serum 25(OH)D3 level above 50 ng/ml because there could be risk (probably too high – what does that mean?).  This immediately triggers the Department of Labor to act through OSHA to assure that no one is unduly exposed in their place of employment to hazards.

So what does this mean for the tens of thousands of life guards at pools and beach life guards that are constantly exposed to the sun?  Are they going to have to test on a regular basis to assure their employees do not go above the 50 ng/ml?  This is typical of what is necessary to protect employees against environmental exposures in the work place.  The employer then most take steps to get the employees level down.  More sun block (which could cause more melanoma as there is a straight line relationship between sunscreen use and melanoma, of course you can’t claim this without clinical trials according to the ‘rules’ – if you do not believe the straight line relationship see this video of Edward Gorham, Ph. D. presenting his paper –Skin Cancer/Sunscreen the Dilemma at GrassrootsHealth.net  The higher rates of melanoma that we are currently experiencing is another of those unintended consequences of dermatologist saying that sunscreen would reduce cancer.  They were right about the milder forms of skin cancer like basal cell.) and clothes that could interfere with required quick response to rescue.  An umbrella overhead would not do the job because of the better than 90% reflectance of UV light off the water.  It is not unusual for life guards to exceed 125 ng/ml.  People in sunny countries, and I suspect people that work regularly in the sun, typically have serum levels between 54 ng/ml and 90 ng/ml.  The Gov’s fact sheet on vitamin D that was replaced stated that serum levels < 200 ng/ml were safe.

So if we extend this to workers that go into the sun, it could have a huge impact on farming and construction – cost of not exposing the employee to environmental hazards and lost productivity because of the necessary protection from the sun.  This should be a great lesson to any scientist that just wants to set an arbitrary level because it ‘feels good’.  Okay, workers in the sun, long sleeve shirts, sun hats, long pants are the order of the day.  I did this growing up working the fields in North Carolina and I suffered severe degenerative disc disease.  Thank God that was all that happened and not cancer.  If you think the IoM, in the famous words of TV character Dr. House, are ‘idiots’, then go to – Action Alert: Is the Institute of Medicine in Bed with Big Pharma? at the Alliance for Natural Health – USA, read the article and sign the petition if you feel comfortable.  – “Our relationship to the sun has forever changed” – Edward Gorham.  Nekkid in the sun a hazard?! – Pandemic Survivor

Conflict of Interest at National Academy of Science?

The NAS has a very strong position toward independence of business and politics and tries to maintain a position of science. NAS Conflicts of Interest Policy: “Finally, it is essential that the work of committees that are used by the institution in the development of reports not be compromised by issues of bias and lack of objectivity.”

The Institute of Medicine is a division of the National Academy and one of its responsibilities is to determine the daily required intakes of nutrients through its Food and Nutrition Boards.  I thought that it would be interesting to see if there was opportunity for conflict on the recent FNB for vitamin D and calcium.

Before we can decide if there exists a conflict of interest, we must first establish opportunity.  It is well established that the larger the amount of money involved, the larger the opportunity for conflict.  (Aside, I just love how today we mince words and use words like conflict instead of corruption.)  I asked the question about how large the vitamin D industry could be.  I decided to use Dr. William Grant’s, an epidemiologist with SUNARC, studies.  He has stated that moving the serum level of vitamin D, 25(OH)D, from 20 ng/ml to 40 ng/ml would reduce all cause mortality by fifteen to twenty percent and reduce the medical economic burden by ten percent.  The five studies done to arrive at these numbers were for Canada, US, Netherlands, Nordic countries, and Western Europe.  If we estimate the size of the Canadian and US medical economy at 2.5 trillion dollars per year then a reduction in economic burden ten percent would be 250 billion dollars.  The recent FNB decided to keep the standard target for 25(OH)D at 20 ng/ml as that is high enough for bone health and most of the population is close to that level.

Before we proceed, you should understand the meaning of a pharmaceutical analog.  An analog is something that represents or analogous to another thing.  In chemistry, an analog only needs to have a similar structure, but not necessarily the same chemical and biological properties.  This allows the maker of an analog for a natural substance to develop patents for commercial purposes.

You will have to decide if the following board advisor and member had conflicts.

Consultant – Hector F. DeLuca, University of Wisconsin Madison

This from the Wisconsin Alumni Research Foundation http://www.warf.org , an entity designed to develop patents and income from licensing arrangements for the patents.  The holder of the patent gets twenty percent of the royalties from the licensing according to information from WARF’s web site.

Business opportunity on osteoporosis and other bone disease from WARF http://www.warf.org/industry/index.jsp?cid=55&scid=76

Business Opportunity

  • Osteoporosis is a growing market and under-diagnosed disease in the United States. In 2009 it is estimated that 11 million people and 18% of the US population over the age of 50 have osteoporosis. This number is expected to exceed 14 million by 2021.
  • The U.S. osteoporosis market generated revenues of $4.7 billion in 2008 and is expected to generate $6.5 billion by 2021.
  • Almost 90% of the treatments currently marketed for osteoporosis do not provide anabolic bone formation activity as their mechanism of action.
  • A clear need exists for new products that can improve current approaches to reducing fracture risks by forming new bone as well as preserve existing bone.
  • Extensive intellectual property rights may already be established in major market areas.

At the present time, a significant late stage commercialization opportunity is available through our Licensee, Deltanoid Pharmaceuticals. For further information, please contact our office.

Additional Information
For more information about the inventor, see Hector DeLuca

Prostate Cancer: UW–Madison researchers are designing non-calcemic analogs of calcitriol with anti-cancer effects on prostate cancer cells.

http://www.warf.org/industry/index.jsp?cid=55&scid=77

Business Opportunity

  • Prostate cancer is a growing market worldwide.
  • A need remains unmet for non-invasive treatments and fewer treatment-related side effects.
  • A major gap in the market exists, offering high commercial potential for second line treatment of hormone refractory prostate cancer (HRPC).

Applications

  • Treatment for all forms of prostate cancer.
  • Suitable as an oral or intravenous formulation.

Key Benefits

  • A proven biologically active compound that stops growth of prostate cancer cells.
  • Provides a safer, less calcemic compound than the natural hormone calcitriol.
  • Offers a fresh therapeutic approach for gaining access to the cancer therapy market.
  • Provides a drug development opportunity in a growing market space.
  • Innovative licensing and development terms available.

Stage of Development
The analogs offered in this portfolio have been subjected to in vitro/in vivo models for early-stage pre-clinical evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.

Additional Information
For more information about the inventor, see Hector DeLuca

Psoriasis: http://www.warf.org/industry/index.jsp?cid=55&scid=78

WARF maintains a robust and growing portfolio of low and non-calcemic analogs of calcitriol. Intellectual property rights and special development incentives for commercialization in the psoriasis space are currently available.

Business Opportunity

  • Through 2006, the prevalence of psoriasis was estimated to be 17 million people worldwide.
  • Datamonitor reports $1.95 billion in sales of psoriasis treatments in 2005.
  • By 2015 the market for psoriasis treatments will exceed $2.3 billion in the U.S., $832 million in the E.U. and $354 million in Japan.
  • An increasing demand exists for safer therapeutics that control symptoms with greater efficacy, longer duration and improved quality of life.
  • Providers view vitamin D analog treatments as first line options versus steroids due to safety concerns and also over biologic treatments as payers carefully scrutinize risk-benefit and cost-benefit ratios.
  • Next generation vitamin D treatments are needed to replace older products with narrow therapeutic indexes.

Applications

  • Mild psoriasis
  • Severe psoriasis

Key Benefits

  • A proven biologically active compound that slows the growth of skin cells with minimal potential for raising calcium levels.
  • May enable less frequent dosing and increase in size of treatment areas.
  • Early pre-clinical screening studies completed; later stage pre-clinical and clinical GLP evaluations may be available.
  • Offers a fresh therapeutic approach for gaining access to the growing psoriasis and skin therapy market.
  • Innovative licensing and/or development terms available.

Stage of Development
The analogs offered in this portfolio have been subjected to in vitro/in vivo models for evaluations of receptor binding, cell proliferation, cellular differentiation, calcium mobilization and blood calcium levels. In some cases, Good Laboratory Practice (GLP)-rated pre-clinical and clinical data may be available for evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.

Additional Information
For more information about the inventor, see Hector DeLuca

Chronic Kidney Disease: http://www.warf.org/industry/index.jsp?cid=55&scid=79

Business Opportunity

  • The market for vitamin D analogs used to treat SHPT and renal osteodystrophy in the U.S. was estimated to be worth more than $800 million at the end of 2008.
  • The U.S. Renal Data Service (USRDS) estimated approximately 330,000 people received dialysis treatment for stage 5 CKD in 2006 and that the U.S. CKD population is expected to increase 60% by 2020.
  • In 1997, treatment of diabetic patients with stage 5 CKD in the U.S. cost more than $15.6 billion.
  • Improving treatment outcomes relating to bone and mineral disorders is a central theme in CKD patient management strategies.

Applications

  • Oral and intravenous treatments for management of SHPT and renal osteodystrophy in CKD patients.
  • Prevention or treatment of diabetic nephropathy.
  • Maintenance of kidney function in patients with early stage CKD.

Key Benefits

  • Proven biologically active compounds selected to target and suppress PTH levels.
  • Provides safer, less calcemic and less phosphatemic compounds than the natural hormone calcitriol or currently marketed treatments.
  • Offers a fresh therapeutic approach for gaining access to the kidney disease market.
  • Provides a drug development opportunity in a growing market space.
  • Strong intellectual property rights and development incentives are available.

Stage of Development
Many of the analogs offered in this portfolio have been subjected to in vitro/in vivo models for evaluations of receptor binding, cell proliferation, cellular differentiation, bone and intestinal calcium mobilization. In some cases, Good Laboratory Practice (GLP)-rated pre-clinical and clinical data may also be available for evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.

Additional Information
For more information about the inventor, see Hector DeLuca

Type 1 Diabetes: http://www.warf.org/industry/index.jsp?cid=55&scid=80

WARF maintains a robust and growing portfolio of low and non-calcemic analogs of calcitriol. Intellectual property rights and special development incentives for commercialization in the type 1 diabetes space are currently available.

Business Opportunity

  • Diabetes affects 246 million people worldwide and nearly 8% of the U.S. population. By 2025 experts predict 380 million people will be afflicted with diabetes.
  • In 2007, the five countries with the largest numbers of people with diabetes were India (40.9 million), China (39.8 million), United States (19.2 million), Russia (9.6 million) and Germany (7.4 million).
  • Global diabetes treatment market was valued at over $21 billion in 2006.
  • The Juvenile Diabetes Research Foundation estimates there are over 3 million people in the US with T1D and nearly 15,000 new cases of T1D diagnosed yearly.
  • Multiple source funding is available for diabetes translational research.

Applications

  • Prevention of type 1 diabetes in humans and other animals.

Key Benefits

  • A proven biologically active compound with beneficial effects on beta cell and immune function.
  • Provides a safer, less calcemic compound than the natural hormone calcitriol.
  • Offers a fresh therapeutic approach for gaining access to the diabetes market.
  • Provides a drug development opportunity in a growing market space.
  • Innovative licensing and/or development terms available.

Stage of Development
The analogs offered in this portfolio have been subjected to in vitro/in vivo models for early-stage pre-clinical evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.

Additional Information
For more information about the inventor, see Hector DeLuca

Multiple Sclerosis: http://www.warf.org/industry/index.jsp?cid=55&scid=81

At UW–Madison, promising research is underway with several noncalcemic vitamin D analogs that show efficacy in the EAE mouse model. These analogs may provide the solution to the dose limitations of calcitriol by offering a wider dose range and lower potential for causing hypercalcemia and its complications.

Business Opportunity

  • Cure for MS is a large and unmet medical need.
  • More than 350,000 individuals in the U.S. are affected.
  • 200 new cases are diagnosed each week.
  • Annual cost of MS in the U.S. is in the billions of dollars.

Applications

  • Prevention and treatment for MS

Key Benefits

  • A proven biologically active compound that may reduce the risk of developing MS or slow the progression of the disease.
  • Provides a safer, less calcemic compound than the natural hormone calcitriol.
  • Offers a fresh therapeutic approach for gaining access to the MS therapy market.
  • Provides a drug development opportunity in a growing market space.
  • Innovative licensing and development terms available.

Stage of Development
The analogs offered in this portfolio have been subjected to in vitro/in vivo models for early-stage pre-clinical evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.

Additional Information
For more information about the inventor, see Hector DeLuca

Committee Member: Glenville Jones, Head, Department of Biochemistry and Professor of Biochemistry and Medicine, Queens University, Ontario

April 23, 2007 from the Queen’s Gazette Forum – by Glenville Jones “Steenbock’s Legacy: More than Vitamin D Fortified Milk” http://www.parteqinnovations.com/pdf-doc/fandr-Gaz0407.pdf about what Mr. Jones learned from the University of Wisconsin Madison and how analogs have helped millions.

From Cytochroma, Inc. web site: “Promoting Health through Vitamin D Therapies”

Mr. Jones is co-founder Cytochroma, Inc. and is on their advisory board: http://www.cytochroma.com/about_us/scientific_ad_board/jones.html

Dr. Jones is Craine Professor and Head, Department of Biochemistry at Queen’s University. Dr. Jones is an internationally respected researcher in the field of nutrition, metabolism and vitamin D. He was a founding member of the advisory board of the Canadian Institute of Nutrition, Metabolism & Diabetes, and has served six terms on the scientific program committee of the International Workshop on vitamin D. In 2004 Dr. Jones received a Career Achievement Award for his scientific contributions to the vitamin D field at the Thirteenth International Workshop on vitamin D.  Dr. Jones is a graduate of Liverpool University (BSc, PhD) and completed postdoctoral work at University of Calgary and University of Wisconsin, Madison. Prior to his appointment to Queen’s in 1984 he was a faculty member at the Hospital for Sick Children and University of Toronto. Dr. Jones is credited with the discovery of 1,25(OH)2D2 and is a named inventor on numerous patents and is author of more than 200 papers and presentations.  Dr. Jones is a co-founder of Cytochroma.

Statement by Glennville Jones after Cytochroma reached a licensing agreement with John Hopkins University for a vitamin D enzyme inhibitor from The Free Library http://www.thefreelibrary.com/Cytochroma+Inc.+licenses+novel+chemical+compounds+from+Johns+Hopkins…-a067579561 :  “Vitamin D plays a vital role in maintaining calcium levels in the body and in the regulation of cell proliferation and cell differentiation,” stated Dr. Glenville Jones, Co-Chief Scientific Officer responsible for the vitamin D program at Cytochroma. “We have every confidence this approach will lead to new drug candidates to treat malignancies which overexpress CYP24, such as prostate, breast and lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell.

Have you decided yet about conflict of interest?  I guess the over site committee at the NAS was comfortable with the choices.  Does keeping the target 25(OH)D at 20 ng/ml allow for more business opportunity?

For information on possible conflicts see: http://www.vitamindwiki.com/tiki-index.php?page_id=1198