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

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

At the provided link, hear or read the interviews between Dr. Mercola, Dr. John Cannell, founder Vitamin D Council, and Carrole Baggerly, founder GrassRootsHealth on their take of the IoM decisions on vitamin D.

http://www.lewrockwell.com/orig5/mercola83.1.html

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

Action Alert: Is the Institute of Medicine in Bed with Big Pharma?

The Alliance for Natural Health USA is to petition Congress to investigate the IoM.  Please follow the above link, read the article, and if you feel comfortable – sign the petition.  It will go to your congressman and two senators.

Thanks,

Pandemic Survivor

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.

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.

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