Vitamin D Regulates T cell and NK Cell Function
A review article on the role of vitamin D and the regulation of T cells was published in April 2015 in Nutrients journal. (1) The article is referenced by 61 scientific publications. The authors found that vitamin D is a direct and indirect regulator of T and NK cells. Adequate vitamin D serum levels is essential for optimal functioning of T cells, NK cells, and other types of white blood cells including CD8 cells and macrophages. (2) They also report that T cells and Natural Killer cells have receptors for vitamin D.
In experiments on mice, the researchers found vitamin D inhibited IL-2, IL-17 and IFN-y while inducing IL-4. By inhibiting pro-inflammatory cytokines, vitamin D acts like an “engine throttle” on the immune system. Natural killers (NK) cells are a type of white blood cells that provide innate immunity. Innate immunity means that NK cells can independently hunt down and destroy a wide range of foreign proteins including but not limited to viruses, bacteria, fungi and cancer cells. T cell and NK cell dysfunction is evident in most forms of cancer, HIV, HBV, TB, Multiple Sclerosis, inflammatory bowel disease, and autoimmune diseases.
Chronic over-activation of T cells is involved in a number of diseases including rheumatism, respiratory diseases, cancer, AIDS, and other pathologies. (1) Vitamin D as an anti-inflammatory hormone has effects similar to cortisol, the body’s main anti-inflammatory hormone produced by the adrenal glands. Adequate vitamin D supplementation can help reduce stress, both mental and physical, as well as help to mitigate depression and mood swings.
Ref: 1. Vitamin D and 1,24(OH)2D Regulation of T cells Margheritta T Cantorna et al, Nutrients 2015, 7, 3011-21
2. The effects of vitamin D on the immune system by Kikuta J1, Ishii M. Clin Calcium. 2015 Mar;25(3):359-65.
Vitamin D for Allergic Rhinitis, Sinusitis, Bronchitis, and Asthma
In April 2015, an article was published in the Journal of Steroid Biochem Mol Biol (1) on the use of vitamin D in the treatment of respiratory illnesses. The authors were Yawn J, Lawrence L, Carrol W and Mullingan J. In their abstract they report that
“A large number of human, animal and in vitro studies have suggested that vitamin D3 (VD3) plays a critical role in inflammatory airway diseases such as asthma, chronic sinusitis, and allergic rhinitis.” (1)
The authors report that vitamin D affects, in a positive way, the functioning of a wide range of white blood cells including T cells, dendritic cells, macrophages and B cells. They report that vitamin D also regulates the function of non-immune cells including “epithelial cells, fibroblasts, and smooth muscle cells.” The article discusses trials where vitamin D was used in various doses in the treatment of asthma, rhinosinusitis and allergic rhinitis.
1. Vitamin D for the treatment of respiratory diseases: Yawn J, Lawrence L, Carrol W and Mullingan J. Journal Steroid Biochem Mol Biol. 2015 Apr; 148:326-37
Scientists find that vitamin D regulates the expression of over 900 genes
Scientists in South Africa have studied the anti-inflammatory and antimicrobial effects of vitamin D supplementation on Mycobacterium tuberculosis (MTB) and HIV-1 infection. They found that vitamin D binding to cell receptors regulates the activity of over 900 genes. They have linked vitamin D deficiency to the following conditions –
“Types 1 and 2 diabetes mellitus, rheumatoid arthritis, cardiovascular disease, osteoporosis, multiple sclerosis, depression, irritable bowel disease, asthma, colorectal, lung and breast cancers, upper respiratory tract infections, tuberculosis (TB), and HIV/AIDS progression and mortality [1–6]. “
No longer is vitamin D considered solely a regulator of calcium and bone homoeostasis; it is now recognized to have a diverse range of physiological functions, including cellular differentiation, proliferation, activation, and death .
One reason for its pleiotropic actions is the fact that vitamin D differs from most other vitamins in that its primary active metabolite, 1a,25-dihydroxyvitamin D (1,25-OHD) is a steroid hormone. Besides an increased risk for developing tuberculosis (MTB), they found an increased risk of mortality from HIV infected groups who were deficient in vitamin D.
They found that vitamin D supplementation with its anti-inflammatory effects helped to prevent damage to the lungs when MTB is active. They also report that vitamin D may help clear HIV and TB viruses from reservoirs and stated:
“While ARV is successful in decreasing HIV viral load and improving CD4 cell count, these observations suggest that vitamin D supplementation may have the ability to target clearance of the tissue viral reservoirs that ARV is unable to eradicate, potentially further decreasing TB risk in HIV-1 infected individuals.” (1)
1. Anti-Inflammatory and Antimicrobial Actions of Vitamin D in combating TB/HIV Anna Coussens, Adrian Martineau et al. published in Scientifica, Volume 2014, Article ID 903680
NYC HIV Case – no cure yet even though the CD4/CD8 ratio had returned to normal
9/15/2015 NYC. The unexpected results of combining the HIV drug, Complera, with Black Seed powder and beet juice resulted in an unprecedented return to a normal CD4/CD8 ratio in just 3 months This report is about a female from Harlem, NY. I will call her “Mary” not her real name. Here is a shortened version of her latest phone call to me on Sept 14, 2015.
She is married and her husband is HIV positive. Mary became infected in January 2015 after having had sex in an encounter that resulted in the breakage of a condom. About a month later, at the end of February 2015, she tested positive for the HIV virus.
More testing found her CD4 counts had dropped to around 340 while the CD8 count rose to 809 – the result being a CD4/CD8 ratio of 0.42. The viral load for HIV was about 21000. [The immune system's initial response to the HIV virus is to flip or invert the CD4/ CD8 ratio. A typical example of a normal CD4/CD8 ratio before HIV is a CD4 count of 800 and a CD8 count of 500. If you divide 800 by 500, you get 1.6 and that would be a normal CD4/CD8 ratio.]
A few months ago, on May 15th I wrote why I thought we needed to pay more attention to the CD4/CD8 ratio. The usual reference range for a person who was never exposed to the HIV virus is between 1.0 and 2.0. After HIV infection, you get the opposite – an example is a CD4 count of 400 and a CD8 count of 800. When you divide 400 by 800 it is 0.5 that is a typical ratio for someone who has active HIV infection. A CD4/CD8 ratio of less than 1.0 normally occurs when the immune system detects and responds to active HIV.
CD4/CD8 ratio returns to normal
The return to a normal CD4/CD8 ratio is not only important in HIV/AIDS because it is so unusual, but because it also suggests the reversal of an inflammatory immune response. A quiet or non-excited immune response is thought to slow or stop HIV replication altogether.
In Dr. Onifade's studies in Nigeria, we were not given information on the CD4/CD8 ratios or if black seed therapy changed those ratios. We also do not know the blood serum levels of vitamin D in the Nigerian cases. In my opinion, of the 7 reported cures of HIV/AIDS in Nigeria, these cures should have included a return to a normal CD4/ CD8 ratio.
A 6-month timeline of events
Around March 11, patient M's doctor prescribed the pharmaceutical drug Complera, a once a day complete HIV treatment regimen in one pill. The ingredients in Complera, its benefits and side effects, can be found at complera.com.
On March 19, she used a coffee grinder to grind 4 teaspoons of whole black seeds into a powder, which she mixed with water and took this twice a day for one month, and then she reduced the dosage to two teaspoons twice a day. She also blended 2 whole raw beets with a quart of water and made a smoothie. She drank ½ cup of the raw beet juice smoothie each day since March of 2015.
About 9 weeks later at the end of May, she had new lab results and they were – CD4 counts 560. PCR viral load for HIV now undetectable. The CD8 dropped to 383 and the CD4/CD8 ratio returned to a normal reference range at 1.46.
In June after reading about the importance of vitamin D at Keep Hope Alive, she asked her doctor to test her for vitamin D levels. He did and they were low at 34 ng/ml. He then prescribed 50,000 i.u. of vitamin D which she has taken once a week since the middle of June.
On August 28, she had new lab results and they were – CD4 count 596. CD8 count was 310 and the CD4/CD8 ratio climbed to 1.92. She went to CVS Pharmacy and paid $50 for the Oraquick HIV saliva test. The result came back negative. Then, questioning the test, she went to a local hospital and had a blood test. The results came back positive for HIV antibodies from the hospital test. She told her doctor the conflicting results. He then ordered a P24 antigen test to see if an active HIV virus remained in her system.
P24 antigen still present
“Mary” said her doctor found that the p24 antigen, a component of the HIV virus still was present in her blood. Even though PCR indicated a non-detectable viral load, this test indicates the presence of a component of the HIV virus. The p24 antigen protein should not be present if the HIV virus has completely vacated the scene. This was a disappointment but failures of hoped for AIDS cures have scattered the landscape for over 25 years.
[I recall cases in the early 1990’s where the blood of HIV infected patients was treated with ozone and the HIV antibody test came back negative after a few weeks. However, a month of two later after ozone therapy was discontinued, the HIV antibody returned using the standard HIV elisa/western blot tests.]
Sept 25th “Mary” adds 10,000 i.u. of vitamin D to her daily regimen
While her doctor prescribes 50,000 i.u. of vitamin D2 to be taken once a week, “Mary” told Keep Hope Alive that she decided to up her vitamin D intake by 10,000 i.u. daily by taking an over-the-counter vitamin D supplement. She indicated that she will gradually increase her serum vitamin D levels to a point that flushes out the remaining viral reservoirs in her system. The doses used in the other parts of her protocol (the Complera, the Black Seed powder, and beet juice) will remain the same. We will follow and report on this case very closely. Vitamin D as a supplement is available in some health food stores at the 10,000 i.u. per dose. Otherwise, two 5000 i.u. capsules provide the same dosage.
Commentary and Analysis
In the 7 cases from Nigeria where the black seed powder and honey mixture apparently “cured” them of HIV/AIDS, there are two important pieces of lab data that are missing in the published studies. They are – 1. What were the blood serum levels of vitamin D during these trials? 2. Did the CD4/CD8 ratio return to a normal reference range as would be expected if a cure actually occurred?
In Mary’s case we know that vitamin D levels were low. I recently hypothesized that high vitamin D levels used along with black seed were necessary components of the 7 Nigerian “AIDS cures.”
Other case reports on Vitamin D
California: In this report, a reader named “Lee”(1) said he has been taking 10,000 i.u. of vitamin D for over 3 years, and that based on the Life Extension Foundation test, his vitamin D levels are at 83 ng/ml (2). Lee said his research indicates that the most benefits of vitamin D occur when you are in the upper quadrant of lab results – that is a vitamin D level from 75 to 100 ng/ml. Lee, who also takes a number of other supplements including whey protein powder never indicated his reason for doing this, but neither did we ask.
1. Lee is a pen name used in this article to protect his privacy rights.
2. ng/ml is nanograms per milliliter.
Local Cancer Cases and Vitamin D
Donna – who has bone cancer, is a local cancer patient I reported on in the last issue of JOI (vol 13 No2). Her doctor has combined conventional low-dose chemotherapy with immune based, diet and nutritional therapies and appears to have stabilized her condition for now although she walks with a cane. She told me she recently decided to up her vitamin D dose to 20,000 i.u. daily. She has also added ½ cup daily of Biotta beet juice, a fermented drink sold in health food stores.
She continues to take high doses of plant-based selenium (800 mcg daily) and black seed powder although she said she has recently developed stomach sensitivity to the use of the black seed powder and may have to discontinue its use. She is considering switching to Chaga, a mushroom that is grown on birch trees. Chaga is reported in several published studies to have powerful anti-cancer properties. Planetary Formulas and North American Herb and Spice Co. distribute the Chaga mushroom supplements.
Vitamin D levels extremely low in local lung cancer patient
A local resident who has lung cancer and cancer on his chin, the probable result of smoking cigarettes for over 30 years has been treated locally by oncologists with chemotherapy. Surprisingly, he tolerated the chemotherapy well. When it was suggested he have his vitamin D levels checked because of constant lower back pain he did and was surprised that it was in the basement at 8 ng/ml.
His oncologist was surprised and immediately prescribed 50,000 i.u. of vitamin D taken once a week. After 6 weeks his serum levels increased to 18 ng/nl. He reported slightly less back pain. Seeing his regular physician, he was told not to be surprised to see the dose doubled and that he would likely need to be on vitamin D supplements for the rest of his life.
My Personal Vitamin D Update
My personal test results, after increasing my intake of Vitamin D3 to 10,000 i.u. .daily from 5000 i.u. for the past 6 weeks is that my blood serum level has increased from 31 to 47 ng/ml. I also tan indoors 20 minutes a day 3 times a week. The florescent tubes in the sun bed I use emit both UVA and UVB rays that parallel the sun's radiation output. It is only the UVB rays that cause the production of vitamin D in the skin. It took six weeks (from around July 7th to August 20th) to accomplish this significant increase in serum levels of vitamin D.
The result of these tests have convinced me that I have been deficient in vitamin D all my life and that this has had significant adverse consequences for my immune system and health in multiple ways. Here are some of the benefits from increasing my intake of vitamin D that I have observed in the past 3 months.
1. 95% of the psoriasis I have had on my knees and elbows for the past 50 years is gone.
2. Periodic bouts of asthma have stopped.
3. Joint pain is gone. I no longer need to take Turmeric, Curcumin or Glucosamine Sulfate. A pain in my right foot that has periodically bothered me for the past five years has simply vanished.
4. Sleep interruptions have decreased from 3 times per night to just once per night and the quality of sleep has improved with the restoration of dreams, pleasant dreams at that.
5. Sinus infections have all but ended. (I still have to restrict my intake of milk and ice cream, but I tolerate cheese, yogurt and cooked milk much better than before vitamin D supplementation.)
6. Hay fever due to ragweed intolerance (a life long problem) has been barely noticeable this year.
Witch Hazel – a traditional remedy used by American Indians has anti-inflammatory, antiviral, and anti tumor effects
Witch Hazel (Hamamelis virginiana) is a small tree that grows up to 15 ft in height and has elliptic leaves. The deciduous shrub has crooked branches. It blooms with yellow flowers in the fall when the leaves are falling. The seeds or pods ripen the following autumn. Its branches have been used as devining rods.
The colonists obtained Witch Hazel from Native American Indians who used a decoction made from Witch Hazel bark or leaves for it many health properties. Witch hazel was listed in the U.S. Pharmacopoeia from 1862 to 1916 as an astringent and anti-inflammatory. The bark and leaves are the usual part used for their medicinal properties. The effects of Witch Hazel are astringent, tonic, sedative, diuretic, demulcent, anti-inflammatory and antiseptic (1,2, 3. 4).
Witch Hazel has been used both externally and internally. The alcoholic versions of Witch Hazel are preferred for topical or skin application. The non-alcoholic extract may be used topically or for oral use. Thayer’s makes both versions - an alcoholic and a non-alcoholic one. The non-alcoholic Witch Hazel is in a base of aloe vera; Both types are sold in health food stores. Witch Hazel bark or leaves may also be used to make an herbal decoction for oral or topical use.
Scientific Research on Witch Hazel
Witch hazel (Hamamelis virginiana) fractions and the importance of gallate moieties--electron transfer capacities in their antitumoral properties. by Reyes-Zurita FJ, de Kok TM, van Delft JH, et al. Department of Biochemistry and Molecular Biology, unit associated with CSIC, Faculty of Biology, University of Barcelona, Biomedicine Institute of the University of Barcelona, Barcelona, Spain.
Excerpt: “This study examines the response of human colon cancer cells to treatment with fractions obtained from a witch hazel polyphenolic extract. The results are compared with those obtained previously with homologous fractions from grape (less galloylated) and pine (nongalloylated). Witch hazel fractions were the most efficient in inhibiting cell proliferation in HT29 and HCT116 human colon cancer cell lines, which clearly shows that the more galloylated the fractions, the more effective they were at inhibiting proliferation of colon cancer cells.”
[Note: Searches using the term “Witch Hazel” at the National Library of Medicine produced 110 links to scientific articles on 8/13/15] A search using the Latin term Hamamelis virginiana yielded 217 links.
Witch Hazel’s Historical Use as a Folk Remedy
Topical use: Alcohol based Witch Hazel may be used topically or as a mouth rinse for gum inflammation, hemorrhoids, and infections including yeast based athletes foot, vaginitis and jock itch. Witch Hazel may also be used for varicose veins, peripheral neuropathy, skin cancer, boils, internal bleeding, burning or tingling feet, inflamed nerves, numbness sensations in the skin, and inflamed skin conditions.
Webmd reports that Witch Hazel has been used topically for – itching, inflammation, skin or muscle injury, insect bites, bruises, burns, varicose veins and hemorrhoids. Witch Hazel as an alcohol extract is available in drug stores and in health food stores.
Internal use: Webmd reports that witch hazel has taken by mouth and used for diarrhea, vomiting, coughing up blood, colitis, colds and fevers, tuberculosis, tumors and cancer. Its effectiveness in rapidly shrinking hemorrhoids makes it a plausible candidate for shrinking internal tumors and cancers. The bark of Witch Hazel contains the same anti-oxidant (proanthocyanidins found in French Maritime pine bark). Witch Hazel is reported by all available sources to be safe to use and well tolerated.
Side effects: Witch Hazel like Thayer’s that is not distilled has natural tannins in it and may cause an allergic reaction in some people. To test your self for a possible allergy, apply some of this or other brand named Witch Hazel solutions to your hand or arm for a day or two and observe if any rash or allergic reactions occurs. If a reaction occurs, consult a health care professional for advice.
Case Reports: A local resident reported that he cured himself of hemorrhoids by soaking a cotton cloth in the extract and holding it against the hemorrhoids for about 3 minutes. This person reported the Witch Hazel he used had alcohol in it and burned for a few minutes, but that he was cured over 10 years ago with just one treatment.
Another person I talked to also reported similar results using Witch Hazel topically for hemorrhoids. In another local case, the use of Witch Hazel applied over the feet stopped a burning sensation caused by athlete’s foot. In yet another case, nerve pain, thought to be neuropathy, was substantially alleviated with a few applications of Witch Hazel poured directly from the bottle over the affected area, then massaged in.
Additional case reports wanted on the use of oral Witch Hazel decoction for pain relief anywhere in the body, viral infections like HIV, HCV, HBV, EBV, tuberculosis, and any other chronic infection including influenza A virus.
We are also very interested in learning about the effects of Witch Hazel on arthritis, cancers and tumors when it is applied topically to the diseased areas of household pets. Other conditions we would like to hear reports on are arthritis, rheumatism, back pain, both lower and upper, neck pain, and pain in any other areas of the body.
How to make a decoction using Witch Hazel bark
Witch Hazel decoction may be made from the bark by placing 1 rounded teaspoon in a cup of boiling water. Reduce heat to a simmer and simmer with cover on pot for 10 minutes. Turn off heat and leave cover on pot for an additional 10 to 15 minutes. Strain and drink in 3 or 4 divided portions throughout the day.
Witch Hazel bark may be located at an herb shop, health food stores or found online using a search engine. Sources: Witch Hazel bark cs (cut and sifted) is available at www..herbco.com. For purposes of making a water or alcohol based extract, I would avoid buying the powder as you could end up with a paste. The cut bark is preferred for ease of making an extract. The website is operated by Monterey Bay Spice Co. in Watsonville, CA. Ph 831-722-3400 You can also use a search engine to find other sources.
1. Indian Herbology of North America by Alma R Hutchens
2. Today’s Herbal Health by Louise Tenny M.H.
3. The Herb Book by John Lust
4. WebMD. Com
5. Pubmed.com (National Library of Medicine)
Sunshine and black seed for HIV - a case report
(M.Z. a member of the email group shares results - name withheld)
Hello friends, I started my black seed (capsules) around beginning of May 2015. Initially I was taking 3 capsules twice daily but in June I increased to 5 capsules twice daily. I am also taking Neem Leaf and I just finished Transfer Factor. As I told you I also did biomagnetic sessions (9 of them, around one weekly). I am in Florida and I go out in the sun daily.
As I promised my test results: 15 May 2015 viral load: 15,046 copies/ml CD4: 593 CD8: 813 CD4/CD8 ratio : 0.73 White Blood Cells: 4,200 Platelets: 252 20 Jul 2015 viral load: 6,800 copies/ml CD4: 691 CD8: 922 CD4/CD8 ratio: 0.75 While Blood Cells: 5,500 Platelets: 304
Let us keep our faith strong because the cure is close. I have not taken ARVs yet. I think under normal circumstances the viral load should have gone up. I have been very depressed because of personal issues and I think my results would have been far more better had I been calm and happy. I would like your feedback. Thank you. (M. Z.)
My comment to M.Z. that were forwarded to the email group:
"The results you achieved are rare for someone not using prescribed HIV meds - your CD4 went up and your viral load went down. I wish I knew how the amount of time you spent outdoors in the sun increased your serum vitamin D levels. Any plans to test vitamin D levels in the near future? Your results support my theory that an effective black seed treatment for HIV also requires the component of adequate levels of vitamin D in the blood. We need to chart blood levels of vitamin D with the rise or fall of CD4 counts and viral loads. It is too early to draw general conclusions from your case but it keeps our hopes alive for the future. Conrad."
What are the normal reference ranges for vitamin D?
Answer - 30 to 100 ng/ml are normal reference ranges for serum levels of vitamin D. Based on published studies, the bottom of the reference range is 1 ng/ml. Published studies on the upper safe limit of vitamin D in the blood are 100 ng/ml according to Dr Michael Holick MD who stated that up to 100 ng/ml have been reported to be safe.
Dr. Holick states an ideal target range for blood serum is 40 to 60 ng/ml. Dr. Holick discusses the role of vitamin D in a full text article on Pubmed titled - Vitamin D - a D-lightful Solution for Health. I urge everyone to read this article. Dr Holick is the author of two books on Vitamin D - "THE VITAMIN D SOLUTION" and "THE UV EFFECT."
Several published estimates are that over 50% of the world's population are deficient in vitamin D and most of the people with the health conditions listed above are in the tank with severely low levels of vitamin D, some even in the teens and single digits.
The anti-sun propagandist with their scare tactics have damaged or diminished the health of millions of Americans for several decades. The only real beneficiaries are the big drug companies who will have a bigger market of sick people to sell drugs to.
Test Kits for Vitamin D are available from Life Extension Foundation The Life Extension Foundation offers a home test kit for vitamin D. It is Item # LC081950 or the Vitamin D Hydroxy 25 Blood Test. The foundations website is lifeextension.com. The cost is $62.67. You can order a test kit by calling 1-800-208-3444. They provide instructions on where to go locally to have blood sample drawn for the test. The kits are not available in Maryland.
Note: Life Extension Foundation recommends taking 5000 i.u. of vitamin D 3 daily for one month before taking the test. They state that 50 ng/ml for vitamin D blood serum levels is an ideal target goal. Note: A few people are now taking 10,000 i.u. daily of Vitamin D along with Black Seed powder for their health conditions. I am convinced that Black Seed powder alone [even with honey added] won't do its magic if Vitamin D levels are low (below 30 ng/ml). It will take some time for results of this combination protocol to trickle in, so keep your hopes alive and your powder dry.
Betulinic Acid from White Birch Bark kills Melanoma cancer cells
Clin Cancer Res. 2003 Jul;9(7):2866-75. Betulinic acid-induced programmed cell death in human melanoma cells involves mitogen-activated protein kinase activation. Tan Y1, Yu R, Pezzuto JM. The following are excerpts from this Abstract -
"Abstract Betulinic acid, a naturally occurring triterpene found in the bark of the white birch tree, has been demonstrated to induce programmed cell death with melanoma and certain neuroectodermal tumor cells. “We demonstrate currently that treatment of cultured UISO-Mel-1 (human melanoma cells) with Betulinic acid leads to the activation of p38 and stress activated protein kinase…. As demonstrated previously, cells treated with Betulinic acid generate ROS. Preincubation of cells with antioxidants blocks the process of programmed cell death, and prevents the phosphorylation of p38 and stress activated protein kinase/c-Jun NH(2)-terminal kinase."
Supplement Sources - Betulinic acid comes from the Chaga mushroom that grows on wild white birch trees. It is becoming increasingly popular as an anticancer treatment for melanoma. A search on the Internet will reveal several sources. North American Herb and Spice Co has wild crafted Chaga mushroom powder from White Birch trees. They state: "Chaga mushroom contains many beneficial active compounds such as sterols, polyphenols, betulin, and betulinic acid, the benefits of which are well published." A synergistic trio: Chaga mushrooms with betulinic acid, Vitamin D3 and Black Seed powder.
Note: Being that it is a natural product and is not patentable, it will never be approved by the FDA as the law requires a [synthetic] patentable compound. To treat a disease such as cancer with Chaga, see a health care professional knowledgeable in herbal medicine. Research shows that high doses of anti-oxidants (vitamin C etc.) will cancel the benefits of Chaga that release ROS (Radical Oxygen Species] to kill the cancer cells.
August, 2015 FDA vs. LeBeau update
As I reported in my last newsletter, after waiting 2 plus years for a decision from Federal Judge Charles Clevert, he set the date of July 21 at 3 pm for oral arguments in the case of 10-CR-00253. (For a reading of all 115 documents filed in this case since 2010, go to pacer.gov and enter the case number) The hearing was held in Room 222 at the Federal Courthouse 517 E Wisconsin Ave, Milwaukee, Wisconsin.
In preparation for the July 21st court hearing, I prepared and filed a list of 24 questions for the government to answer at the July 21st hearing. I filed this on July 9 2015. The questions were in the form of request for admissions coupled with a request for an explanation if they did not agree with the question. I truly believe that if the government had answered the questions honestly, they would have to admit that they were wrong on the issues of law I raised.
However, on July 18, U.S. Attorney Gordon Giampietro wrote a letter to Judge Clevert that the government would not answer any of the questions I posed for them. This refusal to address my questions and start a real debate did not surprise me. I then prepared a 10 to 15 minute statement to present to the judge and outline the most important issues in this case.
They were the Doctrine of Impossibility (based on the patent requirements of a non-patentable product Perfect Colon Formula). Also, the Doctrine of Overbreadth (FDA and DOJ attorneys who stretched the definition of drug from the 1906 Pure food Act to include food and water) and several violations of the U.S. Constitution including freedom of the press (labeling the intended use of a product) and unconstitutional restraint of trade that favored the owners of patented drugs.
At the July 21st hearing, the oral arguments I prepared for were canceled. Instead, judge Clevert asked me what were the most important issues for him to rule on. I cited the most important issues per the above paragraph. At this point, the U.S. Attorney suggested that the judge allow me to write a short brief and summarize the most important issues. I agreed. I asked for one week to write this brief. The government asked for two weeks to reply and I asked for one week to respond.
Now all the briefs are in and Judge Clevert’s decision is awaited. A lot is at stake in this case. If the FDA loses, it could end the power of the FDA to classify foods and dietary supplements as drugs based on their intended use to prevent or mitigate disease providing the case is upheld on appeal. The Dept. of Justice (DOJ) will no longer be able to bring civil or criminal actions against defendants who make truthful health claims without prior FDA approval. FDA actions against health claims would have to be through the Dietary Health Supplement and Education Act of 1994 where the burden of proof is on them, not the defendant. To read all 5 recent briefs go to the Forum link in the right column and then to #18.
Further action in this case will likely occur one way or the other before the end of 2015. An appeal to the 7th circuit in Chicago will likely be filed by either or both parties to this case. For public reading access, all the briefs cited in this article have been posted under the “Forum” link (right green column) on our website at keephopealive.org on or before October 5th. To order reprints of this newsletter - send $5 for 1 copy or $10 for 4 copies to. Keep Hope Alive, PO Box 270041, West Allis, WI 53227 414-two three one-9817 Visit keephopealive.org for bimonthly updates.
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