New 3rd edition Immune Restoration Handbook is ready.
GMO corn damages the kidney and liver of lab rats.
Fr. Romano Zago's aloe and honey "cure" for cancer
After being sold out of the 2nd edition of the IRH for the past 2 years, I finally finished revising the third edition. It would have been finished earlier this year were it not for my ongoing legal battle I have had with the FDA that has consumed hundreds of hours of my time. An updated report on this case can be found at the end of this newsletter.
The new edition will be "perfect bound" with a soft colored cover. The inside contains 270 pages 8.5 x 11 inches printed on 60 lb acid free paper.
Every section, chapter, website, phone number and statement has been reviewed and modified as needed. I also checked the current status of all resources listed, and deleted, updated or revised them as needed.
Carefully selected excerpts from the last 7 years of this journal were added to the book. The chapters on cancer and HIV have been substantially revised. An updated evaluation of all current (2011) FDA approved drugs used for treating AIDS is included in this revised edition. Information has been concentrated and reorganized. Four new chapters have been added. One on Glutathione, its power to turn on cell-mediated immune responses, fights infections from HIV to HBV. Several scientific abstracts are quoted that discuss research on how to increase this vital anti-oxidant in the body. Another chapter is on Hepatitis, one on Environmental and Electromagnetic pollution, and on Case Reports.
The new edition will be ready to ship out by Thanksgiving. See the enclosed Order Form. I want to thank everyone for their support and patience.
Black Salve gets rid of two tumors in my elderly dog.
In October 1998, I bought a two-month-old puppy from a homeowner in Franklin, WI. The black and white dog is a Fox Terrier. A friend who was staying with me at the time named him "Cosca."
Today, at 13 years of age, Cosca would be (in human years) over 90 years old. A high percentage of dogs (cats too) over the age of 10 years develop cancer. My own theory is that the pet food or table food is to blame. Most dog foods contain genetically modified corn. Corn is, in fact, not a stable of a wild dog. Corn is for the birds, not dogs. Researchers have found that genetically modified corn can cause kidney and liver malfunction in experimental animals.
For the last two years, Cosca has had a tendency to grow tumors. First, one grew on the underside of his belly, then one on his hindleg and a small one on his nose. About 6 months ago, I tied off the one on his belly with a thread to cut off the flow of blood to the tumor. It worked. About 3 weeks later it dried up and fell off. It did not re-grow back.
I switched to a non-corn dog food and alternated that with canned salmon and cooked vegetables. That seemed to help. New tumors stopped appearing, but the old ones still remained. This past October, I decided to try some experiments. I found an old bottle of "Black Salve" that is a remedy for skin cancer. It contains bloodroot. It is a thick black paste. Normally, you would apply a thin layer of Black Salve on a tumor and let it set for several days while it eats a hole in the cancer or tumor.
When I applied Black Salve to the quarter sized growth on the dog's hind leg, it kind of sat there and did not do much. After a few days, I decided to thin it out and applied some 80 proof alcohol to the tumor. The alcohol caused the Black salve to spread out and the tumor to absorb it. I repeated this 3 times and spaced these treatments about 2 days apart. About one week went by, and the tumor turned completely black and very hard like a stone. When I squeezed it, my first thought was that this is a dead tumor. I was right. In a few days it fell off. Since then the spot where the tumor had been attached to the dog's leg healed up completely.
The dog had one more tumor. This one was on his nose and is about the size of a dime. I made a mixture of one-half teaspoon Black Salve and one teaspoon of 80 proof Gin and placed it in a small jar. I applied it to the tumor according to the following schedule.
I used a Q-tip for all applications. On day one, the Black salve and alcohol mixture was applied. On day two, I applied pure castor oil to the tumor. On day three, I applied 3% hydrogen peroxide to the tumor. On days 4, 5 and 6, I repeated the cycle I used on days 1, 2 and 3. I continued this daily rotation of treatments until the tumor shrank to a small hard cyst. That took about two weeks. I expect it to fall off or disappear any day now.
Note: About 15 years ago a reader from Brooklyn, NY used Castor oil to treat a tumor on a cat and after one month, it shrank and disappeared.
I am also giving my dog one Brazil nut daily as a source of natural selenium. Selenium is very important in both preventing and treating cancer.
I think adding the alcohol to the Black Salve was an important discovery as the alcohol drew the Black Salve into the tumor and helped to destroy it more quickly. Adding a small amount of alcohol to other cancer treatments might just increase their effectiveness, as the alcohol acts like a delivery agent to get that cancer fighting ingredients into the tumor cells. Black Salve is sold in some health food stores. Black Salve won't come with instructions as "FDA minders" censor all information on how to use herbal formulas for treating any disease.
[Note: I would not use Black Salve internally for either pets or people - there are safer alternatives like Essiac tea (Ojibwa Indian tea formula) and the Gerson Diet program]
As for the diet, Purina has just come out with a dog food that is both free of corn and wheat. It is called "One Beyond." My dog tolerates it well. I rotate this with cooked vegetables mixed with brown rice and canned Alaska salmon. I sprinkle some probiotics on his food as well. For a natural dewormer, I cut up a clove of raw garlic and add it to his food once a week.
FDA officials sleep while Monsanto's genetically modified Bt corn causes kidney and liver toxicity
In 2007, Seralini GE et al in Paris, France, done an analysis of a 90-day rat feeding study using Bt corn called transgenic corn MON863 from Monsanto Corporation. Seralini states:
"This necessitated a new assessment of kidney pathological findingsŠ. Chemistry measurements reveal signs of hepatorenal toxicity, marked also by differential sensitivities in males and females. Triglycerides increased by 24-40% in females (either at week 14, dose 11% or at week 5, dose 33%, respectively); urine phosphorus and sodium excretions diminished in males by 31-35% (week 14, dose 33%) for the most important results significantly linked to the treatment in comparison to seven diets tested. (1)
In 2009 a study done by E Vendomois JS et al in Paris studied the effects of 3 types of Monsanto corn - NK 603, MON 810, and MON 863 on corn fed rats. Their analysis revealed for the 3 GMOs new side effects linked with GM corn consumption, which were sex and dose-dependent.
The adverse effects mostly involved the kidney and liver, that are the major detoxifying organs of the body. Vendomois reported, "Other effects were also noticed in the heart, adrenal glands, spleen and haematopoietic system. We conclude that these data highlight signs of hepatorenal toxicity, possibly due to the new pesticides specific to each GM corn." (2)
The widespread use of genetically modified corn in pet food could explain the large number of household pets that have kidney failure in their later years. However, because the FDA is more interested in protecting the bottom line of Monsanto Corporation than the health of the American people, GMO corn is also being consumed by the public without a word mentioned on the label. These GMO products are just as likely to cause liver and kidney damage in humans as they have to laboratory rats. The failure of the FDA to protect the public is just plain criminal behavior.
Note: For more info go to seedsofdeception.com
1. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. By Séralini GE et al, Arch Environ Contam Toxicol. 2007 May;52(4):596-602. Mar 13.
2. A comparison of the effects of three GM corn varieties. bde Vendômois JS, et al, Int J Biol Sci. 2009 Dec 10;5(7):706-26.
"Cancer Can be Cured" - Fr. Romano Zago OFM
A few years ago, in 2007 or 2008, I talked with someone who called and told me about Father Romano Zago's raw honey and aloe treatment for cancer. The person told me that many people had been cured of cancer using this formula. I jotted the information down including a website, and placed it aside to look at it at a later date.
In 2010, as I was revising a home remedies book I wrote on hydrogen peroxide and ozone with a new title "Hydrogen Peroxide and Aloe Vera plus Other Home Remedies," I included Fr Zago's raw aloe and honey recipe along with several other low cost cancer treatments. At the time I obtained a used copy of Fr Zago's book "Cancer can be Cured" at amazon.com used bookstore.
Fr Zago was born in Lajeado, Brazil on Aug 11, 1932. He was ordained a Franciscan Friar in 1958. In 1988 while presiding at the San Antonio parish in Pouso Novo (RS) Brazil, he learned from local natives a potent all natural recipe made from Aloe Arborescens for curing cancer and other diseases.
A few years later, he went on to new assignments in Jerusalem and in Italy where he seen success using this formula on the chronically ill. Fr Zago states he did not originate the formula. He learned about it from natives and poor people who over time, trial and error, discovered how to make their own medicines.
In his book he writes. "this recipe is inexpensive with no contraindications or negative side effects, targeted at alleviating the suffering of the sick and those directly or indirectly connected to them, who are sometimes helpless when faced with the enormity of the problem."
In his book, Fr Zago reports on 39 individual cases of cancer, many terminal, that were cured with aloe and honey. Excerpts from his book describing the recipe can be found at aloearborescens.org.
In his book, he describes the joy of receiving a phone call about a girl with lupus who was cured after using the honey and aloe treatment for just 3 weeks.
There are many species of aloe plants. Fr Zago uses aloe arborescens. However, in North America, aloe arborescens is difficult to find. Aloe Vera Barbadensis is the most common form of aloe used and is available in many aloe products from aloe vera juice to gels and lotions. Research published at the United States National Library of Medicine on aloe vera barbadensis indicates this species has anti-cancer properties.
Aloe Vera and AIDS
In his book, Fr Zago discusses the use of aloe vera in treating AIDS. He reports on several cases where CD4 counts increased significantly and of the disappearance of symptoms and a return to normal life. He states that Dr Cristina Sannia of Cagliari, Sardinia in Italy treated 3000 people with AIDS using the honey and aloe formula. The doctor reports that after taking 3 jarfuls, her patients have better appetite, healthy skin color, and the liver is restored to a good condition.
However, Fr Zago says that while the honey and aloe treatment actually cures cancer, it does not cure AIDS, but it does prevent further progression. It reverses and eliminates symptoms and restores normal immune function by increasing white blood cell counts and CD4 counts.
With AIDS as with cancer, Fr Zago recommends a meatless diet composed of vegetables, seeds, nuts and whole grains. Apples are also highly recommended. In his book, Fr Zago tells of a Rabbi in Israel that advises people with cancer to go on a diet and eat nothing but apples until the cancer is gone. Interestingly, organic apple along with carrot juice are a mainstay of the Gerson Therapy that has been in use for more than 60 years to treat and cure cancer.
The amount of aloe vera used is surprisingly small - less than 2 ounces daily. Fr Zago used a species called aloe arborescens. The plant is native to Brazil and countries in the Mediterranean area. There are over 300 species of aloe.
How to prepare the aloe and honey plus alcohol mixture
- Eight ounces of raw bee's honey
- One tablespoon of liquid Grappa, Cognac, Brandy or Whisky.
- 200 grams (about 7 ounces) of Aloe Arborescens or Aloe Vera leaves. (The older and larger leaves are preferred)
How is it prepared?
Father Romano says: "Take (remove) the thorns from the sides of the leaves and the powder deposited (on the leaves), making use of a dry cloth or a sponge. Cut the leaves in pieces (without removing the skin) and put these in the liquidizer (blender) or together with the honey and the chosen distilled liquid. Liquidize well the mixture and it is ready to be consumed. The mixture is not to be filtered, nor heated but simply well conserved in the refrigerator inside a dark jar which would have been firmly closed."
(Editor's suggestion: I would use up each batch within 10 days, take 5 days off and then make a new batch and start over. In the United States, it is nearly impossible to find the Arborescens species. It is better to buy a product made according to specifications than to save a few dollars and not get results.)
The dosage advised by the Fr Zago is of a tablespoon of the mixture half an hour before every one of the three main meals. The mixture should be shaken before being used. Once the first jar is finished, it is advisable to undergo a medical check-up to understand what stage the illness has reached. Based on the doctor's feedback and following a few days of break, one can repeat the cycle of cure, until the complete elimination of the cancerous elements is achieved. The mixture is usually taken for 10 days followed by 5 days off and then repeated again 10 on 5 off until the cancer or other illness is gone.
The aloe leaves should come from a mature plant, preferably four years old or older. It is important that honey is of excellent quality and above all raw, because of its characteristic as a carrier of beneficial substances contained in the aloe. As regards side effects as a result of aloe, Fr. Romano Zago points out that the latter should not frighten anyone. They represent in fact the expulsion, the complete liberation on the part of the organism of impure substances, and above all, when verified, have a limited duration of one to three days maximum.
Those who take the aloe-based drink can thus experience skin rashes, diarrhea or, in more serious cases, vomiting; but above all, according to Fr. Romano Zago, this indicates that one is on the road to recovery and that the efforts made will start reaping fruits.
Since Aloe Vera has a cooling effect on the body, its use for inflammatory condition and over heating in areas of the body may be beneficial. Persons with autoimmune conditions, acid reflux, colitis, ulcers, cancer, autism, lupus, multiple sclerosis and nerve damage may all benefit from the internal use of small amounts of aloe vera. Externally, many other conditions should benefit including rashes, herpes, shingles, burns, radiation burns and sunburn.
Besides cancer, other conditions that Father Romano Zago's Aloe Vera formula has benefited as reported at the Italian website- aloedipadreromanozago.it/eng
Conditions treated by the aloe and honey combo
- Acidity in the stomach,
- Lupus, persistent acne,
- Parkinson's disease,
- normalizes cholesterol levels,
- sexual aid for persons over-forty,
- small scars on scalp,
- bad breath,
- athlete's foot,
- skin rashes,
- intestinal polyp,
- uterine polyp,
- callosity, prostate,
- hair loss,
- high or low blood pressure,
- bad digestion,
- appetite stimulator,
- skin furuncles,
- retina ulcer,
- varicose ulcers,
- nail atrophy
Resource USA: Quantum Nutrition Labs, Austin TX makes Fr Zago's formula. Sold as "Aloe Arborescens" in 16 oz bottle to health food stores and practitioners. One U.S. source is aloeproductscenter.com
Scientific research on the health benefits of aloe vera
Sep. 13, 2010. Scientists report that Aloe Vera and honey combination reduces tumor mass and metastases
An article published in Phytotherapy Research gives credence to the raw honey and aloe treatment for cancer, but the abstract makes no mention of the Arborescens species of aloe being used. The term "aloe vera" generally is used to refer to the barbadensis species that is common to North America. Tomasin R. et al report from their experiments on Wistar rats fed aloe vera and honey that "Aloe vera may reduce tumor mass and metastasis rates, while honey may inhibit tumor growth." (1)
This study determined the effects of Aloe Vera and honey on tumor growth, size and the cell growth rate. Testing was done at 7, 14 and 20 days after Walker 256 carcinoma implant in Wistar rats. The Wistar rats were divided into two groups, one receiving the honey and aloe vera mixture and the other was on a saline solution.
"The effect of Aloe Vera and honey against tumor growth was observed through a decrease in relative weight (%) and Ki67-LI in tumors from the WA group compared with those from the CW group. The Bax/Bcl-2 ratio increased in tumors from the WA group at all tested time points. These data suggest Aloe Vera and honey can modulate tumor growth by reducing cell proliferation and increasing apoptosis susceptibility." (1)
Check with your health food stores for raw honey and fresh Aloe Vera leaves or stores that import fresh food items from Mexico and other foreign countries where aloe is grown. (Aloe leaves should be 18 inches or longer in length - do not use small leaves from a potted plant.) Fr Zago's formula is also commercially made in Brazil, Italy and other countries.
1. Oral administration of Aloe Vera and honey reduces walker tumor growth by decreasing cell proliferation and increasing apoptosis in tumor tissue. Tomasin R, Cintra Gomes-Marcondes MC. Phytother Res. 2010 Sep 13; Laboratory of Nutrition and Cancer, Department of Anatomy, Cell Biology and Physiology and Biophysics, Institute of Biology, State University of Campinas -UNICAMP, Campinas, 13083970, São Paulo, Brazil.
Who should limit their use of aloe?
Pregnant women and children under one year of age should not use the aloe/honey mixture. Persons who have a very alkaline saliva (over 7.0) and urine pH (over 7.0) such as (strict vegetarians, using high doses of COQ10, limewater, magnesium hydroxide, germanium, ozone or H2O2?) or who have difficulty digesting protein and are low in hydrochloric acid should limit their use aloe vera internally to shorter periods of time and use it in small amounts. External use of aloe vera products should not matter here.
Persons who are alkaline, with poor digestion of protein and who are generally cold need thyroid support and liver detoxification. Consider using cayenne, ginger, turmeric, cinnamon, wakame, kelp, dulse, brewers yeast or other sources of natural B vitamins, whole grains. legumes and seaweed. Also fermented or sour foods like sauerkraut, real buttermilk, lemon or limejuice, vinegar, organic pickles and the daily use of probiotics to increase the internal production of B vitamins in the large intestines.
Scientific Research on Aloe Vera - Cardio protective and anti-oxidant
In India, researchers experimented on rats and gave them a single dose of doxorubicin (DOX) that induced oxidative stress. When they gave 100 to 200 mg of aloe vera gel per kg (2.2 lbs) for 10 days, it provided significant anti-oxidant protection and increased glutathione levels. The use of aloe vera gel "orally for 10 days produced a significant protection against cardiotoxicity induced by DOX evidenced by significant reductions in serum LDH, serum CPK, cardiac lipid peroxides, tissue catalase and tissue SOD along with increased levels of blood and tissue GSH." (1)
The decrease in lipid peroxides and the increase in the anti-oxidant GSH (glutathione) in the tissues bodes well for many other health conditions where oxidative stress causes damage to cells. Aloe vera can have a protective role in reducing oxidative stress on the heart, liver, eyes and skin. What is amazing is just how small an amount of aloe vera was needed for this protection. The equivalent in a person weighting 150 lbs would be just one tablespoon daily of Fr Romano Zago's aloe/honey mixture assuming the ratio of aloe vera to honey is about half and half.
1. Effect of aloe vera (Aloe barbadensis Miller) gel on doxorubicin-induced myocardial oxidative stress and calcium overload in albino rats. Kaithwas G, Dubey K, Pillai KK. Indian J Exp Biol. 2011 Apr;49(4):260-8.
Research in Brazil for plants with anti-tumor effects
Researchers in Brazil (Melo, Santos, Amorim et al) studied papers published between 1980 and 2008 on the use of plants and herbs used by traditional healers in rural communities for their anti-cancer effects. 84 medicinal plants were used for their cancer preventive or curative effects. They report that "the plants that were cited at a higher frequency were Aloe vera, Euphorbia tirucalli, and Tabebuia impetiginosa." They added "a majority of the studies selected were conducted in rural communities and urban areas and in areas with traditional healers in Brazil." (2)
2. Medicinal plants used as antitumor agents in Brazil: an ethnobotanical approach. de Melo JG, Santos AG, de Amorim EL, do Nascimento SC, de Albuquerque UP. Evid Based Complement Alternat Med. 2011:365359.
Research on Aloe Vera for colitis, improving insulin sensitivity; type 2 diabetes and metabolic syndrome
Researchers in Korea studied the effects of aloe vera on colitis that was chemically induced in rats. The results of the experiment showed the anti-inflammatory effects of aloe or aloe components including aloin and aloesin. Inflammatory cytokines including leukotrienes and tumor necrosis factor-a were reduced substantially in the rats given the aloe treatment. They report, "Colonic mucosa TNF-_ and interleukin-1ß (IL-1_) mRNA expressions were significantly reduced in all animals fed aloin, aloesin, or aloe-gel." (3)
3. Dietary aloin, aloesin, or aloe-gel exerts anti-inflammatory activity in a rat colitis model. Park MY, Kwon HJ, Sung MK. Life Sci. 2011 Mar 14;88(11-12):486-92.
Aloe vera may help in insulin resistance, obesity and type 2 diabetes. At the University of Seoul in South Korea, researchers studied obese mice on a high fat diet for 54 days. The obese mice fed a high fat diet were supplemented with aloe. Another group of obese mice acted as controls with no aloe supplementation. Testing was done for inflammatory markers.
The results were that the mice supplemented with aloe had lower glucose and insulin levels. Several inflammatory markers were reduced including triglycerides, tnf-a, il-1b, il-6 and il-12.
The authors concluded "Dietary aloe formula reduces obesity-induced glucose tolerance not only by suppressing inflammatory responses but also by inducing anti-inflammatory cytokines in the WAT and liver, both of which are important peripheral tissues affecting insulin resistanceŠ..its use as a nutritional intervention against T2D and obesity-related inflammation is suggested." (4)
4. Dietary Aloe Improves Insulin Sensitivity via the Suppression of Obesity-induced Inflammation in Obese Mice. by Shin E, Shim KS, Kong H, Lee S, Shin S, Kwon J, Jo TH, Park YI, Lee CK et al. Immune Netw. 2011 Feb;11(1):59-67. Univera Inc., Seoul 133-120, Korea.
Aloe Vera and honey recipe
Unable to find Aloe Arborescens locally, I used an aloe vera leaf that I purchased from a local Mexican grocery store. Fr Zago stated that the plants older plants are more beneficial than the younger ones. Still many of the components in the younger aloe plants are identical to those found in the older plants. I made one batch according to Fr Zago's formula but found it too sweet for my taste, so I made a new batch and used more Aloe than honey. I used 4 ounces of aloe vera leaves (common to North America) to 3 ounces of raw honey. I added one tablespoon (one-half ounce) of Brandy. Place all ingredients in a blender and blend for about 30 seconds. Store in a refrigerator and out of sunlight.
I washed the leaves and removed the spines along the edge of the leaf but left the green skin on. I placed the Aloe in a blender and turned it on for a few seconds then added the raw honey. I kept the resulting mixture in a glass jar in the refrigerator. At one tablespoon 3 times a day, this would last about 5 days. I suggest making a small fresh batch every 5 to 7 days. Small batches are likely to have more therapeutic value as they are less exposed to light and oxygen that would lessen the therapeutic properties of the mixture. A large aloe leaf can be kept in the refrigerator for up to 30 days and cut up in small pieces when a new batch is made.
What role does the alcohol have in the formula
After seeing the success of destroying a tumor on my dog by using 80 proof Gin along with the Black Salve, I think the alcohol acted to deliver the medicinal properties of the Black Salve into the tumor or cancer cells. A small amount of alcohol could help deliver the Aloe constituents in the same way - into the cancer cells to destroy them.
April to Nov 2011 - notes on my legal battle with the FDA
by Conrad LeBeau
April 15th Status hearing. Fed Defender Brian Mullins asks the judge for 3 weeks to file the motion to dismiss. Judge grants the request. The Motion to Dismiss is due by May 6th.
Atty Mullins likes my brief and says he will tweak it. I continued to work on the motion and brief but was unable to meet with Brian Mullins until the very day the brief and motion was due. I was shocked that he decided to write his own motion and only use some ideas from mine. Brian writes to the judge and asked for the weekend to finish his work on the brief. Attorney Mullins filed a short 15 page brief on Monday May 9th.After reading it I had no confidence that this brief would get the case dismissed.
May 11, 2011 At this point, I decided I needed to dismiss my attorney and take charge of my own case. I sent a letter to US Atty Gordon Giampietro proposing to waive my jury trial rights if the FDA drops charges against Vital Health Products LTD. I did this to get the obligation of finding an attorney for the corporation off my back. Gordon rejects my proposal.
May 19th I filed a request with the court to be allowed to represent myself and I filed a motion for leave of court to file a supplementary and amended Motion to Dismiss.
Saturday May 21 - woke up at 3 am - dreamt I missed my court appointment for Monday morning at 9:30 am by oversleeping. Could not get back to sleep
Sunday May 22 - slept to 5 am Monday morning.
May 23rd 9:30 am. I asked the judge to dismiss the Federal defender and that I be allowed to represent myself. Judge asked me who would represent Vital Health Products, a corporation. I told him no one. The judge said the corporation must have representation. I told the judge the corporation was dissolved in August 2010 and has no assets.. I asked to have until the end of the week, Friday, May 27th to file my Motion to Dismiss with the Brief.
I told the judge I would look for outside counsel to represent the corporation. The judge then allows me to represent myself.
May 26th 3 pm - My Motion to Dismiss with 71 page brief is finally filed along with 200 pages of exhibits and 2 copies of Attorney Jonathan Emord's book on "The Rise of Tyranny."
May 31th, Atty Gordon Giampietro writes a letter to Judge Callahan asking him to order me to find an attorney to represent Vital Health Products citing local Court rules.
I responded with a Memorandum opposing his letter and cited a court case where the sole owner of a corporation was allowed to represent not only himself but his corporation as well because he was the only stockholder. I asked the judge to give me two weeks after he rules on my Motion to Dismiss to allow me find an attorney for Vital Health Products Ltd.
June 8th - Judge Callahan rules against US Attorney Gordon Giampietro's request and Orders the corporation to find its own attorney. This relieved me of any and all financially responsibility to look for funds to find a lawyer to represent the corporation. The Judge gave me more than I asked for.
June 24th - the FDA replies to my Motion to Dismiss with their 23 page brief.
July 15th - I file my response to the FDA's brief of June 24 with a 29 page brief.
Sept 21 - Judge Callahan denies my Motion to Dismiss in a nine page Decision and Order. It was a major disappointment considering all the work that had gone into the Brief. The Judge said I was raising issues that should be addressed to Congress. He then quotes cases cited by FDA attorneys on the definition of "drug" and "new drug" that said First Amendment rights of the press were not violated by the law defining what is a "new drug." In fact, most of the legal arguments I raised in my lengthy brief were not addressed by the judge including the patent issue and that the composition of a "new drug" needs to be "new," and have a new material composition and not just a "new intended use."
Sept 26th. Pursuant to Rule 12-C (A) of the Federal rules, I filed a Request for Leave of Court to file a "Motion and Notice of a Procedural Defect by the US Food and Drug Administration before the prosecution was initiated, and of FDA failure to respond to my FOIA request."
A third cause of action not cited in the above caption was included. It was to dismiss the case due to a defect on paragraph 11 of page 4 of the "Information" (Indictment) that states the defendant did not file a New Drug Application (NDA). I alleged that paragraph 11 is misleading as it implies that the defendant had a "remedy at law" and could have filed a NDA to obtain FDA approval for the health information he provided on his products. In this 3rd cause of action to dismiss the case, I showed the Court where federal laws and the Code of Federal Regulations require a patent number to file a New Drug Application (NDA). I then state the fact that since dietary supplements are not patentable, there is no remedy at law for the defendant. Thus, no NDA could be filed let alone approved and this runs up against the "Doctrine of Legal Impossibility."
A second cause to dismiss the case is the "Doctrine of Economic Impossibility" in which I state that since the products are not patentable, there is no exclusive marketing rights the FDA and Patent office could confer on the defendant's products, and millions of dollars spent to obtain FDA approval would not be recoverable during the lifetime of the defendant.
Sept 28th - 9 am. A status hearing is held. I arrived with a headache, a sore neck and the outbreak of a serious head and chest cold. The judge arrives 15 minutes while he reads my motion in the Chambers. The judge asks US Atty Giampietro if he wants to answer my motion. He says he does and asked for one week. I asked for one additional week to reply to his answer. The judge sets a pretrial date for Nov 30th, 2011 and a tentative trial by jury date of Dec 5th 2011.
October 6th - A FDA memorandum opposing my latest motion is filed and a copy arrives by mail on Oct 8th.
October 11th - I file a new shortened Freedom of Information Act request with the FDA seeking files and evidentiary material that would help me at the trial.
October 11th - US Atty Giampietro writes to the judge and asks that the trial date be set after Jan 1 2012 due to a scheduling conflict. I agreed to this in a phone call to Secretary Brenda, who works in the Judge Callahan's Chambers.
October 12th - I filed my response to the FDA Memorandum of October 6th.
Oct 25th, 2011. I sent the following letter to Judge William E Callahan, Milwaukee, WI
"After filing my reply to the government's response to my last motion, which I did on Oct 12th, I discovered a "Guidance Document" on the FDA website (fda.gov) titled "NEW DRUG EVALUATION GUIDANCE DOCUMENT: REFUSAL TO FILE" It is dated July 12, 1993 and a copy of this 7 page document is attached.
This document cites several reasons why the FDA would refuse to accept a "New Drug Application." The most common reason being "incomplete information" required on the NDA form. Section I, the "INTRODUCTION" of this Guidance Document states that an NDA application must comply with Sec 314.50 or 314.94. Since Sec 314.50 (h) requires patent information, the NDA for a food, herb or dietary supplement, (the defendant's products) would be rejected as "incomplete." Thus, the remedy that the government suggested in paragraph 11, page 4 of the Information is both misleading and non-existent.
A copy of a NDA application is also enclosed. Note that the Patent information is required on page 2 of the application as item #13. Item #14, the Certification of "no relevant patent" is separate from the patent information required. Thus the FDA's argument that the "certification" statement is a substitute for the required patent information is not supported by the NDA application. This memo is a supplement to my reply of Oct 12th
Finally, defendant asks the Court to consider in the final argument under the 3rd issue of the motion "Doctrine of Economic Impossibility" not only that the defendant would never recover an investment for FDA approval of a non-patentable food or herbal supplement; but also whether the law as applied creates a monopoly for patented drugs that constitutes restraint of trade against foods, herbs and dietary supplements? This monopoly exists by "virtue" of suppressing the right of a distributor to provide the public with information on the health effects and benefits of foods and dietary supplements used on labels and in advertising. Whether this total suppression of information constitutes an illegal restraint of trade is an issue that should be considered by this Court. I thank you for your attention to these matters.
11/10/11. There is no reply yet from the judge on this latest motion. A pretrial is set for Nov 30, 2011 and a jury trial is currently set for Jan 25th 2012, 9 am, at the Federal Courthouse in Milwaukee, WI. Updated reports can be found at keephopealive.org or call 414-231-9817 days.
Reprints of this issue are available. 3 copies for $3.00; 5 copies for $4.50; 10 copies for $8.00 Keep Hope Alive PO Box 270041 West Allis WI 53227 Online at keephopealive.org 414-231-9817