A CLASSICAL EXAMPLE OF MEDICAL QUACKERY -Thyroid - Cancer

[Guest guest]

A CLASSICAL EXAMPLE OF MEDICAL QUACKERYhttp://www.duffyslaw.com/current2.htm21st CENTURY STYLE: THE NON SPECIFICITYOF "PROSTATE SPECIFIC" ANTIGENBy Daniel H Duffy Sr, DC Rewritten September 6, 2004On Saturday, June 15, 2002 a long time patient came in for his regular checkup and treatment via AK. He is now 77 and has been a patient for almost 30 years. He was preparing for a senior citizen race walking event. On a recent visit to His MD, he was examined in orthodox fashion and found to have an elevated PSA for which an incredibly expensive drug was prescribed. It cost over $1000 for 90 pills. Three of the pills immediately made him sick so he stopped taking the drug after his first three doses. Of course, he only paid five of the $1000 plus dollars it cost - we the taxpayers paid the rest - thanks to the socially disastrous efforts of LBJ - the father of MEDICARE.* [see short story at the end of the Prostate article]. HERE ARE THE FACTS ON PROSTATE SPECIFIC ANTIGEN, THE PSA NOTORIOUS PSA TEST WITH ITS DISASTROUS RESULTS, NOW CONFESSED BY ITS CHIEF PROTAGONIST DR STAMEY OF U OF CAL......PASS THEM AROUND!!! 1. PSA means Prostate Specific Antigen. 2. PSA is NOT specific and has LITTLE to do with the prostate specifically. 3. PSA is found in females with breast, lung and uterine cancers. [whoops!] In fact, the highest levels of PSA have been found in females RECOVERING from breast cancers. [J Nat'l Cancer Inst Oct 6, 1999, Fortier, AH et al] Surprise, surprise, the ladies that made the best recoveries were the ones with the highest PSA levels!! 4. PSA appears to be an anti-angiogenic molecule. For those of you unfamiliar with the term, one of the features of cancer is that it has an enormous appetite and therefore needs a huge blood supply to feed it, so wherever you see cancer growing, you will see angio-genesis taking place – the creation of new vascular tissue. [That's why shark cartilage became popular.] 5. PSA appears to inhibit the usual increases in circulation necessary to feed the cancer and to support its rapid growth and proliferation. 6. Nicholas Gonzalez MD of NYC reports patients who have shown PSA levels of a hundred or more for long periods of time who are doing just fine as they recover from their cancers - he opines that increased PSA levels indicates a GOOD response by the body, NOT a BAD response. [audio tapes 12 and 17 spring 1999 lecture, ACAM – see ordering info below]. Dr Gonzalez uses the nutritional protocol that he learned from his teacher, the orthodontist and scientist, Dr William Donald Kelley of Grapevine, Texas, who is one of my three nominees for the Nobel prize in medicine [along with George J Goodheart DC and James Pershing Isaacs MD]. Gonzalez also reports a well recovered cancer patient with a CEA of 350,000, the highest in medical history. See the article on this site entitled, The AMAS test, to learn about the CEA which is another cancer marker. When a tumor breaks down it dumps CEA into the blood stream which can be measured. WARNING AND CAUTION NOTE!! BE CAREFUL ABOUT WHAT YOU THINK ABOUT BLOOD TEST LEVELS AND TUMOR SIZES, MORE IS OFTEN NOT WORSE, AND BIGGER, [TUMOR], IS OFTEN NOT WORSE!!! The healing process often causes tumors to encapsulate and get a little bigger rather than smaller, although the growth is stopped and they are walled off!! 7. So giving a toxic drug for a "specific" antigen which is not at all "specific" is just one more in a long line of examples of medical quackery being propagated by present establishment sources. It’s sort of like giving a deadly drug for a non infectious, non transmissible disease [AIDS] allegedly caused by an unproved virus [HIV]. It can also be compared to injecting newborn babies with foreign proteins and heavy metal poisons to “protect” them from adult diseases found mainly in intravenous dope addicts [recreational drug users]. Note that I use the old familiar term for these human wastrels – “dope addicts” rather than “substance abusers” – dope addict is more apropos. Sort of like calling a bum a bum, rather than a homeless person. Using the euphemism “homeless person” might make you feel better but hey, life is not fair, some people are bums. Face it. Others are criminals. Face it. Not facing it results in what we’re discussing here. Highly educated people committing crimes against humanity and getting away with it largely because we indulge the use of politically correct language. If we were in the habit of calling bums what they are, and dope addicts what they are, we might not find it so difficult to call an MD a quack and a criminal and begin to take steps to put them where they belong, behind bars, not out on the street preying on the innocent and the ignorant. The very highly educated, brilliant doctor, Thomas Stamey published the original study on PSA in the New England Journal Of Medicine in 1987. He concluded, based upon his knowledge, experience and training along with the study result that the worse the Prostate cancer, the higher the PSA. Exactly the opposite is true! Dr Stamey is an honest fellow though, he recently was quoted as saying “I removed a couple of hundred prostates I wish I hadn’t.” [F.B.Dunn, J Natl Cancer Inst Vol 94, No6, pp 415-16 Mar 20, 2002] The activities of Dr Stamey raise several questions: 1. Do you think that Dr Stamey should be held accountable for those unnecessary surgeries? 2. What do you think would happen to the tobacco industry executives or the auto industry executives or the toy industry executives if they were caught killing, maiming or harming so many people – especially innocent children like those suffering from quack vaccine induced disabilities and death?3. Do you think the deaths of prostate cancer patients resulting from misdiagnosis and maltreatment became part of the statistics used to place the practice of orthodox medicine in third place on the list of causes of unnecessary deaths in the USA?4. Are you beginning to get the right idea about the dreadful effects orthodox medicine in the 21st century?5. Why is it that many people are serving prison sentences for shaken baby syndrome [many of whom are victims of medical misdiagnosis] and doctors are quick to charge lay people with neglect and abuse but we see no doctors serving time for the same reasons? Since 328 people are killed every day by orthodox medical activity, why do we not see a lot of doctors in jail? Isn’t it time we began holding them responsible in the same manner they hold lay people responsible? I'll say it once again, CONSENSUS-DRIVEN, ORTHODOX MEDICINE IS CRIMINAL BEHAVIOR, IT IS BAD FOR YOUR HEALTH AND IT IS THE ROOT SOURCE OF ALL OF THE MEDICAL QUACKERY OF THE 21st CENTURY. It is also the greatest threat to life and limb and health in all recorded history. Do you REALLY think that orthodox medicine is only number three in the cause of deaths in the USA? If you believe that I have a bridge to sell you! Most of the deaths caused by orthodox medical doctors go unreported and unrecognized for what they are. The reported figures are only the tiny tip of a very large iceberg. This underreporting is especially true of vaccine reactions. Especially in infants and young school aged children. And we want to trust these people and accept what they have to say about VACCINES and HRT [hormone replacement therapy] etc.??? We want to trust these consensus driven quacks to inject our neonates with poisons? We want to accept the dribble and gobbledook nonsense they continue to propagate about vaccines, phantom diseases, phantom viruses, bacteria and prions as the CAUSES rather than the RESULTS of most disease processes??? CRISIS MEDICINE, ON THE OTHER HAND, IS A BLESSING TO HUMANITY - IT WILL SAVE YOUR LIFE IN AN EMERGENCY, RESCUE YOU FROM CONGENITALLY INFLICTED PROBLEMS, AND SPARE YOU MOST OF THE UNNECESSARY PAIN AND SUFFERING FROM TRAUMA AND ACCIDENTS – don’t confuse one with the other, don’t throw the baby out with the bath water. WHAT TO DO IF YOU HAVE A SWOLLEN PROSTATE THAT INTERFERES WITH URINATION:Find a doctor who will teach you how to catheterize yourself. Catheterize yourself three times a day to prevent buildup of urine in the bladder. This has been reported to have successfully corrected an enlarged prostate recommended for surgery. Self catheterization gives the prostate a rest, allowing it to recover. Saw Palmetto taken on a daily basis helps the situation. Urine buildup in the bladder can be dangerous, be sure that your doctor monitors your progress. PASS THIS ON TO AS MANY PEOPLE AS POSSIBLE, ESPECIALLY YOUR LEGISLATORS. ORDER THE GONZALEZ AUDIO TAPES FROM: Anthony CrumProfessional Audio Recording4905 Marshall Creek Dr.La Verne CA 91750800-430-4727Dr. Gonzalez's talks are available from the ACAM Ft. Lauderdale meeting. Two tapes are available: a formal lecture tape # 12 and a workshop on a continuation of the same topic, tape # 17. The order code is 02-102, # 12 & 17. The cost is $11.00 ea. Total $22.00 plus $2.00 shipping, total $24.00. You can place the order by e-mail, fax, or by phone. Payment is by either credit card. Visa, Master Card, or AMEX. Or you may send a check to Anthony Crum made out to PAR.<!--[if !supportLineBreakNewLine]--><!--[endif]-->*Because of the biased reporting in the USA [polls reveal that 89% of journalists vote for the democrat party, all three major networks support the democrat party and continuously under report positive news and over report negative news of the Republican party, indicating that journalists as a group are liberal minded, Utopianists driven by their emotional, rather than their intellectual, brains.] As a result, the general public is unaware that the liberals proved themselves to be wrong about the effects of welfare and government support on the lives of the poor. This was demonstrated by the failure of the NIT [negative income tax] program - LBJ's pet project designed to demonstrate that welfare would work if handled properly. In the greatest social experiment in history two groups were examined: one group received welfare, one didn’t. It was called “the negative income tax program” – it backfired terribly. LBJ’s welfare program tore apart the negro and hispanic families in which divorce rates exceeded 80% in one of the groups. All of the statistics and complete explanation can be found in Murray's book, Losing Ground, published back in the early 80s. and totally ignored by the liberal establishment]. In the New Jersey experimental group, the government supported group showed a divorce rate increase of 66% amongst blacks and an amazing 84% increase amongst Hispanics!!! The divorce rate amongst whites remained unchanged. In the Gary, Indiana group there was no change in the divorce rate because they thought they would lose their welfare money if they split up. This controlled program demonstrated the effects of welfare and should have been widely publicized. It was not. It was stifled and suppressed by both government and liberal media journalists.Just as “the dog returns to its vomit”, so do emotionally driven, pseudo intellectual liberals, return to the socialist experiment which has failed miserably time after time after time throughout history. You can teach a man how to fish but once you begin giving him fish, he will never learn to fish for himself and he will then become an albatross around his neighbor’s neck. DHD Sr rewritten August 12, 2004 THE GREAT THYROID SCAMBy Daniel H Duffy DC NOTE: LUGOL’S SOLUTION IS AVAILABLE FROM THE GENEVA CHIROPRACTIC CLINIC – ONE OUNCE DROPPER BOTTLES, $10 EACH, FOUR BOTTLES WITH ANY SINGLE ORDER FOR $30, plus UPS charges. 440-466-1186. Isn’t it odd that the government dispenses Iodine to protect against radioactive Iodine resulting from a nuclear disaster when the medical quacks are dumping the same type of radioactive Iodine into patients with thyroid problems in a stupid attempt to “cure” thyroid “disease” caused by a lack of elemental Iodine in its natural state found in nature? Nature’s Iodine protects our thyroid glands from taking up biologically destructive, radioactive, Iodine, yet the medical quacks use similar radioactive Iodine to destroy our thyroid glands??!! [mainly in women]. Why did doctors quit using Lugol’s solution, the sure cure for thyroid disease? Why did the medical quacks bring in anti thyroid drugs and goitrogens to kill the thyroid gland when Iodine was being used so successfully for so long? Since Thyroid disease is caused by malnutrition or poisoning [as are most diseases – if you believe otherwise you need to read elsewhere on this site to relieve yourself of the “infectious” disease ideas you carry around in your head.], why is this malnourishment NOT addressed? How many doctors even know what the [totally inadequate] RDA for Iodine is, much less that it has never been established by proper studies? And how many doctors busily destroying female thyroids with quack anti thyroid remedies know that the Japanese mainlander consumes a hundred times more Iodine than the American citizen while enjoying the lowest cancer rate of all cancers except stomach and almost no fibrocystic disease of the breast. The very term, anti thyroid, gives one pause?? Why would we want to be “anti” any gland in our body??? Most importantly – when will this drug industry driven endocrinological carnage stop? When will the public wake up and begin to bring the government sponsored medical quacks to justice to make amends for the terrible damage they have wrought – especially to our women and children particularly? If the tobacco industry and the corporate criminals cooking the books of large companies such as ENRON can be brought to justice, why not the medical goons and their drug company co-conspirators that are busily crippling and killing our loved ones?? A hint of the widespread, mind boggling damage being done daily by drug industry driven medical quacks is given by a very talented medical researcher in the June 2004 issue of THE ORIGINAL INTERNIST. In his article entitled “The Concept of Orthoiodosupplementation and Its Clinical Implications” Guy Abraham MD, wrote, "...medical textbooks contain several vital pieces of MISinformation [emphasis added] about the essential element Iodine, which may have caused more human misery and death than both world wars combined." [8,9] In other words, the medical scandal concerning the simple and recommended use of iodine in the form of Lugol's solution vs radioactive iodine and harmful goitrogens has resulted in more misery and death in the last 50 years than that attributed to the two big wars. 8. Abraham, GE. "The Wolf-Chaikoff effect of increasing Iodide intake on the thyroid." Townsend Letter, 2003; 245:100-101.9. Abraham, GE. "The safe and effective implementation of orthoiodosupplementation in medical practice." The Original Internist, 2004; 11(1):17-36. In the brilliant series of articles by Dr. Abraham and his fellow researchers I have deduced the following:1. The recommended daily requirement [150 micrograms] of iodine has never been properly established.2. The minimum daily requirement is actually about one hundred times the 150 micrograms recommended by medical authorities. Japanese consume 13.8 milligrams and more a day and suffer low breast cancer, fibrocystic breast disease etc. [u of Pa is now conducting studies on the effectiveness of iodine in breast cancer].2. About a third of the world's population is iodine deficient.3. Establishment medical quacks substituted dangerous and destructive quack remedies in the form of goitrogens and radioactive iodine to "burn out" or "shut off" thyroid gland function. 4. These same quacks blamed symptoms described as “iodism” [too much iodine] on levels of elemental iodine when in fact that they were caused by the MOLECULAR iodine in their biologically poisonous, goitrogenic, compounds.5. That there was clear evidence of chicanery on the part of the researchers in the development of prescription drugs to replace simple, effective therapy.6. The substitution of Bromine for Iodine in bread dough in the 1960s was probably the final stroke of bad luck for consumers in regards getting enough iodine in the diet to maintain proper thyroid function. [along with the addition of iodized salt]. We have medical authorities, members of the junk food industry and criminally negligent legislators to blame for this.7. In spite of the big clue published in JAMA, 238:1124, 1976 by Ghandrakant et al, Breast Cancer. Relationship to Thyroid Supplements for Hypothyroidism. Medical quacks insisted upon prescribing thyroid hormone to drive iodine deficient thyroid glands to function at higher levels – they even went so far as to prescribe synthetic hormone, SYNTHROID while disregarding the natural, more efficient, Armour brand already available and productive of far less destructive results.8. It doesn’t take a rocket scientist to figure out why we had such a sudden increase in breast cancer in this country. The increases in all the degenerative diseases can be laid right at the doorstep of modern medicine, especially when you factor in the disastrous effects of the use of hormone replacement therapy [hrT] and the use of Estrogen [the only known cause of breast cancer] and the distortion of natural Progesterone in favor of the patent medicine Progestin marketed as Progesterone that killed so many of our young women [strokes] back in the sixties. Any high school student wishing to take the time to do the research can come up with all the evidence necessary to prove this point. Indeed, I would recommend any high school student who happens upon this article to make the attempt. Who knows? You might become the hero of the 21st century!!! With such obvious and blatant quackery being indulged in our country with its mind boggling and tremendously underrated effects, one can only wonder about the activities of men such as Stephen Barrett MD and his MD friend Baratz who expend a lot of their time and energy attacking my profession and my discipline [Applied Kinesiology] while ignoring the deadly effects of what is being wrought in their own house. The world would be a better place if they would tend to their own “dirty linen.” They can be assured that I will continue to publicize the misdeeds of their profession at every opportunity. The time for justice is long overdue in the case of organized medicine, their drug cartel financiers with their lobbyists and the legislative stooges who live off the drug money that provides political campaign donations. I hope that this article will supply a little more ammunition for the gun that will eventually blow them all out of the water. In reading the below facts keep in mind the effects of all the halogens in our environment that interfere with Iodine – 1. fluorine in drinking water, 2. chlorine in drinking water, 3. chlorine in swimming pools, 4. Bromine in dough conditioners [iodine in flour dough was replaced by Bromine in the 1960s], 5. manmade sources of goitrogens in pesticides and medicines. When we add to the above list the hidden protein loss caused by the displacement of proteins forced to give up their sulfur to detoxification processes, we see possibly the greatest and most overlooked effects of such chemicals, the protein deficiency. In my experience , it is the rare degenerative or infectious disease that occurs in the presence of adequate dietary protein, indeed, many of the so called infectious diseases such as Tuberculosis have been known for decades to be protein deficiency diseases, a fact that is kept from the public in order to facilitate the sale of vaccines, antibiotics and other life and health threatening products. To give an example of the horrendous undercover effects of the great medical quackery, who could measure the disastrous effect on the public health by a simple thing such as convincing people that eggs are bad for them? With one foul swoop a large percentage of the population decides to eliminate eggs from their diet, denying themselves the very protein and sulfur needed to protect themselves against the hidden dangers lurking in their environment, not the least of which is the practice of orthodox medicine. A recent series of brilliant articles by Guy Abraham in the pages of THE ORIGINAL INTERNIST reminded me of one of the first lessons I learned from a fellow chiropractor, Vince Kulka, after opening my clinic doors in 1972 – the use of Iodine at hundreds of times the RDA and the use of the Iodine patch test [rubbing iodine on the skin to observe absorption time]. I was immediately successful back then in “melting” several goiters which seemed to be prevalent in this [heavy cow’s milk consuming] dairy community of Ashtabula county. [most of the family dairies have since closed down]. The purpose of this paper is to present to busy readers, in briefest form possible, a list of facts with references from my readings, pertinent to THYROID FUNCTION and IODINE metabolism - including the overlooked related diseases such as breast cancers, ovarian cysts and the lumpy breast syndrome [fibrocystic breast disease], a frequently found condition that continually pops up in the clinic these days which serves as a constant reminder of the need for IODEX topically and Iodine internally. I have been using IODEX, an iodine containing paste applied directly to the skin for the past thirty two years to help break up the intercostal pain and palpatory soreness at the sternum often suffered by a high percentage of Midwesterners, especially female hypothyroids. I was taught early on that Iodine loosens, Iron tightens, Bile dries and that the Ovary is uniquely involved with Iodine metabolism and that a balance must be maintained between thyroid hormone and estrogen. I was also taught early on that it was common practice for veterinarians to rub IODEX on the fetlocks of horses to eliminate cystic formations. Women are instructed to rub IODEX into the sore spots at the intercostals at bedtime until the soreness disappears [wear old nightclothes to protect against the staining of bedsheets] or to use it similarly during the day if possible. Ohio seems to continue to be a low Iodine intake region. Early studies demonstrating the effects of large doses of Iodine were performed on school children in Akron, a few miles south of my office, during the 1920s. The need for high doses of Iodine was known then – it was only the abuses involving FDA, AMA and the alphabet soup medically driven bureaucracies that brought about the misinterpretations, bad judgement and reductionist thinking resulting in what Dr Abraham describes as “iodophobia”. Mainland Japanese consume a hundred times the amount of Iodine that North Americans do. The coastal Japanese consume even higher amounts. RDA in this country has never been established by a scientific study. Recommended RDA in America is 150μg – Japanese consume 13.8mg! [end of comments] The two short paragraphs below were received from a lady website visitor with a large lump in her breast. She is under the care of an alternative medicine doctor. [emphasis added] http://www.helpmythyroid.com/IOD1.htmGuy E. Abraham M.D., Jorge D. Flechas M.D., and John C. Hakala R. Ph. “In the 19th edition of Remington's Science and Practice of Pharmacy, published in 1995, (11) the recommended daily oral intake of Lugol 5% solution for I supplementation was 0.1-0.3 ml. This time-tested Lugol solution has been available since 1829, when it was introduced by French physician Jean Lugol. The 5% Lugol solution contains 50 mg iodine and 100 mg potassium iodide per ml, with a total of 125 mg I/ml. The suggested daily amount of 0.1 ml is equivalent to 12.5 mg of I, with 5 mg iodine and 7.5 mg of iodide as the potassium salt. This amount of I is very close to 13.8 mg, the estimated daily intake of I in Japanese subjects living in Japan, based on seaweed consumption.” From Dr. Derry: “Lugol's solution is an iodine-in-water solution used by the medical profession for 200 years. One drop (6.5 mg per drop) of Lugol's daily in water, orange juice or milk will gradually eliminate the first phase of the cancer development namely fibrocystic disease of the breast so no new cancers can start. It also will kill abnormal cells floating around in the body at remote sites from the original cancer. Of course this approach appears to work for prostate cancer as prostate cancer is similar to breast cancer in many respects. Indeed, it likely will help with most cancers. Also higher doses of iodine are required for inflammatory breast cancer. As well we know that large doses of intravenous iodine are harmless whichmakes one wonder what effect this would have on cancer growth.I hope this helps you understand breast cancer better.” Dr. David Derry http://thyroid.about.com/library/derry/bl1a.htm IODINE METABOLISM -THE FACTS 1. Iodine is the only trace mineral used to synthesize hormones. J Clin Endocr and Met 1998; 83:3398-34002. Iodine is the most deficient trace mineral in the world. 1/3 of all peoples are deficient. J Clin Endocr and Met 1998; 83:3398-34003. Iodine deficiency is the number one cause of underfunctioning intellect. J Clin Endocr and Met 1998; 83:3401-084. The normal daily requirement of Iodine has never been determined. The Original Internist Dec 2002. p305. Reports on Iodine poisoning are misinterpreted, misunderstood and misrepresented to doctors and the lay public. One medical authority of wide influence, R. Arem MD, incorrectly reported [The Thyroid Solution…” 1999]that high Iodine intake caused increases in thyroiditis and thyroid cancer in Argentina. Just the opposite was true, low Iodine contributes to thyroid cancer. One archived anecdotal case from Dr Arem reported that 2.3 grams of Kelp/day caused Grave’s disease necessitating thyroid gland destruction. Japanese consume 4.6 grams of seaweed per day and continue to be amongst the world’s healthiest peoples. Arem unfortunately advises Iodine consumption be restricted to only 500 to 600 μg/day micrograms/day. The Original Internist Dec 2002 p30, 31.6. 15% females are Iodine deficient with urine levels less than 50 μg/L exposing them to prescription thyroid hormones by doctors who never check urinary Iodine levels. J Clin Endocr and Met 1998; 83:3401-08.7. Iodine works better than the hormones and lasts twice as long when discontinued. Eur J Clin Inv 1989; 19:527-534.8. Iodine deficiency predisposes to breast cancer and high fat diet predisposes to Iodine deficiency. J Epid Comm Health 2000; 54:851-858.9. Japan and Iceland have high Iodine intake and low goiter and breast cancer, just the reverse occurs in Mexico and Thailand. Quart Rev Surg Obstet Gynec, 1960; 17:139-147.10. Iodine protects against estrogenic effects in breast cancer. JAMA 1967; 200:115-119, Adv Exp Med Biol,1977; 91:293-304.11. Thyroid hormone therapy contributes to breast cancer in Iodine deficient women. JAMA , 1976; 238-1124.12. In the usually misleading establishment organ Cancer, 1964, 17:1174-76 – effects of Iodine deficiency were incorrectly interpreted based upon goiter incidence in Michigan. Goiters decreased from 38.6%-1.4% between 1921 and 1954 with no change in breast cancer. Their mistake was that they presumed incorrectly that the amount of Iodine needed to prevent goiter would be equal to the amount to prevent breast cancer. However two studies show that in woman and female rats it takes 20 to 40 times the amount of Iodine needed to control breast cancer and fibrocystic disease than it does to prevent goiter. Can J Surg 1993; 36:453-460, Biological Trace Element Research, 1995; 49:9-19.13. Many drugs contain Iodine. Bad Side effects of Iodine containing drugs are usually blamed on the Iodine they contain without ever submitting the hypothesis to a study. Good effects are attributed to the drug. The Thyroid, Werner & Ingbar, Lippincott 2000 316-329.14. Amiodarone is an antiarrythmia drug that contains 75 mg Iodine per 200 mg tablet that releases 9mg/day Iodine/day. 20% of users of Amiodarone develop hypothyroidism. It also causes destructive thyroiditis for which large amounts of glucocorticoids are prescribed or occasionally, thyroidectomy. The authors Roti and Vagenatis [The Thyroid above] blame the Iodine for the side effects. Japanese actually consume 13.8 mg Iodine daily and enjoy one of the lowest incidences of hypothyroidism and Iodine deficiency goiter. Quart Rev Surg Obstet Gynec, 1960; 17:139-147.15. The widely read textbook on Thyroid Werner and Ingbar’s, The Thyroid, edited by Braveman and Utiger, Lippincott 2000 contains a subsection in which Iodine is identified as a pathogen. Title of the article is “Iodine As A Pathogen” and daily intake above 500 μg is considered excess, an amount equal to only 3% of the daily intake in Japan, a country with extremely low female reproductive organ cancers. Int J Cancer 1986, 38:325-329 Japanese mainlanders consume 100 times more Iodine than Americans and coastal Japanese consume higher amounts than the mainlanders.16. Thiocyanate is a goitrogen and caused hypothyroidism in rats on regular RDA amounts of Iodine. The effect of the goitrogen was eliminated by increasing the rat Iodine intake to 80 times the RDA. Hormone & Metabolic Res 1995 27:450-454.17. When Iodine was used in dough during the sixties one slice of bread a day contained the RDA of 150 μg and the breast cancer risk was 1:20. The use of Iodine in bread dough was replaced with the goitrogen Bromine based upon ill conceived, reductio absurdum results of lab driven reductionist medical methods. due to stupid medical reductionist thinkingmedical stupidity and the rate of breast cancer has soared to 1:8 and is increasing at 1% a year.18. Prescribing thyroid T4 to hypothyroids increases susceptibility to breast cancer. JAMA 1976; 238:1124.19. To overcome the effects of goitrogens in the food chain such as Bromine in dough, amounts of Iodine used in Japan would be necessary. Hormone & Metabolic Res 1995, 27:450-454. 20. The last common food source for Iodine in the USA is iodized salt and the stupidity of medicine surfaces again as the prestigious J of Clinical Endocrinology and Metabolism recommends cutting DOWN the amount of Iodine in salt to half the amount now present! The title of the article is “Guarding our Nation’s Thyroid health”.21. The percentage of thyroidal uptake of Radioactive isotopes of Iodine from nuclear catastrophe is increased in areas of severe endemic goiter reaching levels of 80%. Am J Clin Nutr 1974, 27:96-103.22. Iodine protects against uptake of the radioactive isotopes of iodides. The more Iodine consumed in the diet, the lower the percentage of uptake of radioactive isotopes by the thyroid gland. Werner and Ingbar’s, The Thyroid, edited by Braveman and Utiger, Lippincott 2000, 295-329.23. At Iodine RDA levels of 150 μg, uptake of radioactive Iodine is 20-30% of intake. When Iodine was introduced into bread dough in the sixties the Iodine intake increased 4 to 5 times the RDA and the Iodine uptake was decreased to below 20%. NEJM 1969; 280:1431-1434. SUMMARYOrthodox medicine, throughout recorded history has used a wide variety of substances and surgical techniques in an attempt to relieve pain and suffering, to fight disease and to improve health. As a result, the practice of crisis medicine, greatly facilitated by technological rather then medical progress, has rescued us from congenital problems, accidents and trauma, however, statistically, the practice of patent medicine more than cancels out all benefits gained by technological advances. The practice of orthodox medicine is a life threatening, health robbing enterprise of mind boggling proportions having absolutely unbelievable effects on life and health - exactly opposite that which is portrayed daily on television and in the popular news media. For every patient helped by crisis medicine some unknown but more than likely, mind boggling number, are worsened and even killed outright [E.g.: 11,000 victims of the SMON “epidemic” in Japan during the 50s and 60s; thousands of Swine flu vaccine victims during the 70s; thousands of US victims killed by AZT during a similar medical crime during the 80s and 90s AIDS fiasco; more recently 80 [known and publicly admitted] victims of Baycor, the Bayer Aspirin company’s cholesterol reducing drug; and most recently, thousands upon thousands of [mostly unreported] infants and schoolchildren victims of mercury poisoning from totally unnecessary and extremely destructive vaccines especially during the 90s.] I would estimate that for every patient helped by crisis medicine at least a hundred or more are killed, maimed, momentarily or irreversibly damaged by biological poisons. I just lost a long time patient who had moved to Florida after retiring. He started on LIPITOR after departing from our influence and died unexpectedly of a heart attack. A very vigorous, family oriented man who should have lived to be 90 or more. The painfully evident statistical fact is that humanity would be far better off without an organization of doctors and no free country can long survive the intrusion of government in medicine and especially, an organization of doctors wielding government power. We can learn from our mistakes and experience but not when governed by a group of self appointed protectors [AMA, FDA, CDC, NIH] who continually interfere with the propagation of knowledge useful to health and most importantly, PREVENT THE LEARNING FROM TAKING PLACE. Improvements in health attributed to medicine have been gained by improving the tools of production and improvement in other forms of technology such as 18 wheelers that deliver fresh foods during all seasons regardless of weather [the direct result of which is a continual decrease in the number of diseases [incorrectly] labeled as “infectious” by “bug happy” doctors]. Other small improvements in health and longevity can be attributed to what medicine has STOPPED doing rather than BEGUN. Bloodletting is one example, another, the elimination of the especially poisonous old remedies such as CALOMEL the escape from which unfortunately only lasted until mercury was again used in vaccines under the label THIMEROSAL which faked out even the pediatricians using it on newborn infants, bringing about the most horrendously sudden increase in iatrogenic disease in all recorded history. Government statistics show that Cases of Autism have increased several thousandfold in some areas of the country. Indeed, careful investigation, reevaluation and reinterpretation of historical evidence demonstrates that the poor health of the nation and for that matter, the entire world can be laid directly on medicine’s doorstep. The evidence does demonstrate that doctors do, in fact, kill more people than generals and wars. Only a small percentage of the population is aware of this at any given time in history which explains why doctors continue to enjoy their self appointed position as the guardians of health. Dr Daniel H Duffy SrMay 27, 2004Rewritten August 12, 2004 LUGOL’S SOLUTION IS AVAILABLE IN TABLET FORM in Lugol’s original ratio of iodine to iodide. Call 1-800-223-1601 – ASK FOR IODORAL…professional discounts for quantity orders are available. WANT TO KNOW IF YOU’RE IODINE DEFICIENT?? SEND FOR DR FLECHAS’S 24 HOUR URINE TEST FOR $75. A test dose of iodine is taken followed by a 24 hour collection of urine – normal excretion is 90% of test dose. Jorge D. Flechas, M.D.#80 Doctors Drive Suite 3Hendersonville, NC 28792Office: (828) 684-3233Fax: (828) 684-3253Email: drflechas Effect of daily ingestion of a tablet containing 5mg Iodine and 7.5mg Iodide as the potassium salt, for a period of 3 months, on the results of thyroid function tests and thyroid volume by ultrasonometry in ten euthyroid Caucasian Women.Guy. E. Abraham M.D., Jorge D. Flechas M.D., and John C. Hakala R.Ph., The Original Internist 9: 6-20, 2002 Iodine sufficiency of the whole human bodyGuy. E. Abraham M.D., Jorge D. Flechas M.D. and John C. Hakala R.Ph., The Original Internist 9: 30-41, 2002. Effect of daily ingestion of IodoralGuy. E. Abraham M.D., Jorge D. Flechas M.D. and John C. Hakala R.Ph. The Wolff-Chaikoff Effect: Crying Wolf? Guy E. Abraham, M.D. More to come later A MORE TECHNICAL ARTICLE Measurement of urinary iodide levels by ion-selective electrode: Improved sensitivity and specificity by chromatography onanion-exchange resin. Guy. E. Abraham M.D.1, Jorge D. Flechas M.D.2 and John C. Hakala R.Ph.3 I. Introduction The last national nutritional survey (NHANES III 1988-1994) revealed that 15% of the U.S. adult female population are iodine-deficient, as defined by the World Health Organization: levels of iodine/iodide (I) below 50 ug/L (1). That is one out of every 7 female patients walking in a physician’s office. Yet, rarely do physicians order urine I levels, even in patients with simple goiter and hypothyroidism. Such patients are usually prescribed thyroid hormones. There is convincing evidence that I deficiency predisposed to fibrocystic disease of the breast (FDB) and breast cancer (2-8). Administration of thyroid hormones to I-deficient women increased further their risk of breast cancer (9). Forty years ago, the risk ratio for breast cancer in our population was one in twenty and now it is one in eight (10), coincident with an increased prevalence of I deficiency in our population (1). To encourage physicians to perform routine urine I determination in their practice, a simple method will be described to accurately measure urine I levels. This technique uses quantification of iodide by a potentiometric method, using an ion-selective electrode (ISE). Urinary iodide is measured by the electromotive force (EMF) generated on the iodide-selective electrode due to the presence of iodide in the urine sample. Within a certain range of iodide concentrations, there is a linear relationship between the logarithm of iodide concentration and the EMF generated. The concentration of chloride in urine is usually one millionfold higher than iodide and there is a significant interference by chloride in the analysis of urinary iodide by the ISE method. To prevent this interference, purification of the urine sample by anion exchange chromatography is performed prior to ISE measurement. This assay is simple, rapid, with results within one hour, if the ISE measurement is performed in the physician’s office. We also present preliminary data on an I-loading test to assess I sufficiency of the whole human body. II. Motivating factor in the development of the assay Mainland Japanese women have a very low incidence and prevalence of FDB and breast cancer (11). Several investigators have proposed that the essential element I was the protective factor in mainland Japanese (2-8). If indeed, the essential element I is the postulated protective factor, the administration of I to American women in amounts equivalent to that consumed by mainland Japanese women would be expected to protect them from breast cancer and improve FDB, as previously proposed by Stadel for breast cancer (12) and confirmed for FDB by Ghent et al (5). Based on data supplied by the Japanese Ministry of Health, the average daily I intake in mainland Japanese is 13.8 mg (13). We evaluated the effect of 2 drops of Lugol solution in tablet form containing 5 mg of iodine and 7.5 mg iodide as the potassium salt, (Iodoral®, Optimox Corporation, Torrance, CA), administered daily for 3 months to 10 normal women. Informed consent was obtained from all subjects participating in the studies described in this manuscript. This supplement had no adverse effect on ultrasonometry of the thyroid gland, the serum levels of thyroid hormones, blood chemistry, hematology, and urine analysis (13). This form and amount of I was chosen because it was widely prescribed during the early and mid 1900’s for I replacement therapy (13-16). The amount of 12.5 mg of I present in 2 drops of Lugol is very close to the estimated mean daily intake of 13.8 mg I by mainland Japanese (13). <!--[if !vml]--><!--[endif]--> According to the medical literature, urinary I level is the most valid index of I intake (17, 18). Using a commercial laboratory (Doctor’s Data Inc., Chicago, Ill.), we followed the pattern of 24 hour urinary I excretion before and after ingestion of one tablet of Iodoral® in 2 male and 3 female subjects. To our surprise, both male and female subjects who ingested one tablet of Iodoral® containing 12.5 mg I, excreted in their 24 hr. urine samples only 10 to 30% of the I ingested, with a mean of 20% (Table I). There are two possible explanations for this finding: Low bioavailability of the solid dosage form of the I tablet; or high retention by the body. If this was due to low bioavailability, prolonged administration of this I supplement should not result in an increased urinary excretion; otherwise, as the body becomes more I-sufficient, a greater percentage of the ingested I would be excreted. In order to elucidate the cause of this low I excretion, we continued the administration of I in those subjects for one month. Then, we repeated the 24 hr. urine collection and I was measured again in the collected urine samples. <!--[if !vml]--><!--[endif]--> Following one month of daily ingestion of one tablet of Iodoral®, the excretion of I increased to 36-96% of the oral amount in 4 of the subjects with a mean of 50% in the 5 subjects (Table I). Female Subject #2 excreted only 10% of the oral dose after one month of supplementation. She had the lowest baseline I level (0.022 mg/24 hr) and the greatest I retention after one and 30 days. The only distinctive feature of this subject was mammomegaly (size 40D). This would suggest a very important role of the mammary glands in the requirement for I by the whole human body. To our knowledge, the above findings have not been previously reported. The implication of such observation is that an I-loading test could be developed to assess not just thyroid sufficiency but I requirement of the whole human body. However, for such a test to be practical, one month duration is too long. So, the next alternative was to progressively increase the amount of I in a single dose and to measure urinary I excretion in order to find the amount of ingested I that would result in the greatest between individual differences of urine I levels, as an index of degree of whole body I sufficiency. The standard deviation from the mean value could be used as an index of the between-individual variations. Another group of 6 subjects, 3 males and 3 females were evaluated with 24 hour urinary I levels before and after ingesting one, two and three tablets of the same preparation. The subjects retained approximately 80% of the I content of one and two tablets (Table II). But with three tablets containing 37.5 mg of I, there was a twofold difference in I excretion, with a range of 6.8 to 14 mg I (18%-37%) (Table II). The means ± SD of urinary I levels (mg/24 hr.) for the 3 doses of I were: 2.8 ± 0.14 (C.V. = 5%) for one tablet of Iodoralâ; 5.4 ± 0.35 (C.V. = 6.5%) for 2 tablets; and 9.48 ± 4.6 (C.V. = 48.5%) for 3 tablets. There was a 10 fold increase in the coefficient of variation around the mean value at 3 tablets of the I supplement, compared to one and two tablets. Subject #3 who retained the most I, with only 6.8 mg (18%) in the 24 hour urine collection, suffered from severe FDB, again pointing at the mammary glands as an important organ of I utilization. These results suggest that the measurement of urinary I levels before and after administration of three tablets of Iodoralâ, could be used as an I loading test to assessI sufficiency of the whole human body. <!--[if !vml]--><!--[endif]--> For the I-loading test to be widely used in the physician’s office, the measurement of urine I levels would be best performed in situ, using a simple method with non-hazardous reagents. The values for I presented in Tables I and II were obtained by a procedure called Induction Coupled Plasma-Mass Spectrometry (ICP-M.S.). The equipment required for this procedure is extremely expensive and very complex in their utilization. The ISE method is very simple, requiring only the following two reagents: water and sodium nitrate. Sodium nitrate is used in the ISE method as an Isotonic Strength Adjuster (ISA) at an initial concentration of 5 Moles/L to improve performance of the ISE electrode. The ISA is diluted 1 part ISA to 2 parts of iodide standards and urine samples. The final concentration of NaNO3 in the assay is 1.66 Molar. The ISE procedure does not require any special precaution, beside the usual good laboratory practice. Water and NaNO3 are used in the ISE measurement and in the chromatographic purification of urine samples on anion-exchange resin, simplifying the procedure. III. Measurement of iodide in biological fluids by ion-selective electrode: A review of pertinent publications. A) Urinary iodide In 1983, Cooper and Croxson (19) wrote a “Letter to the Editor”, published in the Journal of Clinical Chemistry, describing their unsuccessful attempt to measure urine iodide levels in New Zealanders by the direct ISE method, using equipment from Thermo Orion, Beverly, Mass., USA. The high concentration of chloride present in urine samples interfered in the assay. They were unable to achieve reliable and reproducible results. They postulated that chloride was the interfering substance due to the persistence of this interference following deiodization of urine by chromatography on anion-exchange resin. This procedure retained iodide on the column, but chloride was eluted in the chromatographed urine. Not only the presence of chloride rendered the assay non-specific for iodide, but caused also a decrease in sensitivity by one order of magnitude. With standards of iodide in water, the sensitivity was 10–6 M (0.127 mg/L), but with standards in deiodized urine, the sensitivity was 10–5 M (1.27 mg/L). It is surprising that these authors did not carry their experiments to the next logical step: Use the same anion-exchange resin to purify iodide from chloride. Since chloride was eluted with the chromatographed urine but iodide was retained on the column, they could have used a high ionic strength buffer to elute the iodide fraction afterward. The urinary I levels of New Zealanders are 10 to 20 times less than the sensitivity of 1.27 mg/L. These authors concluded: “We conclude that, on the basis of chloride error, the iodide-selective electrode is unsuited for the accurate experimental determination of iodide in urine.” In 1986, Yabu et al (20) came to the realization that the New Zealander’s problem was not a problem at all for mainland Japanese. Although they confirmed Cooper and Croxson’s findings that the assay was not specific below 1.27 mg/L, mainland Japanese excreted higher levels of urinary iodide than 1.27 mg/L. In 163 urine specimens analyzed, only one specimen had a concentration below 1.27 mg/L. They observed I levels in these urine samples ranging from 0.6 mg/L to 17.4 mg/L. If those I levels are expressed as mg/24 hr. and assuming an average 24hr. urine volume of 1.5 liter, the range of I excretion per 24 hr. would be from 1 to 25 mg in these 163 Japanese subjects. This range is in agreement with the estimated average daily I intake of 13.8 mg I in mainland Japanese (13). The iodide levels observed in the mainland Japanese were two orders of magnitude higher than urinary iodide concentrations in New Zealanders, for that matter, in citizens of the Western World (13). In 1993, Kono et al (21) using direct measurement of urine iodide in 2956 men and 1182 women confirmed the reliability of the direct ion-selective electrode assay in urine samples from mainland Japanese subjects. However, Yabu and Kono were not able to measure accurately iodide levels below 1.27 mg/L, due to chloride interference. Above that level, they achieve excellent correlation with an established assay for urinary iodide, the ceric ion-arsenious acid method (22). It is of interest to note that the electrode and meter used in the 2 publications from Japan were obtained from Radiometer, Copenhagen, Denmark. This company supplies a procedure to perform direct measurement of urinary iodide with their equipment. B) Milk iodide In 1980, Lacroix and Wong measured iodide directly in cow milk by ion selective electrode (23). They reported a value ranging from 0.14 to 0.35 mg/L, when the milk analyzed was taken raw from individual cows. Market milk contained mean levels ranging from 0.52 to 0.70 mg/L. These authors did not perform experiments to prove the specificity of their procedure. In 1984, Gushurst el al (24) measured iodide in human milk by ion-selective electrode. They observed values ranging from 0.029 to 0.45 mg/L. Since the concentration of chloride in milk is 10 times less than in urine (25), they were able to measure iodide levels down to 0.029 mg/L. The studies performed with milk samples used iodide-selective electrode and meter from Thermo Orion, Beverly, Mass., USA. The authors of these studies did not confirm specificity of their assay by comparison with an accepted method. IV. Purification of urine samples by anion-exchange chromatography prior to assay of iodide For the ISE method to become widely used in the clinical setting, it must be reliable at all levels of urinary iodide, down to levels observed in severe I deficiency (<0.025 mg/L). To our knowledge, a procedure combining prior chromatographic purification to improve specificity and sensitivity of the ISE assay of iodide in biological fluids has not been published. In our opinion, purification prior to ISE measurement is a sine qua non requirement for specificity and sensitivity of the ISE assay under all physiological and pathological conditions, including severe I deficiency (urine I <0.025 mg/L). Chromatographic purification of urine samples on columns of anion-exchange resin was selected for the reasons described below. In 1962, Murthy et al (25) reported a procedure for removing radioactive iodide from milk. A strong anion exchange resin was used (Dowex 2 X 8) to retain the radioactive iodide and large volume of milk could be processed through these columns. A mean ± SD of 98 ± 2% of the iodide could be retained on the columns when 120 bed volumes were chromatographed. The bed volume is approximately 1 ml per gm of resin. They were able to elute approximately 98% of the radioactive iodide from the column with 30 bed volumes of 2N sodium nitrate (NaNO3) in 0.16N HNO3. This publication was of great interest to us since the ISE assay of urinary iodide published by the Japanese scientists (20, 21) used 5 ml of 5N NaNO3 as ISA, added to 10 ml of urine. We postulated that by prior chromatographic purification of urine samples on anion exchange resin and using 5N NaNO3 as the elution solvent to elute iodide, measurement of iodide could be made directly after adding 2 volumes of water to the eluant. Materials used in anion exchange chromatography are composed of 3 components attached together and placed in a column: the base or backbone support; the functional group or ion exchanger, and the counter ion available for exchange. For backbone, styrene divinyl benzene (SDB) was preferred over silica gel because it is more rugged, less sensitive to pH changes and possesses a higher capacity (26). For example, SAX columns with silica backbone are available from Varian and Associates (Harbor City, CA) with a capacity of 0.85 m Eq/gm of resin. However, with SDB backbone, Alltech (Deerfield, Ill) quotes a figure of 1.5 m Eq/gm, a 75% greater capacity to exchange anions. This translates into the ability to process a 75% greater volume of urine for the same amount of resin. Strong anion exchangers are quaternary amines versus weak anion exchangers, which are primary, secondary and tertiary amines. Strong anion exchangers are always charged at any pH; therefore elution of the analate of interest could be achieved by increasing the ionic strength of the elution solvent without any acid added. Data are available for strong anion exchangers regarding the relative selectivity of halides (26): With fluoride as unity; chloride has a relative selectivity of 10; bromide 28; and iodide 87. The higher the number, the stronger the binding of the halide to the anion exchanger. The stronger the binding of the halide to the ion exchanger, the higher the ionic strength required for elution. Therefore, by choosing a wash solvent with ionic strength high enough to elute fluoride, chloride and bromine, but not high enough to elute iodide, a high degree of purity of the iodide fraction could be achieved.For counterions, the choice from products available commercially, was between chloride and acetate. Since chloride interferes in the assay, we chose the acetate form (Fig. 1). Although a wide range of counterions could be prepared by preconditioning the anion exchange columns, this would not be practical in a clinical setting. The ideal counterion on the SAX columns used for the purification of iodide from the other halides would be nitrate. Based on information supplied by Alltech with the SAX columns, iodide is the only halide capable of displacing nitrate from the tetramethylamnonium group. The smaller pore size of 60Å was preferable because it excluded molecules with molecular weight above 1000 and it prevented overloading the resin with high molecular weight anions present in urine samples. Finally, the larger particle size was chosen because it allowed elution at the proper flow rate with lower pressure and vacuum. In Table III are displayed the various options commercially available for anion exchange chromatography. The characteristics chosen are in the right column. <!--[if !vml]--><!--[endif]--> <!--[if !vml]--><!--[endif]--> The strong anion exchanger SAX was obtained from Alltech (Deerfield, Ill) and tested with bed weights of 100, 200, 500 and 600 mg of SAX. The bed weights of 300 and 400 mg were not available commercially. This resin has a SDB base with a functional group of tetramethyl ammonium and with acetate as counterion (Fig. 1). We were interested in a column of SAX that had the capacity to handle up to 30 ml of urine without overload and breakthrough of iodide. The reason for this will be explained later. Preliminary tests revealed that 500 mg of SAX was the minimum bed weight required to process 10 to 30 ml of urine without overload (breakthrough) of the column. Overloading the column resulted in the presence of iodide in the urine eluate after the first pass, causing low recovery of iodide in the purified fraction eluted with the high ionic strength solvent. The 500 mg column with a 10 ml reservoir was chosen (Alltech part #309750). Ten ml of urine was applied to the SAX column, which was fixed on top of a vacuum manifold (Applied Separation Inc., Allentown, PA), connected to a vacuum pump (Alltech, Deerfield, Ill). We used the model # Bench Top Vacuum Station which was capable of maintaining a preset vacuum. A vacuum of only 2 inches (50 mm) of mercury was sufficient for an elution flow rate of 4-5 ml/min. Due to variation in airflow through the different openings of the vacuum manifold and variation of elution flow rates between the columns, there was a twofold difference between columns with the fastest and slowest flow rate. The elution of 10 ml of urine required 2 to 4 minutes at the vacuum setting of 50 mm Hg. The 4 halides, fluoride, chloride, bromide and iodide were added individually in known amounts from stock standard solutions to pooled urine samples collected from a fasting subject. Using Thermo-Orion ISE electrodes and special reagents, the halides were measured following chromatography in the eluted urine, in the wash solvent (10 ml of 0.5N NaNO3) and in the elution solvent (5 ml of 5N NaNO3). The standard curves for the 4 halides are displayed in Fig. 2. <!--[if !vml]--><!--[endif]-->The eluted urine contained fluoride and 75-80% of the chloride. Some 20-25% of the chloride was retained on the column, together with bromide and iodide. A wash of the column with 10 ml of 0.5N NaNO3 eluted the retained chloride and the bromide. Quantitative recovery of iodide (>95%) was achieved with 5 ml 5N NaNO3. The eluant containing the iodide in 5 ml of 5N NaNO3 was mixed with 10 ml of water and measured directly by immersion of the iodide selective electrode (Orion Electrode #9653 BN) connected to the Orion Meter 720-A Plus. Standards of potassium iodide (Spectrum Chemical, Gardena, CA #P0185) were prepared in water at concentrations ranging from 10–3 M to 10–8 M. A volume of 10 ml of iodide standard was mixed with 5 ml of 5N NaNO3 prior to measurement by the iodide selective electrode. The stored standard curve in the 720-A Plus meter was programmed to display the urinary I levels in mg/L. V. Methodology Urine samples collected over a period of 24 hr were stored by the subject during collection in a 3 liter plastic bottle, supplied by Doctor’s Data Inc. After measurement of the total volume at the clinic, sodium azide was added at a final concentration of 0.05% for bacteriostatic purpose (10ml of a 5% solution per liter of urine). Sodium azide is the commonly used bacteriostatic agent in such cases (20). Prior to addition of the sodium azide, a sample was obtained and mailed to Doctor’s Data for analysis by ICP-M.S. Samples of the collected urine were then stored at -20º C in plastic containers until assayed by the ISE method. Repeated freezing and thawing the urine samples had no significant effect on the measured I levels. However, without a bacteriostatic agent, such manipulation of the samples resulted in decreasing I levels and evidence of bacterial growth. Aqueous solutions of 0.5N and 5N NaNO3 (Spectrum Chemical #SO183) were prepared and stored at room temperature. A stock solution of potassium iodide 1.66 gm in 1 liter of purified water (10-2 Molar) was stored in a dark glass bottle. From this stock solution, iodide standards were prepared by dilution to contain a range from 10-3 M(127 mg/L) to 10-8 M (0.00127 mg/L). Under a vacuum of 40 to 50 mm Hg, 10 ml of urine was applied to a SAX column 500 mg, with a 10 ml reservoir (Alltech #309750) and the elution flow rate adjusted so not to exceed 4-5 ml/min. This is the most critical step in the assay. A slower flow rate did not have an adverse effect on the performance of the anion-exchange columns. Exceeding this flow rate however, caused breakthrough of iodide in the urine eluate, with low recovery of iodide in the assay. At the same vacuum setting, the elution flow rate decreased with the wash and elution solvents. Therefore, it was very important to set the flow rate during the elution of the urine sample. Since there was variation in flow rate between the columns, the SAX column with the highest flow rate was used to monitor visually the urine level in the reservoir. To facilitate this process of observing urine levels through the opalescent wall of the reservoir, a food coloring was added to the urine samples prior to chromatography. FD & C Green No. 3 (Warner Jenkinson Company, St. Louis, Missouri) was selected for its useful attributes. Having 2 benzene rings in its molecule (Fig. 3), resulted in a very strong hydrophobic interaction with the benzene rings in the SDB backbone of the SAX (Fig. 1). FD & C Green No. 3 was retained on the column, resulting in a clear eluate. Although FD & C Green No. 3 contains a quaternary amine (Fig. 3) capable of binding iodide, its concentration was so low that no significant interference was observed in the performance of the columns. We added 1 ml of a 1% solution per liter of urine. The amount of that dye in 10 ml of urine was 0.2 µMole, compared to a concentration of 750 µMoles of quaternary amines on the SAX column. FD & C Green No. 3 has antiseptic, therefore bacteriostatic properties, since it is used topically and orally in veterinary medicine as an antiseptic (27). We are currently testing FD & C Green No. 3 as a bacteriostatic agent to replace sodium azide. So far, the results look very promising. <!--[if !vml]--><!--[endif]-->We have tested several SAX columns with both silica and SDB backbones obtained from Alltech and Varian. The vacuum setting required for the proper elution flow rate varied widely between SAX columns with as much as 15 inches (375 mm) Hg for some SAX columns with silica backbone and small particle sizes. With the Alltech 500 mg SAX columns, however, a vacuum setting of50 mm Hg resulted consistently in the proper flow rate. The Alltech vacuum pump displayed the ambient atmospheric pressure in mm Hg. The desired vacuum was achieved by setting the vacuum pump at 50 mm below ambient. Chromatography of the urine sample on the SAX column yielded 3 fractions, which were used to measure fluoride, bromide and iodide. The flow chart in Fig. 4 summarized this procedure. The eluted urine contains >95% of the fluoride and 75-80% of chloride. Ten ml of the special ISA TISAB II (Thermo Orion #940909) was added to the 10 ml of eluted urine and fluoride level was measured with electrode #9609BN. The wash solvent consisted of 10 ml of 0.5N NaNO3 and following chromatography on the SAX column contained 20-25% chloride and >95% bromide. Using the electrode #9635BN, bromide levels were measured following addition of 5 ml of 5N NaNO3 to the eluted wash solvent. The bromide standards used to compute the standard curve were prepared in0.5N NaNO3. Validation of the bromide assay will be the subject of another report. The last step was the addition of 5 ml of 5N NaNO3 to the column and elution of iodide at the same vacuum setting, although the flow rate was less, between 2 to 4 ml/min. Ten ml of water was mixed with the eluted 5 ml 5N NaNO3. Iodide concentration was measured directly by immersion of the electrode (Orion #9653 BN). <!--[if !vml]--><!--[endif]--> VI. Acceptability of the ISE method for urinary iodide measurement We followed the same procedure we previously described for the validation of radioimmunoassay of steroid hormones in biological fluids (28, 29). The criteria for acceptability of an assay includes reliability and practicability. The reliability of an assay depends on its sensitivity, specificity, accuracy and precision. The practicability of an assay is judged by the skill required to perform it, the time involved in its performance and the cost of the assay. A) Reliability experiments 1) Sensitivity The theoretical limit of sensitivity achievable with ISE assay of urinary iodide is set by the sensitivity of the iodide selective electrode itself. From data supplied by Thermo Orion, the sensitivities of the ISE electrodes for halides are: For iodide, 5 x 10-8 M; for fluoride, 10-6 M; for bromide, 5 x 10-6 M; and for chloride, 5 x 10-5 M. The iodide selective electrode is by far the most sensitive being 20 times more sensitive than the ISE electrode for fluoride, 100 time more sensitive than for bromide and 1000 times more sensitive than for chloride. Expressed as mg/L, the iodide selective electrode is sensitive down to 0.006 mg/L, compared to a sensitivity of 0.003 mg/L, for ICP-M.S. used by Doctor’s Data Laboratories. (Information on sensitivity of ICP-M.S. supplied by Dean Bass). In achieving this theoretical sensitivity, other conditions are important. First, the sensitivity of the standard curve is a limiting factor. The sensitivity of the standard curve is defined as the smallest amount of iodide that is significantly different from zero at the 95% confidence limit. In order to compute the standard curve, (the dose response curve) the EMF expressed in millivolts (mV) was plotted on the Y-axis against the logarithm of increasing amount of iodide, from 10-3 M to 10-8 M on the X-axis. The iodide selective electrode was extremely sensitive (Fig. 5), with a linear response from 10-3 M to 10-7 M. A mean D EMF of 61 mV per decade was observed from 10-3 M to 10-7 M, but from 10-7 M to 10-8 M, the standard curve became non-linear with only 36.2 mV per decade. <!--[if !vml]--><!--[endif]--> To calculate the mean blank value, samples containing zero iodide are run in the assay using several replicates, ideally 6 replicates. The sensitivity would then be equal to 2 standard deviations from the mean blank value, after subtracting the mean blank value. We tested water blanks and deiodized urine blanks. When 6 samples of water of 10 ml each were chromatographed on the SAX column as described under methodology, we obtained a mean ± SD of 0.0024 ± 0.0006 mg/L. Deiodized urine was prepared as described by Cooper and Croxson (19). The 95% confidence limits of the mean blank were: 0.003 - 0.005 mg/L. Based on this information, a sensitivity of 0.005 mg/L could be achieved, a value very close to the 0.006 mg/L suggested by Thermo Orion. This sensitivity however could be improved by threefold, using 30 ml of urine for chromatography, but keeping the wash solvent volume at 10 ml and elution solvent volume at 5 ml. Using 30 ml of urine, the sensitivity in measuring I in urine samples by the ISE method was 0.0017 mg/L, comparable to the sensitivity of ICP-M.S. 2) Specificity There are various ways of validating an assay in terms of its specificity, one of which is by comparison with an accepted method. Yabu et al (19) and Kono et al (20) validated the specificity of the ISE method for direct measurement of urinary iodide levels by comparison with the ceric ion-arsenious acidmethod (21). However, their direct assay without prior purification proved unreliable with urinary I levels below 1.27 mg/L. In our U.S. population, based on the latest nutritional survey, only 5% of urine samples evaluated, had I levels above 0.5 mg/L (1). Therefore, the direct ISE method for urinary I levels, although acceptable for mainland Japanese, would be worthless in our population. By prior purification of the urine samples using anion-exchange chromatography, we were able to achieve a sensitivity 250 times better than that reported by the Japanese authors, and 750 times better if 30 ml of urine were chromatographed on the SAX column. <!--[if !vml]--><!--[endif]-->To validate the specificity of our procedure, we chose the ICP-M.S. as the valid, accepted method. From the data presented in Tables I and II, urine samples were available for comparison from 10 subjects (one sample per subject) for baseline I levels; and urine samples from the 6 subjects in Table II were used for the post-I supplementation comparison of the ISE method with ICP-M.S. Out of 18 samples analyzed by ICP-M.S. in those 6 subjects following I-supplementation; 15 samples were available for comparison with the ICP-M.S. method. With baseline urinary I levels between 0.022 mg/24 hr. to 0.25 mg/24 hr. in the 10 samples used for comparison (Fig. 6), a correlation coefficient of 0.996 (p<0.001) was obtained. For urinary I levels expected in the U.S. population, the ISE method described in this manuscript is therefore a reliable assay and the cost of setting up the ISE procedure is within the reach of the average clinician. We have not achieved as good a correlation with ICP-M.S., using urine samples with I levels in the range observed in mainland Japanese, that is 100 fold higher values. Urinary I levels following 3 tablets of IodoralÒ were consistently higher by the ISE method, being as much as 65% higher than reported by ICP-M.S. For example, in sample #13 (Table IV), a value of 11 mg I/24 hr. was reported by ICP-M.S. following 3 tablets of IodoralÒ. We measured 18.2 mg I/24 hr. in the same sample. Another sample from the same urine collection was sent to Doctor’s Data, but labeled as a new sample. The repeat value was 16 mg I/24 hr. One of us (GEA) talked to Dean Bass who was very helpful. He explained that his equipment is calibrated to measure I levels within the range expected in the U.S. population, that is from 0.012 to 0.5 mg/24 hr. The accuracy of their assay, however, will not be as good with I values 100 fold higher, unless the urine samples were diluted 100 fold. He exhorted us to share this information with other physicians who plan to use Doctor’s Data for I analysis and who are using our program: Clearly mark on urine samples “High iodide levels!! Dilute 100 fold prior to measurement.” We have not observed this carry-over effect even with a difference of 1000 fold between urine I levels of consecutive samples, using the ISE method and carefully washing the electrode between measurements. <!--[if !vml]--><!--[endif]--><!--[if !vml]--><!--[endif]--><!--[if !vml]--><!--[endif]-->3) Accuracy The accuracy of the ISE method was tested by recovery experiments. To deiodized urine was added increasing amount of potassium iodide from 0.01 uM to 100 uM and measurement of I was performed in 5 replicates at each dose level. The recovery experiment was performed in the same batch of samples. The mean percent recovery over the range tested varied from 91% to 112% (Table V). 4) Precision The within assay variance was tested by performing 5 replicate analysis of 3 urine samples, one sample with baseline I level; and 2 samples following I supplementation. For the between assay variance, these 3 urine samples were measured on 5 consecutive days. The coefficient of variation was higher for between assay than within assay, with a range of 5.7 to 10.5% for within assay and a range of 10.5 to 18% for between assay precision (Table VI). B) Practicability As previously mentioned, the practicability of an assay depends on the degree of skill required to perform it, the time involved in its performance and the cost of the assay. 1) Skill First, we should mention that the Clinical Laboratory Improvement Amendments of 1988 (CLIA) defined two categories of complexity for laboratory test: Moderate complexity and high complexity testing. The ISE method is only 20 years old and is used currently in University and Research laboratories, and rarely in clinical laboratories. For example, Doctor’s Data Inc. performs urinary fluoride levels by the ISE method and it is classified as high complexity testing mainly because the ISE procedure is not widely used in the clinical context, at least, not in the USA. It is likely that with increased applications to clinical testing, the ISE method will be downgraded to moderate complexity. Obviously, familiarity with laboratory equipment such as vacuum manifold, solid phase extraction and potentionmetric measuring devices is a basic requirement for the analyst involved in ISE measurement. Although no special skill is required for implementation of this procedure in a physician’s office, meticulous attention to cleanliness, awareness of the possible sources interference and consistency in the performance of the ISE method are qualities that the technician involved in ISE measurement must have. A clearly written protocol and well defined guidelines of quality control should not be difficult to comply with, mainly in a clinic laboratory already approved for moderate complexity procedures. 2) Time involved Vacuum manifolds are available from Applied Separations Inc., with 30 positions, so that chromatography of 30 samples could be performed in one batch. The ISE measurement of iodide is relatively rapid, usually less than 5 minutes per sample. This procedure lends itself to automation and equipments are commercially available for this purpose. We have just acquired a new model from Thermo Orion, the #960 Meter with a 45 position Autosampler. This minimizes human intervention and therefore human error. It is of interest to note that using the 960 Model, the sensitivity is calculated by proprietary software in the unit, without human intervention. Surprisingly, the computed sensitivity for I determination, using the same electrode was 0.006 mg/L, the same value we obtained, as described previously with the model 720 A-Plus meter. The upgrade from semiautomation to full automation could be justified with increased number of samples, such as in a Polyclinic or commercial laboratory. 3) Cost The 720 A Plus meter, with iodide-selective electrode and printer; the 30 position vacuum manifold; the computerized vacuum pump, plus the usual laboratory glassware and pipetting devices, would require an initial investment of $5000.00. We are currently preparing a list of equipments and other items necessary to get started in a physician’s office laboratory already approved by CLIA for moderate complexity testing. Check with local CLIA representative and your clinical pathologist for the requirements. VII. Discussion A) Methodology Since the discovery of iodine/iodide in the early 1800’s, the measurement of this element has progressed steadily from colorimetry to the present mass-spectrometry. In the USA, the starch-iodide reaction was the detection method in the 1930’s (31), replaced with the ceric ion-arsenious acid of the 1940’s (32). This last procedure is still used today in most clinical laboratories, where it has been automated (22). The 2 latest additions over the last 20 years have been the ISE method (20,21,23,24); and ICP-M.S. recently introduced in some clinical laboratories. The advantage of ICP-M.S. is the ability to measure a large number of elements in the same biological sample. Its disadvantage is the astronomical cost of acquisition and maintenance. The ISE procedure for iodide is very simple, using non-toxic reagents, and yielding results within minutes. In Japan, the ISE method can be used directly in urine samples (20,21). However, in the USA, the level of sensitivity of the ISE assay, if used directly, is 100 times lower than urine I levels usually present in the U.S. population. Recently, the availability of SAX resin, with the purity required for purification of very low levels of iodide, made it possible to apply the ISE method to the measurement of urinary I levels in the U.S. population. To our knowledge, this is the first time the purification of biological fluids on SAX columns, followed by measurement of iodide by the ISE method, is reported. Ideally, all equipment, supplies and reagents needed for the ISE assay of urinary I levels should be available from one source and this will most likely happen with increased demand. There is a need for a central laboratory capable of supplying urine samples with known amounts of iodide in order to monitor the precision and accuracy of the assay of urinary iodide in the physician’s office and in commercial laboratories. We are concerned about the great discrepancy observed with values of urinary I levels reported by commercial laboratories using the same procedure, ICP-M.S. Samples from the same urine collection were mailed to Doctor’s Data and to Mayo Medical Lab (Wilmington, Mass). The value reported by Doctor’s Data was 11 mg I/24 hr, but Mayo Medical reported 99 mg I/24hr, for the same sample, a nine-fold difference. B) Clinical applications It is estimated that a third of mankind suffers from I deficiency, defined by the World Health Organization as urinary I levels below 0.05 mg/L (1). However, I sufficiency to prevent simple goiter, and cretinism was considered adequate. I sufficiency of the whole human body has never been studied. Based on a review of published studies, we previously proposed that an amount of I about 100 times the RDA would be required for I sufficiency of the whole human body (13, 30). Using this new definition of I sufficiency, only mainland Japanese consume adequate levels of I, with 99% of the world suffering from I deficiency. There is a great need for a simple test to assess I sufficiency of the whole human body. The I loading test mentioned in this manuscript, using 3 tablets of IodoralÒ, may be adequate in a clinical setting. Correlation of % I retained with clinical improvement of such conditions as FDB could be used to fine tune this I-loading test. Ghent et al (5) have suggested that the amount of I needed in women was dependent on their body weight. The preliminary data presented in this manuscript suggest that breast size and pathology may also play an important role in I requirement by the whole human body. 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