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Dental Amalgam and the FDA
After years of debate and stalling, the US Food and Drug Administration moved elemental mercury and dental amalgam from the Class I (low risk) device category into Class II (moderate risk) on July 28, 2009. Amalgam consists of 40% to 50% mercury, 25% silver, and a 25% to 35% mixture of copper, zinc, and tin. Class II devices, unlike those in Class I, have product warnings. FDA now warns against using dental amalgam in people with known mercury allergy. The agency has also acknowledged that mercury vapor, released by dental amalgam, can have negative health effects; and it urges dental professionals to "use adequate ventilation when handling dental amalgam." FDA does not address mercury vapor's ongoing effect on patients. Rather, it asserts, "While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients." Unlike the FDA, the US Environmental Protection Agency considers mercury an extremely hazardous neurotoxin.

As part of this years-long amalgam-safety debate, US government agencies, including the National Institutes of Health, FDA, Centers for Disease Control (CDC), and the Public Health Service, asked the nonprofit Life Sciences Research Organization (LSRO) to conduct a literature review of studies that examined dental amalgam's health effects. The LSRO evaluated peer-reviewed scientific literature published between January 1, 1996, and December 31, 2003. One of the conclusions in its final report, released December 2004, addressed evidence that mercury vapor from amalgam filings is absorbed by the human body: "Numerous studies have demonstrated a positive correlation between the number of dental amalgam restorations or surfaces and urine mercury concentrations in non-occupationally exposed individuals." Urine concentrations show how much mercury is being excreted, but such measurements do not indicate how much mercury is being stored in body tissue. The warning about mercury hypersensitivity (allergy) also comes from the LSRO report.

While the FDA incorporated these two items in its reclassification, the agency chose to ignore another fact: "Inorganic mercury in the placenta, maternal blood, and cord blood correlate with maternal dental amalgam load." The LSRO was unable to find reliable published evidence that proved or disproved the hypothesis that mercury from dental amalgams harmed pregnant women or their infants. The LSRO report, however, does refer to animal experiments in which exposure to high levels of mercury vapor lead to behavioral deficits in offspring. Data involving low exposure levels and human offspring don't exist. Such studies will be difficult to perform because of ethical considerations. Choosing to err on the side of safety, Germany, Austria, and Canada have ruled against using mercury amalgam fillings in children and pregnant women as well as people with metal hypersensitivities and/or renal failure. In contrast, the US government chose to interpret lack of evidence as supporting amalgam safety. The CDC's website refers to the LSRO report with only one-half of the picture: "A recent review conducted for the USPHS in 2004 found 'insufficient evidence of a link between dental mercury and health problems, except in rare instances of allergic reaction.'" In reality, the report's Executive Summary says that the hypothesis that dental amalgam causes adverse health effects cannot be "definitively supported or refuted" because of "various important research gaps."

Mercury amalgam use has environmental consequences that affect the entire planet, not just individuals with the fillings. Even if dental clinics dispose of amalgam waste and old fillings like other hazardous waste (and many do not), human carriers are a worrisome source of mercury pollution. Mercury from amalgams ends up in the air during sludge (sewage) incineration and cremation. It gets buried in landfills or spread across farm land in the form of sewage-derived fertilizer. Perhaps most importantly, mercury excreted in urine gets flushed down the toilet and ends up in waterways. Bacteria in the water converts elemental mercury into highly toxic methylmercury, which then bioaccumulates in fish, particularly larger fish. In 2008, medical officers of the Faroe Islands (located between Scotland and Iceland) declared pilot whales, a traditional food for islanders, unfit to eat because of high mercury, PCBs, and DDT content in the meat and blubber. "[M]ercury, especially, causes lasting damage, including damage to fetal neural development and immunity in children, high blood pressure, increased rates of Parkinson's disease, circulatory problems, and possibly infertility in adults," according to NewScientist. Because of environmental concerns, both Sweden and Denmark have banned industrial use of mercury-containing materials, including amalgams.

At a Costa Mesa (California) City Council meeting, Dr. James Rota said: "'Dentists were taught in school that when you mix silver, tin, zinc and copper with mercury, you have an inert, stable mass. However, new technology now reveals that this isn't true. But we didn't know that then.'" We do now. LSRO and FDA admit that amalgams release mercury vapor. Amazingly, US government agencies continue to dodge the health significance of this fact.

Centers for Disease Control and Prevention. Dental amalgam use and benefits [Web page]. http://www.cdc.gov/oralhealth/publications/factsheets/amalgam.htm. Accessed November 2, 2010.
Life Sciences Research Organization. Review and analysis of the literature on the health effects of dental amalgam: executive summary [Web document]. December 2004. www.lsro.org/presentation_files/amalgam/amalgam_execsum.pdf. Accessed November 2, 2010.
Rota D. Historic resolution adopted by Costa Mesa: official position taken to ban dental mercury fillings [online press release]. PRWeb. October 26, 2010. www.prweb.com/releases/2010/10/prweb4334324.htm. Accessed October 28, 2010.
Toxic whales off the menu. NewScientist. December 6, 2008;6.
U.S. Food and Drug Administration. FDA issues final regulation on dental amalgam [online press release]. July 28, 2009. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm. Accessed October 25, 2010.

Bi-Digital O-Ring Test
Who would have thought that a simple diagnostic test based on finger strength would be supported by enough evidence to gain a patent? The Bi-Digital O-Ring Test (BDORT) was discovered by Dr. Yoshiaki Omura MD, ScD, in 1977. Omura, who has degrees in electrical engineering and in medicine, became aware of the Applied Kinesiology Dysfunction Localization Principle in which touching a dysfunctioning body area causes a large muscle (often in the arm) to weaken. While researching brain circulation, pathological tenderness, and the hand's grasping force, Omura became convinced that finger muscles were particularly useful for locating and diagnosing physical dysfunction. He applied for a patent in 1985, stating, "It is the primary object of the present invention to provide a method which permits imaging of internal organs, localizing exact organ representations at the front and back of the body of a patient and to provide significant diagnostic capabilities." The US Patent Office issued the patent in 1993.

To perform BDORT, the person being examined forms an O-ring – a "fairly perfect circle" – by touching the tip of the thumb to the tip of one finger on the same hand. The choice of finger depends upon its ability to resist force from the examiner. The examiner creates two circles that intersect with the O-ring by inserting his/her two index fingers in the O-ring and closing each circle with the thumb tip from the same hand. The examiner tries to pull the patient's O-ring apart, using a relatively fast speed (over 5 cm/sec) while the patient resists. The BDORT website (www.bdort.org) gives detailed instructions for determining which fingers to choose in order to achieve balanced strength between examiner and examinee.

Omura defines BDORT as "mostly an electromagnetic resonance test." Omura discovered that when a patient held a minute sample of a pathogen or a slide of a cancer cell in one hand, the O-ring formed by the patient's other hand would suddenly weaken when tested if the sample matched a pathogen or cancer in the patient's body. He hypothesizes that resonance between the electromagnetic vibrations of the sample and the matching vibration within the body produces muscle weakness. Later, Omura began using Integrinα5β1 to screen for many cancers and precancers. BDORT's accuracy has been substantiated with standard medical tests. In some cases, BDORT indicated cancer, but standard tests found no disease. Omura recommended that laboratory tests be repeated periodically as some patients developed cancer 3 to 7 years later. In addition to being a diagnostic tool, BDORT can locate organ dysfunction (i.e., location of kidney stone), determine drug and/or supplement compatibility and dosage, screen for pathogens and for allergies, and work as an imaging technique. Two 30-minute documentaries, produced by Tokai Television (Nogoya City, Japan) in 1992, demonstrate BDORT's clinical use. The documentaries are posted online at
http://www.bdort.org/BiDigitalORingTestPages/Hallmark.shtml.

Chifuyu Takeshige, MD, ScD, professor emeritus, Showa University School of Medicine, offers a possible explanation for BDORT's sensitivity to resonating substances. He notes that BDORT does not work in patients with pineal cancer or when the patient's eyes are closed, indicating that the pineal gland may be involved. Some neurons in the pineal gland respond to light. Others respond to magnetic field exerted by external qigong, which is known to inhibit N-acetyl-serotonin-transferase and the formation of serotonin. Takeshige suggests that electromagnetic resonance may also cause a decrease in serotonin in the pineal and brainstem raphe nucleus, which controls involuntary muscle tone. "If serotonin contents of the pineal gland change depending upon the grade of resonance," Takeshige writes, "and if the effect of serotonin in raphe nucleus to the extensor γ-motor neuron system [which involuntarily regulates muscle tone] is different from that to the flexor γ-system, the total muscle tone of the finger muscles making O-ring should be changed during BDORT."

Henock A. Bi-Digital O-Ring Test – historical perspectives corroboration of discoveries using the Bi-Digital O-Ring Test, with current research from Western scientific journals [Web document]. Dr. Ria Radio. www.drriaradio.com/uploads/Bi-Digital_O-ring_Test.pdf. Accessed October 20, 2010.
Muteki T, Tanikawa K. Muscle force measurement for the Bi-Digital O-Ring Test using a computerized electro-mechanical system [abstract]. Available at: www.bdort.org/BiDigitalORingTestPages/QuestionsandAnswers.shtml. Accessed October 20, 2010.
Omura Y. Bi-Digital O-Ring Test for imaging and diagnosis of internal organs of a patient. US Patent No. 5,188,107 February 23, 1993 [online document]. Dr. Ria Radio.  www.drriaradio.com/uploads/Bi-Digital_O-ring_Test.pdf. Accessed October 20, 2010.
———. Non-invasive & quick diagnostic method using the Bi-Digital O-Ring Test resonance phenomenon between two identical substance [online document]. Dr. Ria Radio.  www.drriaradio.com/uploads/Bi-Digital_O-ring_Test.pdf. Accessed October 20, 2010.
———. Transmission of molecular information on molecular structures and amounts of the molecules through the recorded traces of photons, sound waves, and electric currents coming through biological tissue and their clinical application for new non-invasive diagnosis and treatment of intractable medical problems [online document]. Dr. Ria Radio. www.drriaradio.com/uploads/Bi-Digital_O-ring_Test.pdf. Accessed October 20, 2010.
Takeshige C. A Possible mechanism of Bi-Digital O-Ring Test (BDORT) – Concept of the Association of the Pineal Gland in BDORT [abstract]. Available at  http://members.at.infoseek.co.jp/MOHKI/4thSympoEng/Mechanism.htm. Accessed October 20, 2010.
The formation and basis of the Bi-Digital O-Ring Test. June 2, 2008. http://www.baobab.or.jp/~oring/e_basis.shtml. Accessed October 20,2010.
Wikipedia article clarification [online]. BDORT. www.bdort.org. Accessed October 20, 2010.

Biological Transmutations
How can living organisms contain more of certain elements than they consume or absorb from the environment? The algae Laminaria can make iodine from iodine-free water. Chickens and guinea hens, deprived of calcium, lay soft-shelled eggs, but the eggs regain their hard shells when the birds are exposed to potassium-rich mica. Seeds germinated only in Evian water (with 0.39 milliliters of potassium) contain 16.67 milligrams of potassium compared with 6.97 milligrams in the control, nongerminated seeds. What's the origin of that extra 9.31 milligrams of potassium?

French researcher Louis Kervran spent decades investigating this biological transmutation. He showed that living organisms – plants, animals, humans – routinely transform light elements into other light elements. For example, potassium plus hydrogen convert to calcium, nitrogen plus magnesium convert to potassium, and phosphorus and hydrogen convert to sulfur. Professor Pierre Baranger, chief of the Laboratory for Organic Chemistry at the École Polytechnique (Paris, France) also investigated biological transmutation, repeating many of the seed growth experiments performed by chemist Albrecht von Herzeele (conducted and published from 1876 to 1883). By comparing ashes of seeds sprouted in distilled water with ashes of nongerminated seeds, von Herzeele found elements in sprouts that were not present in the seeds alone.

 The type and amount of transmutation depend upon the plant and upon the germinating medium. Ryeseed is great at making potassium, if the germinating medium contains magnesium. Oats are better at producing calcium. Although Kervran performed numerous animal experiments, he eventually focused on oats' production of calcium while germinating in a hydroponic culture medium of synthetic water (hydrogen and oxygen only) or double-distilled water. Simplifying the variables was his way of addressing skeptics who refused to accept the possibility of biological transmutation.

How do these elements transmute? Kervran hypothesized that transmutation results from weak energy interactions of atomic nuclei in these lighter elements (as opposed to the heavy elements used in nuclear fission or fusion). These energy interactions are regulated by the metabolism of germination and growth. Hormones and enzymes apparently have a role. Kervran reported that the hormone aldosterone in conjunction with cortisol regulates the transmutation of sodium into potassium. Thyroid hormones appear to govern the calcium/potassium ratio. A May 1978 report, written by S. Goldfein for the Army Mobility Equipment Research and Development Command (Fort Belvoir, Virginia), suggests that Mg adenosine triphosphate in the cell's mitochondria may provide the energy for transmutation. Goldfein's abstract states: "It was concluded that elemental transmutations were indeed occurring in life organisms and were probably accompanied by a net energy gain."

Addressing mineral deficiencies with supplementation becomes greatly complicated when biological transmutation gets figured into the equation. Kervran's book Biological Transmutations (1966, 1972, 1998) warned against supplementing certain minerals, present in low levels in blood or hair, says Lawrence Wilson in his book Hair Mineral Analysis. The body would probably transmute them, causing an even greater imbalance. We assume that a mineral deficiency is due to low intake of that mineral. What if it is due to an underlying hormone or energy imbalance that has skewed the body's transmutation process?

Goldfein S. Energy development from elemental transmutations in biological systems. May 1978. Available at: http://oai.dtic.mil/oai/oai?verb=getRecord&metadataPrefix=html&identifier=ADA056906
Accessed November 11, 2010.
Kervran L. Biological transmutations and modern physics. Paris: Maloine S.A; 1982. Available at: www.rexresearch.com/kervran/kervran.htm. Accessed October 19, 2010.
Life Enthusiast Co-op. Biological transmutations. Available at: www.life-enthusiast.com/index/Articles/Kervran/Biological_Transmutations. Accessed October 19, 2010.
McLean A. Some notes on the work of Louis Kervran. Hermet J. 1981. Available at: www.levity.com/alchemy/kervran.html. Accessed October 19, 2010.
Mallove E. Book review: Biological Transmutations by C. Louis Kervran. Infinite Energy. November/December 2000. Available at: www.infinite-energy.com/emagazine/issue34/bookreview_biotrans.html. Accessed November 11, 2010.
Puri M. Evidence that atoms behave differently in biological systems than outside of them [online article]. KeelyNet. October 1, 1997. www.keelynet.com/biology/bioxmute.htm. Accessed October 19, 2010.

Genetic Testing
In July 2010, the FDA convened a public hearing on regulating genetic diagnostic tests that screen for disease factors, particularly direct-to-consumer disease tests. (The FDA is less concerned about at-home paternity tests because these tests, unlike those screening for disease, provide simple yes/no results.) Medical providers use genetic tests to screen fetuses for genetic conditions (e.g., Down's); to assess a couple's risk of passing a serious genetic condition on to their children; to diagnose patients with symptoms of an inherited disease; and to find out if nonsymptomatic persons have inherited genes that predispose them to a genetic illness. New tests screen genetic variants in the cytochrome P450 pathway, which breaks down chemicals (including drugs and herbal medicines). These tests are supposed to help doctors and pharmacists predict which drugs will be most effective and have the least negative reactions. "'Today there is no mechanism to ensure that genetic tests are supported by adequate evidence before they are marketed or that marketing claims for such tests are truthful,'" stated Johns Hopkins University researchers in an April 2008 article published in Science.

At this point in time, all genetic tests have largely unrecognized limitations. First, these tests look for a limited number of specific disease-associated genetic variants. Some conditions are caused by multiple variants, and many tests do not screen for all possibilities (as in cystic fibrosis). Second, genetic tests cannot predict whether disease will actually occur, nor can they predict the severity if disease does develop. Lifestyle and environmental factors often determine how genetic variants will be expressed. Consequently, using genetic tests alone to predict one's risk for getting a disease with accuracy is very difficult. Direct-to-consumer test accuracy is particular questionable since "… the vast majority of variants covered by DTC genetic tests are of extremely low predictive value," according to T. Caulfield et al. Moreover, many DTC tests have not been clinically evaluated. Genetic test manufacturers contend that their tests will motivate genetically susceptible people to make beneficial lifestyle changes. Available evidence does not support this view. A 2008 study of published meta-analyses and HuGENet (Human Genome Epidemiology Network) reviews stated that the "'scientific evidence for most associations between genetic variants and disease risk is insufficient to support useful applications.'" If a genetic test can accurately banish worry of an inherited disease, the test is well worth it. But if the test is inaccurate?

As the DTC genetic test industry grows, doctors will be put in the difficult position of helping patients interpret these tests. T. Caulfield et al. report, "A recent Internet based survey by McGuire et al. in the United States (n = 1087) found that 78% of those individuals who considered using genetic testing services would ask their physician for help interpreting test results. In other words, despite the still questionable utility of these tests, patients will likely take results to their physicians, thus increasing the pressure on an already overburdened healthcare system."

Despite all the hype, present-day genetic tests do not have the accuracy to individualize health information. "The authors [of the HuGENet review and meta-analyses] suggest 'it could take years, if not decades, before lifestyle and medical interventions can be responsibly and effectively tailored to individual genomic profiles."

American Association for Clinical Chemistry. The universe of genetic testing [online article]. Lab Tests Online. www.labtestsonline.org/understanding/features/genetics.html. Accessed October 19, 2010.
Caulfield T, Ries NM, Ray PN, et al. Direct-to-consumer genetic testing: good, bad or benign? Clin Genet. 2009. Available at: www.law.ualberta.ca/centres/hli/userfiles/file/DTC%20Genetic%20Testing%20-%20good%20bad%20or%20benign.pdf. Accessed October 19, 2010.
Cortez MF. Gene tests may be more confusing than illuminating. Bloomberg.com. April 7, 2008. Accessed April 7, 2008.
Dooren JC. FDA weighs rules for consumer genetic tests. Wall Street Journal. July 19, 2010. Available at: www.online.wsj.com. Accessed November 11, 2010.
Malcolm R. DNA paternity tests seem to slip out of FDA regulation [online article]. USA Live Headlines. October 23, 2010. www.usaliveheadlines.com/1569/dna-paternity-tests-seem-to-slip-out-of-fda-regualtion.htm. Accessed November 11, 2010.
What is drug reaction testing [Web article]. Genelex. www.healthanddna.com/dna-learning/faq-drug-safety-drug-reaction.html. Accessed April 7, 2008.

The Specter of Ghostwritten Studies
The use of ghostwriters – uncredited contributors to a published article – is not new. Like conscious and unconscious manipulation of study data and design, ghostwriting has been one of the hidden skeletons in the research closet. Recent lawsuits against pharmaceutical companies have uncloaked their widespread use of ghostwriting companies, also known as medical communications firms. These companies are charged with getting drug-favorable articles into prestigious journals. They are hired to write deliberately biased articles masquerading as science.

On September 7, 2010, PLoS Medicine published an analysis, performed by Georgetown University researcher Adriane Fugh-Berman, of about 1500 e-mails, contracts, and other documents. She became aware of the documents while acting as a paid expert witness for plaintiffs suing the pharmaceutical company Wyeth for damages reportedly caused by its hormone replacement therapy Prempro. (Wyeth was bought by Pfizer in 2009.) The New York Times and PLoS got the court's permission to release the documents to the public. (Thousands of other documents remain sealed.) According to the released documents, the communications firm DesignWrite wrote, edited, and "oversaw the publication of dozens of peer-reviewed articles, conference abstracts and posters on HRT, receiving up to $25,000 per project" from Wyeth from 1997 and 2003. Sometimes, a study's named authors provided little input. The ghostwritten articles gave little weight to epidemiological data that linked HRT to breast cancer and questioned the effectiveness of competing generic hormone treatments. The articles also encouraged off-label use of HRT, suggesting to doctors that HRT could protect against Alzheimer's and Parkinson's diseases, improve skin, and increase life quality. Pharmaceutical firms are not permitted to include off-label uses (uses other than those approved by FDA) in their advertising. Off-label uses evolve from research. DesignWrite, however, is a communications, not a research, firm. Their product is public relations, not honest communication.

Not surprisingly, a Pfizer spokesman criticized Fugh-Berman's analysis, saying it "'completely – and conveniently – ignores the fact that the published manuscripts were subjected to rigorous peer review by outside experts on behalf of the medical journals that published them.'" A quick trip to Google Scholar will uncover numerous articles about the shortcomings of the peer-review process. As David H. Freedman says in his article "Lies, Damned Lies, and Medical Science," "The ultimate protection against research error and bias is supposed to come from the way scientists constantly retest each other's results – except they don't. Only the most prominent findings are likely to be put to the test, because there's likely to be publication payoff in firming up the proof, or contradicting it."

Wyeth's use of DesignWrite to promote Prempro is the latest in a growing list of ghostwritten promotional campaigns. GlaxoSmithKline used a ghostwriting program called CASPPER to mimic the writing styles of professors and researchers whose names then appeared on positive articles about its antidepressant Paxil. The articles appeared in medical journals such as American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry. Over half of the journal articles about Zoloft during the late 1990s came from a medical communications firm hired by Pfizer. Ghostwriters also promoted Vioxx. Its manufacturer Merck voluntarily pulled the anti-inflammatory from the market in 2004, because of increased risk of heart attacks and strokes. "'How many other drugs have been promoted in the same way, but you never find out about them because nobody's suffered heart attacks?'" asked medical ethicist Leemon McHenry in article for Scientific American. "'Nobody finds out about this at all until there's been some major damage and the lawsuits get filed.'" Such outright deception has some people questioning the veracity and reliability of any drug study, peer-reviewed or not.

Callaway E. Questions over ghostwriting in drug industry. Sci Am. Sept. 7, 2010.Available at:  http://www.scientificamerican.com/article.cfm?id=questions-over-ghostwriting-in. Accessed October 19, 2010.
Elliott C. Walk it off, crybaby [blog entry]. Hastings Center Bioethics Forum. October 13, 2010. www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4931&blogid=140&blogid=140. Accessed October 20, 2010.
Freedman DH. Lies, damned lies, and medical science. Atlantic. November 2010. Available at: www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269. Accessed October 25, 2010.
Gøtzsche PC, Kassirer JP, Woolley KL, et al. What should be done to tackle ghostwriting in the medical literature? PLoS Medicine. February 2009;6(2). Available at: http://medicine.plosjournals.org/archive/1549-1676/6/2/pdf/10.1371_journal.pmed.1000023-S.pdf. Accessed January 3, 2010.
Lane C. Ghostwriting and medical fraud [blog entry]. Psychology Today: Side Effects. October 16, 2010. www.psychologytoday.com/blog/side-effects/201010/ghostwriting-and-medical-fraud. Accessed October 19, 2010.

… it is interesting to note that an essential secret in the practice of NBM is to keep muscles of our body in a completely relaxed state. If the hand of the emitter is stiff, ki will not be emitted. Can our skeletal muscle serve as a "light resonator?" It has a repeating striation of about 2500 nm, and the length of the thin filament (actin-filament) is 1000 nm. If these repeating structures of the skeletal muscle could cause the production of a standing wave with a wavelength of 1000 nm, it may enhance the "laser" radiation.

Ohnishi ST, Ohnishi T. How far can Ki-energy reach? – a hypothetical mechanism for the generation and transmission of Ki-energy. eCAM. 2009;6(3):379–391. Available at: http://ecam.oxfordjournals.org/cgi/content/full/6/3/379. Accessed November 11, 2009.

Live Blood Analysis
Is live blood analysis (LBA) a legitimate diagnostic method or quackery? It depends upon who is using it and for what purpose. LBA uses a dark-field microscope to view fresh blood samples, in itself an uncontroversial process. Dark-field microscopes "do not differ substantially from microscopes already approved by the FDA for other diagnostic purposes," according to an US Office of Inspector General report. The controversy lies in the interpretation. Some practitioners use it to monitor the biological terrain. Some websites, which may or may not be run by a health practitioner, claim without substantiation that LBA can show the presence of specific diseases that can be remedied with supplements available at their site.

In dark-field microscopy, light shines from the side so that particles and objects on a slide reflect the light. As a result, the objects appear bright white against a dark background. The benefit of dark-field microscopy is that the resolution and contrast are better than bright-field viewing (in which light is shown through the slide) and less expensive than phase contrast. Phase contrast microscopes convert tiny phase shifts in light into contrast imaging as the light passes through a specimen. Like dark-field microscopy, phase contrast does not require the use of stains that kill cells. David R. Caprette at Rice University says, "Any time you wish to view everything in a liquid sample, debris and all, dark field is best. … Dark field is especially useful for finding cells in suspension [e.g. blood]." G. A. Jamjoom reported in 1983 that dark-field microscopy was useful for detecting differing forms of malarial parasites in unstained blood films: "The technique offers the distinct advantages of rapid diagnosis, increased sensitivity, and adaptability to field work."

While dark-field microscopy is an accepted tool, LBA is considered an "unestablished" laboratory test. In 2001, the US Office of Inspector General (OIG) published a report about the Centers for Medicare and Medicaid Service's ability to regulate laboratories conducting live blood cell analysis and other unestablished laboratory tests. All laboratory testing, including LBA performed in doctors' offices, should conform to the 1988 Clinical Laboratory Improvement Amendments (CLIA), according to the Office of General Counsel. This law set up quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results. Centers for Medicare and Medicaid Services is responsible for implementing CLIA.

Most of the 200 laboratories offering LBA, identified for the OIG report, did not have a CLIA certificate. Some doctors offering LBA "believe that LBA falls within the scope of their license to practice medicine and that it should not be regulated under CLIA" since Medicare does not pay for these tests. Other practitioners say they use LBA for research purposes only, which exempts a test from CLIA if patients are not informed of the test's results. "Most providers of unestablished tests with whom [OIG] spoke would like to be regulated by their peers and not by the CLIA program," says the OIG report. These providers would like to have "some checks and balances to protect the public from unscrupulous providers."

Like many other holistic CAM and integrative practices, however, LBA does not fit conventional medicine's reductionist paradigm that, rightly or wrongly, defines a "normal" range for isolated factors. Even physicians who operate laboratories that meet CLIA requirements for performing moderate and high complexity testing were unable to meet CMS requirements that would validate LBA as a precise, analytically sensitive test with established reference ranges. While LBA can provide useful information, it cannot accurately diagnose cancer. In 2005 German study, a health practitioner with several years of training in dark-field microscopy according to Enderlein examined the blood of 110 subjects. The practitioner correctly identified 3 of 12 patients with cancer in the group. The authors conclude: "Analysis of sensitivity (0.25), specificity (0.64), positive (0.09) and negative (0.85) predictive values revealed unsatisfactory results." Just because LBA is unreliable in diagnosing cancer doesn't mean that it isn't useful in other ways. The dark-field pictures that Majid Ali, MD, has shared in past issues of Townsend Letter and the pictures in Beverly Rubik's Weston Price diet study give objective information about a person's biology. At the very least, LBA can give skilled practitioners a easy way to evaluate overall terrain and to monitor progress. Contrary to assertions by the quackbusters, the OIG report doesn't condemn the use of LBA: "Nothing in this report should be construed as an endorsement or condemnation of any laboratory test."

The primary concern about LBA, according to the CDC, is the "potential harm that might occur when providers fail to recognize seriously ill patients." This concern is a realistic problem if LBA practitioners have little medical training, relying only on a correspondence course to interpret blood samples in order to sell products. For trained holistic practitioners, however, LBA may be a valuable assessment tool.

Caprette DR. Dark field viewing [Web page]. Rice University Introduction to Experimental Biosciences. www.ruf.rice.edu/~bioslabs/methods/microscopy/dfield.html. Accessed October 19, 2010.
El-Safadi S, Tinneberg HR, von Georgi R, et al. Does dark field microscopy according to Enderlein allow for cancer diagnosis? A prospective study. (English abstract, article in German.) Forsch Komplementarmed Klass Naturheilkd. June 2005;12(3):148–151. Available at: www.ncbi.nlm.nih.gov/pubmed/15985779. Accessed October 19, 2010.
Jamjoom GA. Dark-field microscopy for detection of malaria in unstained blood films.(abstract) J Clin Microbiol. May 1983;17(5):717–721. Available at: www.jcm.asm.org. Accessed October 19, 2010.
Office of Inspector General, US Department of Health & Human Services [online document]. CLIA regulation of unestablished laboratory tests. July 2001. www.oig.hhs.gov/oei/reports/oei-05-00-00250.pdf. Accessed October 19, 2010.
Rubin ZA. Live blood analysis: new diagnostic method or quackery? Proc UCLA Healthc. 2009;13. Available at www.med.ucla.edu/modules/wfsection/article.php?articleid=420. Accessed October 19, 2010.

Diet's Effect on Blood
What effect does consuming a whole-foods diet as outlined by the Weston A. Price Foundation (WAPF) have on blood? Beverly Rubik, PhD, explored that question in a pilot study that compared the blood of eight healthy adults, ages 30 through 83 (mean age 51.12), who had been on the WAPF diet for at least two years (mean 7.5 years) with blood taken from six age-matched healthy adults on a conventional diet. Like those in the WAPF group, the controls were not obese and did not smoke or take prescription drugs. Their conventional modern diet included some organic foods and dietary supplements.

The WAPF diet is based upon research by Weston A. Price, DDS, who studied traditional diets and dental health of people in secluded areas around the world during the 1920s and 1930s. The hallmark of traditional diets is the use of unprocessed whole foods and healthful dietary fat. (Detailed guidelines are available at www.westonaprice.org.) WAPF diet subjects avoid processed liquid vegetable oils, partially hydrogenated oils, refined sugars, corn syrup, and pasteurized milk. (Five out of eight drank raw milk instead.) In addition, WAPF subjects included a high amount of saturated fat in their diets, consuming 5 to 14 eggs or egg yolks each week (except for one person with egg allergy) and 3 to 15 tablespoons of saturated fats per day (mean 7.375 tablespoons/day). Less than 5% of their diet came from conventional restaurant food. Seven WAPF subjects regularly ate fermented foods rich in probiotics, and all eight usually prepared grains and nuts by soaking or using sourdough, as advocated in Sally Fallon's book Nourishing Traditions. Six WAPF subjects also supplemented with cod liver oil.

Rubik used dark-field microscopy to take numerous blood microphotographs and short video clips over a 45-minute period of each participant's blood sample. Samples were taken after five hours of fasting. (Water was permitted during the fast period.) Dark field microscopy of blood samples, also known as live blood analysis (LBA), shows the size, shape, and cellular integrity of red blood cells (RBCs) and the presence and movement of white blood cells. LBA also shows platelet aggregates, fibrin, microbes and parasites, and particulates (i.e., cholesterol, crystals, and contaminants).

Rubik assessed clotting and inflammation factors (RBC stickiness, Rouleau and other RBC aggregates; platelet activation and aggregation; fibrin, spicules, and shape changes in RBCs), using a five-level Likert scale (0 = most desirable and 4 = least desirable). Clotting and coagulation processes are related to inflammation. Seven of the eight WAPF subjects had coagulation scores of 1.0 or less. All six controls had scores of two or more. Rubik did not perform a statistical analysis because of the small sample size. She says: "This preliminary study indicates that the consumption of large amounts of saturated fat does not adversely affect blood cell integrity and clotting or inflammation factors. In fact, we observed just the opposite, namely, that high levels of saturated fats in the diet seem to have a protective effect on the RBCs and to inhibit the expression of inflammation."

The study, of course, is limited by the small number of participants and limited samples and by the qualitative nature of live blood analysis. LBA is not accepted by mainstream medicine. Dark-field microscopy, however, is an accepted (though rarely used) research tool. "For any replication of this study, it is critical that testing be performed by a trained and experienced microscopist as was done in this trial," Rubik writes.

In conclusion: "Healthy food, as consumed in the WAPF diet, is all-natural, easy to digest and contains many protective elements, and does not tell our bodies to turn on the inflammatory cascade, as there is nothing offensive to fight."

Rubik B. Live blood analysis of adults comparing the Weston A. Price Foundation diet and the conventional modern diet. Wise Traditions. Winter 2009:35–43. Available at: www.westonaprice.org/health-issues/1835-pilot-research-study-live-blood-analysis-of-adults.html. Accessed November 2, 2010.