Research into the use and efficacy of UV light for treatment of disease was initiated in the 1870"s. One of the first researchers to experiment with UV light was Niels Ryberg Finsen, who won the Nobel Peace Prize for "Physiology of Medicine" in 1903 for his UV treatments of 300 people suffering from Lupus in Denmark.

Blood Irradiation ("BI/UVBI/UBI/LBI") therapy and research was initiated in the 1920s when an Ultraviolet Blood Irradiation (UVBI) device was developed for extracorporeal irradiation of the blood. By the 1940s UVBI came to be used to treat bacterial, viral, and autoimmune diseases. However, enthusiasm over the new antibiotics and vaccines in the 1950s caused the UVBI device to be placed on the shelf even though for certain indications (hepatitis, viral pneumonia, and streptococcal toxemia) UVBI treatment was demonstrably superior. In the 1970s interest in UVBI revived in Russia. At the same time, a new form of BI termed "photopheresis", which entailed triggering chemotherapy with a small dose of UVBI, was invented in the US. By the 1990s, Russian physicians were using low-intensity lasers beamed down a waveguide directly into the blood (LBI) to achieve roughly equivalent effects. The development of multidrug resistance to antibiotics in recent years and the search for less toxic therapies have led to a renewed interest in Blood Irradiation. By now, millions of patients have been successfully treated with BI and scores of clinical trials have been conducted in Russia, Ukraine, and the former East Germany. BI therapy is also used by some physicians in China and the United States.

The first person to experiment with irradiation of the blood was Kurt Naswitis, who directly irradiated the blood with UV light through a shunt in 1922. Beginning in 1923, Seattle scientist Emmet Knott, D.Sc., sought to harness in an extracorporeal way the known bactericidal property of ultraviolet rays in order to treat infectious diseases of the blood. Knott built an apparatus that would remove blood from the body through a tube, citrate it to avoid coagulation, expose it in a small chamber to calibrated UV irradiation, and then pump it through a tube back into the body.

In experiments with dogs, Knott first attempted to irradiate the entire volume of blood after infecting the dogs so as to induce severe septicemia. He found that the irradiation cleared their blood of any trace of infection, but that they all died in 5-7 days of profound depression and a progressive respiratory failure. After further experimentation in which the apparatus failed part-way through the experiment (but the dog survived without infection), Knott concluded that it sufficed to irradiate a mere 1-1/2 cc of blood per pound of body weight (about 5 percent of the total volume of blood), and that this dosage had no untoward side effects at all. Knott's notion of treating the blood with UV to destroy microorganisms was an obvious one; but demonstrating that it could be done in a safe and effective manner, as well as devising over years of careful testing a practical mode for so doing, constitute a major scientific contribution.

The first treatment with UVBI of a human occurred in 1928. The patient was a woman moribund following a septic abortion complicated by hemolytic streptococcus septicemia. Treatment with UVBI returned her to normal health within a few days. Indicative of the caution with which Knott and his medical collaborators worked, there was no further treatment of a human subject until 1933 when the device again cured a patient with advanced hemolytic streptococcus septicemia. The UVBI device then began to be used with some frequency on patients with severe bacterial septicemia and subsequently on patients with viral pneumonia.

By the 1940s several dozen physicians were regularly using the "Knott Hemo-Irradiator" according to the technique established by Knott. They treated bacterial infections, pneumonia, poliomyelitis, botulism, non-healing wounds, encephalitis, peritonitis, asthma, pelvic inflammatory disease, biliary disease, hepatitis, and many other infectious, inflammatory, and autoimmune disorders. The results of treatments included: inactivation of toxins, destruction and inhibition of growth of bacteria, increase in the oxygen combining power of the blood and oxygen transportation to organs, activation of steroid hormones, vasodilation, activation of white blood cells, stimulation of cellular and humoral immunity, stimulation of fibrinolysis, decreased viscosity of blood, improved microcirculation, stimulation of corticosteroid and mineralosteroid hormone production, and decreased platelet aggregation. In the treatment of tens of thousands of patients, the main side effect observed was a flushing of the skin. Surgeons were particularly interested in the use of UVBI pre- and post-operatively to treat infections. The American Journal of Surgery published many peer reviewed papers on UVBI therapy. Proponents of BI therapy formed the American Blood Irradiation Society and published their findings in dozens of scientific articles. Thousands of patients were treated at leading centers like Georgetown University Hospital. UVBI fared well in several clinical trials with controls, but most of the published outcome studies consisted of series of cases without controls.

UVBI was not without its scientific critics. One critical study (Moor et al. (1948)) pointed out the lack of controls and the unclear criteria for success in the articles published by BI's proponents. It also claimed that UVBI had no effect on bacteria or toxins, but that paper's own research methodology was faulty. The researchers erroneously assumed that it was the direct extracorporeal irradiation of the blood that was claimed to destroy great numbers of infectious microorganisms, whereas Knott had discovered that it was the pharmacological action of the irradiated blood upon its return to the body that was the true therapy. Likewise, in a test of UVBI's effects against overwhelming infections in rabbits innoculated with botulism, the critics used only a single dose of UVBI--not surprisingly, with no effect. Critical and derogatory articles based upon inadequate methodology and falsely restrictive criteria are a favorite way of defaming promising technology threatening to orthodox prevailing opinion in medicine.

Another critical study (Schwartz et al. (1952)) was funded in part by the American Medical Association and appeared in its Journal. Again, even though the researchers quoted Knott on the point that it was not the direct irradiation of the blood that destroyed the bacteria, but rather the effects in vivo of small, repeated doses, they proceeded to test the direct bactericidal effect of the UVBI device and found it wanting. They then tested UVBI on 68 patients with a wide range of symptoms. UVBI reduced ulcers in 5 out of 8 patients but was apparently ineffective against most of 11 cases of pelvic inflammatory disease (PID). The study had serious flaws, however. The 23 cases of hepatitis were acute ones which would presumably have resolved with or without intervention. No report was made on the effects on 7 arthritis patients, and objective improvements in various indications were glided over. Most PID patients received only 1-2 treatments, even though their cases were generally severe. In certain PID cases, the researchers turned off the device to test whether the patients would report subjective improvement (they did). But the researchers then listed these treatments as if the device were turned on. In one case, a patient listed as having three treatments apparently received no UVBI whatsoever. The researchers' scatter-gun approach on other indications was of anecdotal value only, especially since the samples were too small (often a single patient), criteria for improvement were not provided, and there were no controls. In addition, no effort was made to distinguish between the effects of UVBI on early and late stages of a disease. It is hard to avoid concluding that this study revealed more about the bias of the researchers and the AMA than it did about UVBI.

The dramatic advances in antibiotics, vaccines, and corticosteroids in the 1950s put a halt to the growing interest in UVBI therapy. Amid the enthusiasm over the new wonder drugs, only a handful of physicians continued to use blood irradiation. Even though it was illogical to set aside a therapy that could treat viral diseases (e.g., chronic hepatitis and viral pneumonia) that were impervious to antibiotics, this illogic came to pass. From 1955 until the 1990s, only a few American physicians continued to work with the UVBI device. The technique was never again taught in medical schools and training centers. It is also hard to justify the way that American medical science has overlooked the many reports of clinical trials of UVBI and LBI in Russian and East German medical journals and books over the past two decades, especially given the intense effort to identify promising approaches to the treatment of HIV and related conditions.The infusion machine did, however, receive FDA "grandfather" status as a device that was sold and distributed in interstate commerce prior to 1976 (510(k) status).

In Europe the UVBI technique enjoyed far less resistance. Czech physician Karel Havlicek and others in the 1930's began using UVBI via muscular reinjection of small doses, often just 10 ml. Federico Wehrli irradiated oxygenated blood with UV in a procedure termed Hematogenic Oxidation Therapy (HOT). Since then, HOT has enjoyed a certain popularity in Central Europe. In Germany practitioners persisted in using UVBI. By the 1980s, UVBI had become popular among East German and Russian physicians. In the 1990s, Russian physicians began to use low-intensity lasers to irradiate the blood through a fiber inserted into a vein with an IV needle (LBI). Now interest in BI has spread to the United States. The rise of multidrug resistance of strains of bacteria, concerns over the side effects of drugs, efforts to control costs, and the HIV epidemic have led medical researchers and physicians to seek to combat infectious and autoimmune diseases with innovative approaches such as UVBI and LBI.

From the early years of UVBI therapy, Knott and his associates sought to explain how BI treatment obtains its therapeutic effects. They and subsequent researchers identified two possible modes:

• The UV irradiation of the blood in the irradiation chamber destroys or alters bacteria and viruses in the extracted blood in such a way as to create a kind of vaccination effect when they return to the body. This provokes a reaction by the immune system which in turn destroys most or all of the other bacteria or virus in the body,

The lack of detailed understanding of immunology or radical biochemistry at the peak of the use of UVBI therapy in the 1940s kept researchers from determining which of these two effects is more powerful, and in which applications. It also obscured a possible third pathway: that the radiation itself, though quite modest in level, has an impact on the autonomic nervous system (hence the frequent instances of flushing of the skin) and is perceived as a threat/stimulus by the entire immune system, which springs into action and thereby contributes to destroying bacteria or virus. It is well known that bacteria and viruses are more vulnerable to UV radiation and superoxide anion radicals than are somatic cells. UVBI excites oxygen to superoxide radicals, which disrupt the DNA of microorganisms through pyrimidine dimerization and peroxidation. In contrast, as long as somatic cells have adequate oxidation-reduction enzyme protection, they have the capability of withstanding modest amounts of radiation in the blood, unless they are highly metabolically active or in rapid mitosis.
 

Knott and other early researchers noted that UVBI treatment has a complex effect on the immune system. On the one hand, UVBI stimulates the activity of white blood cells; on the other, excess amounts destroy various white blood cells. The first effect is the basis of the immune response explanation of the beneficial effects of UVBI treatment. The second suggests a reason why UVBI treatment seems so effective against autoimmune diseases. In autoimmune disorders it appears that the metabolically active T-cells and other immune cells absorb much greater amounts of radiation than ordinary body cells, and this radiation destroys them, thus slowing down or stopping the disease. Activated T-cells in particular are prone to absorb the induced secondary radiation following UVBI treatment as a source of energy just as they absorb at a very high rate glucose and other energy-bearing molecules. In effect, they are tricked by evolution. Having specialized for hundreds of millions of years within the controlled environment of the bodies of animals in the art of absorbing as much endogenous biochemical energy as possible (via the "pentose shunt" a cell can absorb over 1,000 molecules of glucose per second) to achieve the high levels of activation needed to orchestrate and drive the powerful response of cellular immunity, they are not equipped to switch to shutting out excessive energy that comes without warning from outside the body.

The remarkable specificity that UVBI treatment demonstrates can best be explained by the body's own system of shuttling energy around to the places it is needed. This effect can be seen most readily in the fulminating conditions against which UVBI has shown itself to be so formidable. These conditions, e.g., fulminant hepatitis, suck into themselves an unusually high amount of energy in the form of glucose and other energy bearing molecules. Without this energy, there could be no fulmination; and this energy is made available from system wide, not merely local, sources. As the fulmination spirals upward, the body smoothly fuels it with energy, suggesting that there is a kind of Energy Gradient in the blood, a system whereby the body supplies energy to the various processes in it on demand and, if necessary, to a far higher degree than would occur by the mere undirected circulation of energy-bearing molecules via the blood. In effect, the blood-borne secondary radiation is channeled as energy directly toward the fulmination, where it destroys the activated immune cells (or, in the case of necrotizing pancreatitis, the activated enzymes) that are driving it. In these circumstances, even amounts of radiation from UVBI treatment well over the normal dosage tend to do little or no peripheral damage, in contrast to treatment with various chemotherapies.

Another possible explanation of the effectiveness of BI treatment in the special case of liver diseases is that the blood filtering action of the liver tends to concentrate the radiation to a far higher level than the modest levels in the circulating blood. This effect would suggest that BI might be equally effective in the treatment of Idiopathic Thrombocytopenic Purpura (ITP), an autoimmune disease of the spleen, another blood-filtering organ.
 

In addition, as a fluid, the blood is capable of delivering the secondary radiation from UVBI treatment to hard-to-get-at locations in the body which other kinds of radiation cannot reach without damaging tissue. The result is higher specificity. This would explain the action of UVBI in neurological disorders such as petit mal seizures. A highly successful Russian LBI treatment of schizophrenics with depressive syndrome resistant to all drugs (dramatic improvement in 8 out of 8 cases) resulted from the ability of the irradiated blood to destroy metabolically active white blood cells blocking microcirculation in the brain, for instance (Stulin et al. (1994)). In turn, this action suggests a possible role for UVBI in the treatment of major depression as a substitute for Electroconvulsive Therapy. UVBI generation of superoxide radicals can be seen as a glucose antagonist/substitute/overrider of fermentation, and thus as a suppressor of pathological metabolic activity in the brain, or for that matter anywhere else in the body.

The literature on UVBI places a good deal of emphasis on the way it oxygenates and otherwise improves the characteristics of the blood (rheological characteristics, vasodilation, improvement in peripheral circulation). This effect occurs with unusual rapidity following transfusion of irradiated blood and can transform severely aggregated clumps of erythrocytes and platelets into normally diffuse, free-flowing arrays within minutes. Whether this effect should be considered part of UVBI's mechanism of action or rather a consequence of it, it clearly is useful in the treatment of many disorders, e.g., in achieving the gratifying results reported by Russian physicians in treating cerebrovascular, heart, and lower limb circulatory disorders. UVBI also significantly lessens venous thrombosis or pulmonary embolism (Brill (1996)). Blood oxygenation might be connected with a known side effect of UVBI treatment: the creation of ozone in the blood.

Other documented short-term effects of UVBI include: a modification of erythocyte membranes that releases substances into the blood that appear to stimulate further changes:

• Structural changes in plasma proteins (IgM can be activated up to 16 times normal)
• Activation of complement
• Immediate release of superoxide radical oxygen, followed by a rise of glutathione levels
• Expansion of blood volume and slight decline in hematocrit
• Normalization of blood pressure
• Activation of pathological clot-removing fibrinolytic factors and the reduction in the activity of coagulants
• Enhanced phagocytosis (engulfing and eating of foreign matter/debris/microbes/tumor cells) by activated macrophage cells.
• Reversal of the the suppression of the detoxifying function of the liver by toxins and drugs.

In effect, the entry of the secondary ultraviolet radiation into the blood, a dynamic, energy-bearing fluid, changes the "correlation of forces" in the body in dozens of ways that benefit the entire organism.

UVBI therapy operates in a somewhat complex manner but frequently with a surprisingly simple specificity and consequent virtual lack of side effects. In infectious diseases, the immunostimulatory effect and the induced secondary radiation work in tandem. In autoimmune disorders, the concentrated secondary radiation appears to be the main mode by which UVBI treatment obtains its effects, suggesting that even in infectious diseases it plays a much more important role than the immunostimulatory effect. The hypothesis that the focused induced secondary radiation from UVBI creates superoxide radical anions fits perfectly the pattern of effects seen with ozonized terpenes and porphyrins. UVBI is simply another method of stimulating circulating and cellular oxygen into a higher energy state as ozone, without outgassing. UVBI is the classical form of oxygenation therapy.

The accepted standard of UVBI treatment is to irradiate a small portion of the blood for a limited amount of time and to repeat this treatment at intervals that are appropriate for the disease and its intensity (e.g., 3-4 sessions spaced one week apart to treat chronic hepatitis B). It is thought that in this way any danger that might arise from irradiating the total volume of the blood or irradiating the blood with a higher intensity UV source for a longer time can be obviated. Clearly, in a fulminating condition, it might be necessary to use a higher dosage and/or to repeat the normal treatment at very frequent intervals to save the patient's life.

The standard procedure (Knott Technique) with the Russian Izolda or German Eumatron device is to withdraw 1.5 ml of blood per pound of body weight (up to a total of 250 ml) by venipuncture into a transfusion flask containing a small amount of an anticoagulant such as heparin or citrate to prevent clots in the bottle or tubing. The UV lamp should be turned on for 5-10 minutes to allow it to warm up. The blood is pumped or manually aspirated through UVBI tubing at an automatically controlled rate. The blood flows through an irradiation chamber (cuvette) where it is exposed for up to ten seconds to a controlled amount of ultraviolet irradiation in the accepted therapeutic band of UV-B and UV-C (250-270 nm.). When the correct amount has been irradiated and stored in a flask, the direction is reversed and the blood is irradiated a second time on its passage back into the body through the same needle used for withdrawal. Ozone, terpenes and porphyrins can be added during the re-infusion phase, if desired. Using gravity feed, the procedure takes about one half hour, including 10 minutes for set-up and 10 minutes for clean-up. Newer devices contain disposable crystal reaction chambers and tubing to avoid the need for washing and re-use of contaminated glassware.

As a medical device that was in interstate commerce prior to 1976, the UVBI device may be legally marketed in the United States by the original manufacturer or its lineal descendant without any claims being made regarding specific indications, according to the rules of the U.S. Food and Drug Administration (FDA). This is not the same as "FDA approval", which would require demonstrating a claim. The FDA has approved the principle that irradiation of the blood can convey therapeutic benefit. In the United States, any licensed medical practitioner is authorized to use a UVBI device. It is ideal, for instance, for use by a registered nurse within an independent practice who accepts patients referred by physicians for UVBI treatment.

Although LBI has become very popular in Russia, the use of low-intensity laser devices for Blood Irradiation is just beginning to spread to the United States in the late 1990s. The mechanisms of action and therapeutic effects of these two modes of BI (UVBI and LBI) are similar, yet there are subtle differences. In a study of the treatment of 312 workers who had received significant doses of radiation during the cleanup of the Chernobyl nuclear accident, UVBI was used on 54 and LBI on 126, with 132 receiving standard pharmacological treatment for a range of disorders: vegetative dystonia, dyscirculatory encephalitis, hypertonic disorder, gastro-intestinal disorders, chronic hepatitis, and chronic bronchitis. A normalization of microcirculatory and immunological indicators occurred in 73 percent of the UVBI cases and 84.8 percent of the LBI cases. But 39 of the LBI cases received an extra drug as well, and no follow-up tests were done to identify delayed effects (Frolov et al. (1995)). LBI uses the heart of the patient to pump blood over an indwelling IV fiberoptic cannula. UVBI uses an extracorporeal pump, reaction chamber and closed loop of tubing to accomplish the same irradiation.

Clinical trials in Vladivostok of the comparative effectiveness of UVBI and LBI in conjunction with fasting in the treatment of hundreds of patients with bronchial asthma yielded a nuanced but highly interesting result (G.I. Sukhanova (1993)). No differences were found in the effects on bronchiectasis (swelling of lung lobules). LBI had a more rapid effect overall and was superior in terms of bronchodilation and hyposensitization, while UVBI had a more marked bactericidal and anti-inflammatory effect. The researchers concluded that LBI's greater ease of use and more rapid effects made it superior for less serious cases of bronchial asthma, while UVBI was to be favored for more serious cases with infectious features. The differences between UVBI and LBI were not great and may have arisen from unintended differences in dosage, though the fact that the curves of the results of LBI and UVBI crossed each other as UVBI forged ahead in the second week after treatment suggests that the dosages were roughly equivalent. UVBI's superiority also showed up in four successive trials on bronchial asthma in hundreds of patients, a powerful indication that in fact it has a more profoundly therapeutic effect.

The UVBI device's advantage is that it can be used by any individual with basic medical training, thus saving the expense of physician's time and permitting its use in situations where a physician is not present. UVBI has the advantage that the blood also absorbs ambient photons that can have a beneficial effect once it returns to the body. Other ranges of the light spectrum have been found that specifically stimulate mitochondria (green) or reduce inflammation (far infrared), especially when coupled with specific porphyrins and light sensitive drugs. UV simply is the range first studied for therapeutic effects. A large body of basic science literature in Botany and Cell Biology already exists for light spectrum effects upon plant and animal cells. Clinical medicine has not yet tapped into this potential therapeutic arena of enhanced phototherapeutics.

LBI has the advantages in that the hand-held device is easy to use and the amount of irradiation can be precisely timed and calculated. LBI also does not require an extracorporeal irradiation chamber, so there is no need for cleaning quartz irradiation chambers. LBI has no requirement for an anticoagulant, a major plus in occlusive stroke, operative and trauma cases. There is, however, some concern because the laser beam, even though it is at very low intensity, does minor damage to red blood cells. Not all fiberoptics are capable of effective transmission of ultraviolet light. The specific transmissive characteristics of the fiberoptic material relative to the exact wavelength of light delivered must be considered with each study. What is generated in the laser cavity or spectrophotometer bulb enclosure could be altered or attenuated by the fiberoptic. Nevertheless, both variable wavelength optical parametric (OPO) lasers and monochromator lights with spectral filters can be designed for fiberoptic blood irradiation.

Many approaches for LBI have been tried. A particularly effective one is to use in 30 minute sessions a helium-neon laser with 1-5 milliwatt output at the tip of a polymer-coated quartz fiber (ranging from 200 to 600 micrometers in diameter) inserted into a vein with an IV needle. For serious chronic disorders like rheumatoid arthritis and schizophrenia, the sessions are repeated daily 5-15 times, depending on the patient's condition. Raising the wattage seems to convey little or no benefit, as the spectrum of light irradiation is far more important than the gross amount of photons. As with UVBI, repeated small doses of LBI have better cumulative effects than the same total dosage administered in a single session.

It is true that no long-term studies of UVBI or LBI effects have been done. However, BI of both forms is much lower in intensity and far less concentrated on a specific target than were the x-ray treatments of the 1930s and 1940s that led to cancers decades later. The relatively rapid turnover of the blood cell population also reduces the impact of BI. In contrast to x-rays, little of the UV radiation from the Russian UVBI device is ionizing and in UV-A devices, none of it is. None of the currently used LBI devices emits ionizing radiation. Logic and anecdotal evidence suggest that UVBI has a prophylactic action against cancer. An East German study of mutagenicity in chromosomes before and after six sessions of UVBI found that, in fact, chromosomal aberrations had diminished in number, leading to the hypothesis that UVBI could actually stimulate DNA repair (Frick (1989)). There is also not a shred of evidence that properly dosed BI consistently damages any specific organ or tissue of the body such as lymph nodes other than the minor damage that it does to the membranes of many red and white blood cells.

If BI is so safe and effective, why is it so little known outside of Russia and Ukraine? Medicine in Western and technologically advanced East Asian countries has gone down the path of molecular biology and pharmaceuticals. Physicians and researchers trained in biochemistry (and often with very little knowledge of physics) sometimes look askance at biophysical approaches, though some start to take BI seriously once they learn more about it. Statements regarding the broad effects of BI can easily be associated with the myriad specious claims of wonderfully curative devices by enthusiasts and charlatans. The present association of BI with things Russian can hurt it in the eyes of those who are aware of the financial and technical weaknesses of the Russian medical system. The general low prestige of Soviet and East German communist systems as well as the lingering effects of Western Cold War propaganda against them have led to a tendency to belittle the genuine but little-known contributions of their scientists.

The lack of Russian and German language skills among Anglo-Saxon and East Asian researchers leads to a mentality in which it is hard for some to accept that there could be a cutting-edge therapy like LBI on which almost none of the scientific literature is in English. Many physicians have surprisingly little knowledge of the real history of their own specialties; they know the textbook history and the English language medical literature of the past 25 years, neither of which includes BI. In turn, this leads to an NIH (Not Invented Here) syndrome, the irony being that BI was invented in the USA, and the Russians were Johnnies-come-lately to it. Since the mid-1950s, the few American practitioners of UVBI have chosen to treat patients quietly rather than do battle with state medical boards. The effectiveness of UVBI ensures that they do a steady, lucrative business with patients who prefer their services to those of colleagues. The relatively low cost of BI has never attracted a major medical corporation to back it, yet organizing clinical trials to validate BI will require considerable effort and financial resources. Lastly, the difficulty of discovering the underlying mechanism of action of BI long deprived its advocates of a valuable weapon. UVBI slipped through the cracks between standard and alternative medicine.
 

The NIH has a track record of dismissing promising, original approaches that eventually turn out to be highly beneficial. Its lapses in regard to Magnetic Resonance Imaging and the homocysteine theory of heart disease are cases in point. NIH has known about BI for years, but it has refused to put a penny into seriously investigating it - a classic case of scientific rejectionism. In the light of the formidable evidence regarding the effectiveness and safety of BI, NIH's dismissive attitude should be considered more a matter of curiosity than of consequence. Also, it is worth noting that BI can no longer be termed "innovative." It has been around for 70 years, has been exhaustively studied, has been used on millions of patients, and is well-characterized.

Russian physicians have UV irradiated marrow cells to successfully treat osteomyelitis, cerebral spinal fluid to treat multiple sclerosis, and portal blood to treat hepatitis. Ukrainian physicians are experimenting with pulsed LBI timed to the patient's heartbeat in order to optimize the effects of a given dosage and, with the help of computers, take a step toward the goal of real-time monitoring of LBI. In Odessa they are experimenting with the use of noncoherent light for BI from a monochromator light source.

The original Soviet regulatory documentation for the UVBI device listed the following contraindications (reasons for not using) related to bleeding, excessive depolymerization and states of excess oxidation:

• Bleeding stroke
• Hemorrhage or potent anticoagulation
• Photodermatitis or presence of a UV light sensitizing drug such as sulfas and psoralens
• Hypoglycemia and advanced Diabetes Mellitus with neovascularization
• Advanced COPD emphysema
• Inflammatory osteoarthritis
• Scurvey (Vitamin C deficiency)

UVBI and LBI have been used in Russia in careful studies with great effectiveness and safety to correct fetal and pregnancy conditions hard to treat with drugs, as well as infections, hypoxia, and slow growth of newborns (Matsuyev et al. (1990), p. 8). In a clinical trial of 91 pregnant women with preeclampsia, the 61 who received LBI for 7 days in a row had only 20 percent of caesareans and induced premature births on account of the disease whereas 30 controls had 31 percent of caesareans, all on account of severe preeclampsia, as well as 30 percent of induced premature births. The babies born to the LBI group were virtually identical in weight and height to those of a third group of 11 healthy controls (Bednarskii et al. (1995)). In the United States, where preeclampsia is the second leading cause of mortality in pregnancy and a significant cause of fetal defects and deaths, there is no treatment for severe preeclampsia other than induced preterm delivery.

Both forms of blood irradiation have side effects very similar to ozonized terpene and porphyrin infusion.

• Flushing of skin in some cases
• Destruction of some immune cells, depending on the dose
• In cases of disseminated infection or cancer, the rapid destruction of high numbers of infectious organisms or malignant cell can temporarily create toxic symptoms (Herxheimer reactions) that subside as the organisms or cell are cleared from the blood. These symptoms can be as mild as muscle cramps or diarrhea or as severe as shock or death.
• In 50 percent of bronchial asthma patients, there is a flare-up of symptoms following the first treatment with BI. Similar flare-ups can occur in rheumatoid arthritis. Subsequent treatments are uneventful.

While some practitioners consider BI to be without any damaging side effects whatsoever, one well-informed German source (Frick (1989), pp. 54-55) reported side effects in 15.3 percent of cases (84 of 550), including hypoglycemic shock (4 cases, probably diabetics or others with a tendency toward hypoglycemia), allergy (10), tiredness (7), fever (7), inflammatory responses in tooth root granulomas (5), gastritis (4, one case of which required cessation of BI therapy), and exacerbation of asthma (2, in one case requiring cessation of BI therapy). Frick admitted that his list included various phenomena that may not be connected with BI at all and that many of the reactions were trivial. He regularly administered up to 10 treatments of UVBI, and sometimes more, at frequent intervals. His patient population was also unusually old, averaging 53.7 years; thus it was a good deal more likely to report side effects than a more resilient youthful population. Frick himself considered the incidence of side effects to be low.

A Russian study of 2,380 sessions of UVBI revealed that 1.3 percent of patients had minor complications, hematomas at the IV site, coagulation in the tubing, shivering, dizziness, and nosebleeds. In addition, one had hypoglycemia, one had bronchospasms characteristic of her reaction to other treatments, and one had a nettle rash (urticaria) (Marochkov et al. (1990)). These German and Russian findings as well as Knott's experiments with dogs suggest something very plausible: that BI actually has a profile of damage to vulnerable sets of body cells that closely parallels that of nucleoside analogue chemotherapy. The difference from chemotherapy is that BI's greater specificity gives it a considerably higher therapeutic ceiling than competing chemotherapies (or herbal remedies, for that matter), so such damage only occurs with a relatively very high dose of BI.

Both UVBI and LBI have been tested extensively in government sponsored clinical trials, particularly in Russia and Ukraine. In recent years these trials have been employing increasingly strict protocols, including controls and sophisticated statistical analysis, though double-blinding, proper randomization, and multicenter trials are still not the norm. Another difficulty in assessing BI's effects arises from the tendency to employ BI as part of combination therapy rather than as a stand-alone treatment. And often there is no report of long-term followup. Several trials and studies with historical controls were carried out in the US, but none since around 1960. Much of the early American reporting on UVBI consisted of series of case reports. In general, the Russian and Ukrainian results have a higher validity than earlier American and German ones. The Russian and Ukrainian laboratory and clinical studies have been more rigorous and are based on a much more sophisticated understanding of immunology and general medicine than was available 50 years ago. In addition, they have not been subject to the commercial forces that shape and sometimes corrupt the clinical trial process in Western countries.

In the 1980s Yale University researchers independently developed a method of blood irradiation that is termed "photopheresis" or Extracorporeal Photochemotherapy (Edelson (1988). This article in Scientific American did not mention UVBI or the work of the UVBI pioneers although the author had cited the 1928 UVBI device patent in his own patent application). They use photoactive drugs, filters, and separation of the white blood cells from the red blood cells in the plasma. This treatment costs $2,000, requires sophisticated equipment, and takes many hours. Photopheresis uses a low-intensity fluorescent source of UV-A while the Russian UVBI device employs a high-intensity mercury-quartz source of UV-B or UV-C for production of superoxide anion radicals. In effect, photopheresis is a combination of UVBI and chemotherapy in which the secondary radiation triggers the photoactive drug previously taken up by the target cells. Thus to achieve the same effect, photopheresis uses less irradiation and more chemotherapy than UVBI.

The re-radiating substances used in photopheresis are generally drugs, psoralens, which occur in nature but are used in chemotherapeutic concentrations that can have more toxic effects than other forms of UVBI (Edelson (1991)). The two therapies appear to have roughly the same effectiveness, with UVBI presumably having an edge with equal doses of "medicine" (i.e., of toxicity) because of its higher specificity. Photopheresis is probably effective for most of the indications UVBI is effective for, and the opposite is presumably also true. Photopheresis with psoralen drug has these comparative advantages:

• It is approved by the FDA for the treatment of cutaneous T-cell lymphoma
• It is currently in clinical trials for other indications
• Hundreds of photobiologists have studied it
• There are many recent English-language publications on it
• It is available in many medical centers, which appreciate the pharmacological link to the psoralen activator.

An important implication of the FDA approval of photopheresis is that the FDA thereby accepted the principle that a therapeutic use of UVBI could be both safe and effective. UVBI has the comparative advantages over photopheresis in that:

• Both the UVBI device and the treatment are much less expensive
• The duration of the UVBI treatment is briefer
• The UVBI device can be used by any individual with basic medical training
• The UVBI device is more portable
• UVBI has been used successfully on a wider range of indications for many more years
• UVBI's activation of red blood cells temporarily transforms them into a dynamic component of the immune system
• The apparent exceptionally high specificity of UVBI may make it "cleaner" than photopheresis, which relies on chemotherapy.

Everything that is said about UVBI's effects appears to apply to LBI as well, though there are subtle differences in their patterns of action.

Most UVBI practitioners conclude that it is ineffective against solid tumors and hematological malignancies, though there are isolated reports of successes. In a telling incident, a physician treating an elderly woman for cancer discovered that UVBI had little or no effect on her cancer but caused a plantar wart of 25 years' standing to disappear (Douglass (1996), pp. 139-50). UVBI by itself is a virus killer, not a tumor killer. This case suggests, however, that UVBI can reduce cancer rates by treating the viral diseases that give rise to various tumors. In the case of plantar warts, for instance, verruca plantaris is a human papilloma virus (HPV) akin to the HPV of genital warts that has recently been implicated in the etiology of over 90 percent of cervical cancers. Unlike other antiviral agents, UVBI has an action that does not depend on the precise fit between its chemical structure and the molecular arrangement of a given virus. Therefore, if it indeed is effective against one kind of HPV, it is very probably effective against another. Thus the antiviral property of UVBI is of potential major interest in oncology.

UVBI's results against Parkinson's disease have been disappointing, and its track record against multiple sclerosis is not as good as might be expected. UVBI cannot reverse the effects of autoimmune diseases, but it can in some cases limit or stop their progress. In effect, UVBI is a Disease-Modifying Antirheumatic Drug (DMARD). From the perspective of UVBI, these autoimmune disorders are all the same disease. Some viral or chlamydial agent, toxin, or physical trauma has altered the cells in the affected region so as to make them appear strange to the immune system, which dispatches T-cells to orchestrate an immune response to them. UVBI acts to suppress the excessive metabolic activity that this autoimmune response represents. In similar fashion, a recent Russian study suggests that LBI is effective against metabolic disorders of genetic origin (reported at the November, 1996, International Laser Medicine Conference in Moscow). Thus UVBI may be effective in limiting the progress of such disorders as multiple sclerosis and muscular dystrophy, though it cannot reverse damage already done.

Russian researchers have reported excellent results with UVBI in the treatment of neurological disorders. Berdichevskii and Dashkovskaia (1991), for instance, treated 90 patients aged 47-69 with atherosclerotic, hypertonic, and venous circulatory dysfunction refractory to other treatments or gaining only short remissions with them. There were 35 controls. 4 to 8 UVBI treatments were given. Positive results were obtained with 87 percent of patients, including a full resolution of 51.2 percent of the neurological symptoms of the 37 atherosclerotic patients. UVBI treatment caused the disappearance or significant decrease of headaches, dizziness, tinnitus, feeling of heaviness in the head, pain in the heart region, etc. Sleep was normalized as well. In most positive cases, the results were long lasting or permanent.

UVBI therapy can be used as a substitute for topical or systemic glucocorticoids in the treatment of uveitis and other indications in ophthalmology. Evidence regarding its effectiveness as a treatment for anemia is mixed, probably depending on the kind of anemia in question. In contrast, its powerful action in the treatment of circulatory blockages in the legs can prevent gangrene and thus obviate the need for amputations. It also appears to work very well as a means of speeding wound healing.

In addition to the very clear, consistent pattern of effectiveness reported in studies by scores of researchers in different countries at different times, there is striking internal evidence that shows how trustworthy the sources and information about UVBI are. For instance, the forebearance of Knott and his medical collaborators in waiting five years after the initial highly successful treatment in 1928 in order to observe the first patient before treating a second one was a remarkable example of scientific probity. These people were serious, ethical scientists. To voice skepticism about findings of such power is a clear mark of bias. Although Knott's initial results in the dog experiments should have made it clear that UVBI is no mere placebo, certain critics persist in attributing its effects to psychological causes. American, German, and Russian researchers have, however, repeatedly studied this question in clinical trials. They have consistently found that a placebo-like effect occurs frequently but that even when it does, UVBI's physiological action indisputably surpasses placebo. The curious reality is that UVBI has no serious critics. A serious critic would read widely in the UVBI medical literature, carefully study the photobiological and pharmacological mechanisms of UVBI, consult extensively with UVBI practitioners, and conduct well conceived and objective clinical trials. Nor do there appear to be any serious criticisms of UVBI, i.e., criticisms that are based on in-depth knowledge and evidence.

The question "Does UVBI work?" is not a useful one because it fails to place the therapy in a context. In a sense, all therapies "work." One could speak of a Principle of Therapeutic Correspondence: Every source of energy has a corresponding therapeutic range. The proper questions with UVBI, LBI, or any other medicinal or biophysical therapy are: "What is its therapeutic range? What are the circumstances in which it is appropriate to use, and what effects does it obtain in those circumstances? How does it compare to other therapies? What are the counter-indications?" One helpful approach is to keep in mind the famous dictum of Paracelsus: "All things are poison, and nothing is without poison. It is the dose alone that makes a thing not a poison." From this perspective, even the most appealing and non-intrusive form of natural medicine can be a poison if it is employed to excess or in improper circumstances. One could do serious damage to a patient with a massive overdose of UVBI, just as one could with a massive overdose of Prozac, aspirin, or any other drug or natural remedy on the market. But with the right dose of UVBI, one can bring back to good health a patient with one foot in the grave (Olney (1946), p. 235). In fact, the exceptional specificity of UVBI appears to give it a very wide range of therapeutic benefit, making it potentially safer than many or all competing therapies. Similarly, the question "Is it safe?" is not helpful. It can lead to a bottomless pit of doubt whereby every piece of evidence of the safe application of UVBI is met with the further question: "But isn't it possible that UVBI causes some hidden systematic damage?" That approach is ultimately paranoid. The correct scientific questions are: "What are the level and pattern of UVBI's toxicity? How do they compare with those of competing therapies?"

Depreciating out the invested price of the UVBI device over five hundred infusions and making a rough estimate of the cost of disposable accessories of $80 per use yields an approximate wholesale cost of $150 for each use of the equipment and accessories. Infusion of catalysts such as ozonized terpenes and porphyrins adds another $150 per session. If each treatment requires one half hour total of set-up, treatment, and clean-up by one nurse and medical assistant @ $50 per hour, then the total cost would be $350. Adding $150 for doctor's professional time would bring the total to $500 per session. There may be other pertinent cost-related considerations. The Russian researchers repeatedly report significant reductions in the length and frequency of hospital stays because UVBI is more effective than competing chemotherapies in many indications. In addition, many patients with debilitating diseases that have made them invalids are able to return to work following UVBI. Timely intervention with UVBI can also save on the expense of operations such as amputations of diseased legs in diabetes.