Guest guest Posted October 5, 2003 Report Share Posted October 5, 2003 Sun, 5 Oct 2003 22:22:30 -0400 (EDT) THE MOSS REPORTS Newsletter (10/05/03) ---------------------- Ralph W. Moss, Ph.D. Weekly CancerDecisions.com Newsletter #102 10/05/03 ---------------------- A FRIENDLY SKEPTIC LOOKS AT GALAVIT™ I first came across Galavit in November 2000, while on a tour of German complementary and alternative (CAM) cancer clinics. There had been an enthusiastic article in March of that year on the supposedly successful cancer treatment of a well-known European actor, 77-year-old Ivan Desny, after using a Russian medicine. One clinic in Bavaria that I visited was busy administering this very expensive product, which they described as an " immune stimulant undergoing clinical trials. " It was all very hush-hush and mysterious. They could show me no documentation on the product, no clinical results or Phase I safety studies. The product was Galavit. Shortly thereafter, a media frenzy erupted in Germany on this very topic. Claims and allegations went back and forth between proponents and members of the medical establishment. Then, in October 2001, German newspapers ran exposes that the celebrated Mr. Desny had never actually had cancer at all, but had simply " played the part " of a terminal cancer patient on behalf of a friend who wanted to market this product! The German website on this topic, www.galavit.de, shut down after exposure of " der Schwindel " (as the Germans called it) and the whole topic seemed relegated to the dustbin of history. In the meantime, due to the pervasiveness of the Internet, and the seeming immortality of even the most erroneous statements posted there, Galavit lives on around the world: there are presently over 370 websites that still mention it. Most of these are in German and Russian, but over 50 English-language sites discuss or even offer Galavit for sale. One very well known CAM practitioner has seemingly made great claims for its effectiveness against cancer…although in a phone conversation he recently told me that he had totally withdrawn his support. Here at the Moss Reports, we continue to get a great many inquiries regarding the effectiveness of this purported cancer cure. At the Russian Galavit website (www.galavit.ru), which still operates, one can find some basic information on the product, although I have not independently verified the claims made there. Galavit is said to be a white or light yellow crystalline powder which can be dissolved in saline solution or water to produce an injectable form. The active substance is a derivative of phthalhydrazide. (The word is misspelled at the site.) Some newspaper accounts have identified it as amino tetrahydrophthalozin sodium salt. Phthalhydrazine is an analog (or look-alike) of a common chemical substance called luminol (Bottu 1991). This is a chemiluminescent, a substance whose oxidation is accompanied by a striking emission of light. Luminol is commonly used to disclose the presence of microbes, for example in high school science experiments. It is also used in forensic criminology to detect traces of blood that are invisible to the naked eye. The cost of laboratory-grade luminol is around $5 per gram (1,000 milligrams). The manufacturer and owner of the Galavit trademark is a closed joint stock company called " Tsentr Sovremennoy Meditsiny, " i.e., the Center of Modern Medicine, which is abbreviated as Medicor. Its Russian Registration Certificate was approved (we are told) by the State Pharmacological Committee on March 31, 1997. The General of the company is Mr. Valery H. Zhilov. I received no reply to an email sent to the address provided for him. Mode of Action Galavit is said to have both anti-inflammatory and immune modulating activity. Its major pharmacological effect is on the macrophage, which is a scavenging immune cell. In inflammatory diseases, Galavit supposedly inhibits the overproduction of various pro-inflammatory cytokines, such as tumor necrosis factor (TNF) and interleukin-1, as well as active oxygen species ( " free radicals " ). Normalizing macrophages is said to lead to a concomitant decrease in autoimmune reactions and a recovery of normal T-cell functions. Galavit is also said to stimulate the bacteria-killing activity of neutrophils (a type of white blood cell), thereby enhancing resistance to infectious diseases. In Russia, Galavit is reportedly prescribed for the treatment of acute infectious diseases of many types as well as for chronic inflammatory diseases, including those that have an autoimmune component (such as ulcers, ulcerative colitis, Crohn's disease, liver diseases, rheumatoid arthritis, etc). It has also been used to treat immune deficiencies arising in cancer patients as a side effect of radiation and chemotherapy. Dosages and Administration Galavit is administered intramuscularly. It comes in 10-milliliter vials containing 100 milligrams of the drug. The shelf life in a cool dark place is said to be two years. The dosage and length of treatment depend on the character, severity and duration of the illness. I will not speak about the use of Galavit for patients other than those with cancer. But for the correction of immune deficiencies in cancer patients who are also receiving radiotherapy and chemotherapy the starting dose is said to be 100 milligrams every other day for 5 injections, then once in 3 days for a total of 20 injections. It has been difficult to substantiate the actual nature and clinical effects of Galavit, in part because of language and cultural differences. However, all over the world true scientists speak one language, i.e., that of peer-reviewed research. If one searches PubMed, a standard medical database of 12 million such citations, one finds just two references to Galavit. The first is from a Russian journal and relates to the treatment of chronic stomach ulcers, not cancer. The other, published in a standard Western journal, refers to a study of Galavit's effects on cytokine production in lab animals infected with Astrakhan spotted fever and North Asian scrub typhus. Again, not cancer. This latter article concludes that " therapy with Galavit reduced manifestations of the disease, decreased mortality of experimental animals, and decreased the concentrations of interleukin-1 and tumor necrosis factor to normal value. " This is good news if you happen to be an animal with Astrakhan spotted fever, but there are no articles in PubMed that relate to the use of Galavit in treating cancer in humans. Much of the enthusiasm for Galavit in the English-speaking world has been generated by a single practitioner, Dr. Kurt Donsbach. He is a chiropractor who directs the Santa Monica clinic of Rosarita Beach, Mexico, which also has a branch in Poland. In his long and controversial career, Dr. Donsbach has advocated many alternative cancer treatments. In March 2001, he wrote in his 'Let's Talk' newsletter that he had attended a meeting in Romania along with " a limited group of oncologists from around the world, " the purpose of which was to launch Galavit outside Russia. He reported that the product was first developed in Obninsk, Russia, " by their astronaut medical team, who were under orders to create a substance that would protect the Russian astronauts from the high doses of radiation they could be subject to during their long periods in space and from the possible emergence of tumors from such exposure to radiation. " He claimed that Major General Dr. Victor Ljutov, of Medicine for the Air Force and Space Travel, used Galavit on 300 cosmonauts and " a further 30,000 cancer patients successfully. " In some cases Galavit was used alone, in others it was used in conjunction with orthodox cancer therapy. I have no way to independently validate or refute any of these claims, but many of them were later contested in the German media. It certainly seems incredible that Dr. Ljutov could have treated 30,000 cancer patients yet no mention of this work ever made it into the standard medical database! If you search for " Dr. Victor Ljutov " on the Internet there are no references at all except those by Dr. Donsbach himself and there are also zero articles by a Dr. Victor Ljutov in PubMed. According to Dr. Donsbach, the result of this experimentation was as follows: Galavit stimulated the immune system against cancer cells. Galavit stopped the growth of primary tumors. Galavit prevented metastasis. Galavit promoted the regeneration of diseased organ and body tissue. Galavit increased dramatically the life expectancy of cancer patients. Galavit drastically improved the quality of life of even the most terminal cancer patient. Galavit reduced the side effects of radiation and chemotherapy. Donsbach commented at the time: " I don't know of any substance which has anywhere near the broad spectrum application or the dramatic results of this product. " Realizing the sweeping nature of these claims, he added, " Anyone can make claims such as I offered here, but I am convinced after attending this conference, that they are true. " (TO BE CONCLUDED, WITH REFERENCES, NEXT WEEK) --Ralph W. Moss, PhD --------------- IMPORTANT DISCLAIMER The news and other items in this newsletter are intended for informational purposes only. 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