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In what may be one of the fastest drug approvals ever, the FDA has approved Gleevec for the treatment of chronic myelogenous leukemia (CML) in patients who have failed standard therapy. Health and Human Services Secretary Tommy Thompson made the announcement May 10, 2001, and called drugs like Gleevec "the wave of the future."


Gleevec, formerly spelled "Glivec," was also known as STI-571. Below is what I published in May, 2000, one year before this drug gained approval. My goal is to give you a heads-up on what is going on, not only in the alternative arena, but also in the drug arena as well. Remember you read it here first. -- Angel


Chronic Mylogenous Leukemia (CML)


There is now a pill to reverse CML, a type of leukemia in which an abnormal chromosome produces an enzyme that leads to the uncontrolled growth of white blood cells. The drug kills leukemia cells by targeting a specific abnormal gene contained inside the cell--without harming normal cells.


The first clinical trials in Oregon and at UCLA and the M.D. Anderson Cancer Center in Houston were designed to find out whether the drug is safe and how much the body can tolerate. Patients took daily doses of 25 to 500 milligrams.


Fifty-four people, all of whom either never responded or were no longer responding to interferon, have taken the drug for at least four weeks. The white blood cell count dropped by more than half in every patient who has taken at least 140 mg a day of the drug, and all 31 taking at least 300 mg have normal white and red blood cell counts. In some of these patients the chromosomal defect is starting to disappear.


For example, a patient in the trial started the study with a 125,000 white blood cell count (normal is 10,000 or below). A week into the treatment, her count had dropped to 60,000 and within three weeks it was normal. The results of this first trial were so successful that new trials are currently under way in 19 medical

centers with about 200 patients, and 600 more to be enrolled later.


The man behind all this is Dr. Brian Druker. For 10 years he studied a group of enzymes found in the cells of CML patients, and tried to find a way to block them. One specific enzyme, tyrosine kinase, is believed to cause more than 97 percent of all cases. Druker and researchers from Novartis Pharmaceuticals found a way to stop that enzyme six years ago and have been testing and refining it ever since with a compound called STI-571.


STI-571 could become the first major treatment for this kind of leukemia since

interferon shots were introduced in 1986. Interferon, a natural protein that revs up the body’s immune defenses, is the current standard treatment for CML and cures up to one-third of those with the disease. However, it can take two years of daily shots of interferon to get remission. And interferon has many side effects, including pain and inflammation of the joints. STI-571’s side effects are few and mild, and it is available in pill form.


Will this new drug’s effects last? Will the cancer develop a resistance? Will there be any long term side effects? It's too early to tell but even if the effects are short-lived, this is an important study that could have ramifications in the search for treatments of other cancers. And since this goes to the root of the cause to eliminate the abnormal gene, it may produce a permanent cure. Perhaps conventional medicine is finally catching on to treating the cause instead of the symptom. Dr. Brian Druker is to be commended. We can only hope that others will follow his lead.


Now if someone could figure out what causes the abnormal gene, perhaps we could prevent the disease from ever occurring. That mystery may be left to the field of Alternative Medicine.


For more information on this topic or to participate in the clinical trials for STI-571, contact Novartis Oncology Clinical Trials (800) 340-6843. To contact Dr. Brian Druker, call the Oregon Health Sciences University in Portland, Oregon (503) 494-1117. He is also listed on the Physician's Reference List.


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