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
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
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
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