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Dr. Gonzalez's Regimen
By Jesse Eisenger
With roots in turn-of-the-century Scotland, an unorthodox treatment
has worked powerful magic against a few cases of pancreatic cancer.
Will it pass scientific muster and prove a potent cancer fighter?
In order to find out, Dr. Gonzalez needs patients willing to enter
a clinical trial.
On most days, Morton Schneider wakes up and takes a pill. This
isn’t unusual for many 77-year-olds in his retirement community
outside Orlando, Florida. But in Schneider’s case, by the time the
sun goes down he’s taken more than 150. He considers these pills
lifesavers.
In late 1991, Schneider, a retired bookkeeper for an industrial
glove company, was diagnosed with a cancerous lung tumor. Worse,
doctors discovered tumors in his liver, adrenal glands, and his
pancreas, the probable source. He was given only a few weeks to
live. "I had no pain, no symptoms," says Schneider. "It
was discovered quite accidentally – and just in the nick of time."
Almost eight years later, Morton is alive and well, adhering to
an intensive dietary program called the Gonzalez Regimen. The regimen
is named after New York immunologist Nicholas Gonzalez, MD. It’s
a complex routine that calls for dietary restrictions, coffee enemas,
and the key ingredient: lots of pancreatic enzymes from pigs.
"What I do is controversial," says Dr. Gonzalez, "but
our early results have convinced the National Cancer Institute to
fund a clinical trial. We can evaluate my methods in an academic
setting."
The fifth leading cause of cancer death in the United States, pancreatic
cancer strikes nearly 28,000 patients each year. Their outlook is
grim. Four of five die within a year. Only one in 20 patients survives
five years after diagnosis.
Surgery can help, but for most patients the tumor is inoperable
by the time the diagnosis is made. Current therapy – drugs such
as Gemzar (gemcitabine) — has extended patients’ lives only by a
few months.
The situation cries out for a different approach.
At the turn of the century, an embryologist at the University of
Edinburgh named John Beard was studying placentas. He noted that
in every species, as the placenta grows in the uterus, it invades
like a tumor. Beard wondered exactly what prevented a normal placenta
from growing into a cancer. He discovered that the placenta stopped
growing the day the fetal pancreas started working.
A Theory Revised
First came the correlation; then came the leap of faith. The embryologist
figured that if pancreatic enzymes could halt placental growth,
they just might work against cancerous tumors as well.
But Beard’s theory was largely forgotten.
At least, until the 1960s, when a few unorthodox therapists, notably
an orthodontist named William Donald Kelley, revived Beard’s idea.
As a medical student in the early 1980s, Dr. Gonzalez learned of
Beard’s and Kelley’s work and sought to expand on the theories.
He reviewed the records of 1,306 cancer patients treated over a
20-year period with pancreatic enzyme therapy. Dr. Gonzalez discovered
that some of the patients who had pancreatic cancer survived more
than five years.
Such a retrospective look, while encouraging, wasn’t enough. Dr.
Gonzalez wanted to test the regimen scientifically, so he conducted
a pilot study from 1993 to 1996 with 11 patients. Earlier this year
he published results from that study in the medical journal Nutrition
and Cancer.
All of Dr. Gonzalez’s pilot-study patients suffered from inoperable
pancreatic cancer. Nine of the 11 survived at least 1 year, five
survived 2 years, and four survived 3 years. Two patients are still
alive. This compares with a major study of Gemzar in which the average
patient survived less than 6 months, and no patients lived for more
than 19 months.
"Someone said there can’t be two kinds of medicine – conventional
and alternative. There’s only medicine that has been scientifically
tested and medicine that has not," says Dr. Gonzalez. "If
you believe in medicine that is based on data, then we have to test
this treatment further, in a clinical trial."
As with many early-stage trials, the pilot study was limited in
scope. Dr. Gonzalez’s therapy wasn’t tested against a control group.
Now he wants his regimen held to the same standards by which drugs
are tested. And he has scored some major allies.
Ernst Wynder, MD (see "The Vindication of Ernst Wynder,"
page 56), the renowned scientist credited with first making a link
between cancer and smoking, wrote a forceful defense of the enzyme
work. In an accompanying editorial to the Nutrition and Cancer study,
Dr. Wynder called alternative treatments "important and justified,
especially in view of their remarkable lack of adverse effects and
as hope offered to patients."
Rep. Dan Burton (R-Indiana), who has long been a proponent of alternative
cancer therapies and a critic of what he considers the National
Cancer Institute’s "neglect" of such remedies, set up
a meeting with Dr. Gonzalez and Richard Klausner, MD, head of the
NCI. A new trial was decided upon.
Dr. Gonzalez and his colleagues were awarded $250,000 a year for
5 years by the recently established Office of Cancer Complementary
and Alternative Medicine. Their mission is to apply scientific methods
to assess alternative medicine. The enzyme trial is one of only
two such tests that the NCI’s special alternative therapies office
is conducting. "We’re committed to trials of alternative therapies,"
Dr. Klausner told InTouch, " as long as they go through
the review process and are of as high quality as this one."
The phase III trial of the Gonzalez Regimen will enroll 72 to 90
patients. It will be run by John Chabot, MD, a surgical oncologist
at New York Presbyterian Hospital, and by faculty at Columbia University
School of Medicine. In a phase III trial, scientists randomly assign
patients to one of two groups. One group receives the new treatment
– in this case, Dr. Gonzalez’s regimen. The second group gets the
standard therapy – in this case, the drug Gemzar.
"The only way we can know which of these two treatments works
better is by directly comparing them in a rigorously designed and
run clinical trial," says Dr. Chabot.
Morton Schneider can tell you one thing: The Gonzalez Regimen isn’t
easy. Patients must eat copious amounts of raw fruits, raw and lightly
steamed vegetables and juices, and plant-based proteins, such as
cereals and nuts, including 20 almonds a day. No red meat or chicken
is allowed, but patients can have some fish. No refined grain products
and no white sugar. No soy, because it interacts with the pancreatic
enzymes.
Perhaps hardest of all, patients take up to 150 pills a day: 25
to 40 grams (40 pills) of freeze-dried pancreatic enzymes derived
from pigs, plus vitamins, minerals, amino acids, trace elements,
and glandular extracts.
The enzyme pills must be ingested evenly throughout the day. According
to the hypothesis, that’s the key to fighting pancreatic cancer:
patients must take the enzymes on an empty stomach. Most patients
take the pills for 15 days, stop for 5 days, then resume the pills
again.
The Price Of Health
"It takes a lot of courage, a lot of strength, and a lot of
persistence," says Morton Schneider’s wife, Evelyn. "
And a lot of money," she adds. The Schneiders estimate they
spent $6,000 on the regimen last year, and around $20,000 altogether
on health care. (The Gonzalez trial will cover the cost of the pills
as well as any office visits directly related to the study.)
Some friends of the Schneiders who have been diagnosed with cancer
have turned down Dr. Gonzalez, intimidated by the regimen’s intensity.
And by the coffee enemas (even though the liquid isn’t hot). The
enemas are part of the "detoxification" period, to cleanse
the body of impurities. For 5 days after each 15-day "pill
periods," the patient either drinks citrus juice for 2 days,
eating no solid food, or undergoes a "liver flush." During
this procedure, Morton Schneider and other patients drink organic
apple juice, take Epsom salts and olive oil, and sleep curled up
on their left side when they go to bed. This helps clean out the
system.
A third cleansing routine calls for taking a Metamucil-like product
in conjunction with various herbs. If the regimen sounds hard, well,
Dr. Gonzalez says he doesn’t ask his patients to do anything he
wouldn’t do himself. He adheres to his own regimen to prevent
cancer. In fact, so does Evelyn Schneider, Morton’s wife.
Worth The Cost
When Betty Frizzell was diagnosed with pancreatic cancer in December
1995, her doctor told her she had less than 6 months to live. Frizzell,
64, heard about Dr. Gonzalez and his colleague, Linda Isaacs, MD,
from a friend who gave her a video describing his regimen.
"The more I thought about it, the more it made sense,"
says Frizzell, a retired schoolteacher. "It was a healthy approach.
When I watched that video, I told myself: ‘I can do this.’"
Frizzell agreed to join the pilot study in 1996.
Frizzell lives on a farm about 80 miles outside of Nashville, four
miles from where she was born. To supplement her diet she raises
a veritable cornucopia in her organic garden, even as her husband
makes his living raising a small herd of beef cattle – although
beef, ironically, is strictly forbidden on the Gonzalez regimen.
"I feel wonderful, I’m able to work and see my six grandchildren
frequently," says Frizzell. "I wouldn’t be here today
if I hadn’t chosen this route."
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