DR. GONZALEZ�S REGIMEN

By Jesse Eisenger

Reprinted with permission of InTouch: The Good Health Guide to Cancer Prevention and Treatment. Subscription information: Call toll-free 1-877-2-INTOUCH (1-877-246-8682).  For more information, contact intouch@cancernetwork.com or www.cancernetwork.com.

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."