I first met Nicholas Gonzalez in New York in March 1990. At the time, Gonzalez, an M.D., had been treating cancer patients in his small midtown office for three years, and there was a growing buzz in alternative medicine circles about the youthful-looking, Ivy League-educated cancer doctor. But he was still relatively unknown outside of those circles.
Gonzalez and I met over dinner at Souen, a funky macrobiotic restaurant in Greenwich Village. Gonzalez was intense and passionate about his work, and that night around the table of brown rice, beans and miso soup, there was a strong feeling of "us vs. them," "them" being the medical establishment.
Gonzalez reminded me of so many medical pioneers before him, standing alone against the powers that be. His immediate prospects looked daunting.
And they were. In 1994 he was investigated and reprimanded by the New York State medical board for "departing from accepted practice." Although efforts to remove his license failed, he was forced to undergo retraining. Meanwhile, his critics called him a variety of names, including "notorious quack," and criticized his therapies as "voodoo magic" and "worse than ridiculous." He was pilloried in the media.
But now, a decade later, Gonzalez is in a position unlike any other practitioner in the history of alternative cancer medicine. He has emerged as a credible leader in the field--not only in the view of proponents of alternative medicine, but to important political allies as well, including Rep. Dan Burton (R-Ind.), head of the House Committee on Government Reform, which has held a number of hearings on alternative therapies--and in the heart of the cancer research community. While battles remain to be fought, the future looks considerably more promising than it did that night we had dinner together.
Gonzalez is now in the midst of conducting a groundbreaking clinical trial supported by a $1.4 million grant from the National Cancer Institute, the largest grant the government has ever given to a clinician to test an alternative cancer treatment to chemotherapy.
Gonzalez treats cancer exclusively with nutritional therapies. For the past decade and a half, he has labored toward the ambitious goal of establishing his treatment as a primary, viable and widely accepted clinical option. The NCI study is being overseen by the prestigious Columbia-Presbyterian Medical Center, part of Columbia University's College of Physicians and Surgeons, and will ultimately involve between 80 and 90 patients with metastasized pancreatic cancer.
Unlike clinicians who participated in earlier government-supported clinical trials of alternative cancer treatments (for example, vitamin C or Laetrile in the 1980s), Gonzalez and longtime associate Linda Lee Isaacs, M.D., are treating study patients in their own clinical setting and closely overseeing their day-to-day care.
"My goal, because I come out of an orthodox-trained background, is to have my work properly tested," Gonzalez says. "I'm not interested in writing the five-day enzyme diet and celebrity cookbook. We've turned down six book contracts in the last two or three years. We're not interested in doing that."
The pilot study
In June 1993, Gonzalez was invited by Michael J. Friedman, M.D., then associate director of the cancer evaluation program at the National Cancer Institute, to present a review of 25 of his treated cases to the NCI in Bethesda, Maryland. Afterward, Friedman suggested to Gonzalez that he pursue a pilot study of his treatment on patients with pancreatic cancer and come back to the NCI with the results. Friedman suggested pancreatic cancer because it is one of the most difficult kinds of cancer to treat, and any results Gonzalez produced would therefore be taken more seriously.
The late Ernst Wynder, M.D., who 50 years ago was the first scientist to firmly establish the link between tobacco smoking and cancer, helped Gonzalez secure funding for the pilot study from Nestec, part of the Nestlé food conglomerate. Gonzalez and Isaacs monitored 11 pancreatic cancer patients who they treated in their office between 1993 and 1996. In their 1999 report in the peer-reviewed medical journal Nutrition and Cancer, the two doctors reported impressive survival rates of patients treated exclusively with an organic diet, nutritional supplements, enzymes and coffee enemas.
Pancreatic cancer is one of the deadliest forms of the disease. Patients treated conventionally have just 25% one-year and 10% two-year survival rates. The average length of survival is only 5.5 months. Says Gonzalez, "Of 11 patients followed in our trial, eight suffered stage IV disease," the most advanced form, in which the cancer has spread and is considered to be terminal. "Nine lived one year, [of those nine] five lived two years, four lived three years and two have lived longer than four years. In comparison, in a recent trial of the newly approved drug gemcitabine, of 126 patients with pancreatic cancer not a single patient lived longer than 19 months."
Combined with Gonzalez's low-key and effective lobbying over the years, the results of that pilot were impressive enough to lead the NCI to award $1.4 million to Gonzalez and Isaacs in late 1999.
John A. Chabot, M.D., chief of hepatobiliary and pancreatic surgery at Columbia-Presbyterian Medical Center, is the principal investigator of the NCI study. Chabot told the Boston Globe, "Frankly, when I first read [about the pilot study] I said, 'That can't possibly work.' Then I read the pilot data [and] said, 'There really might be something there.' I had to come to grips with it myself. I have no idea how or why it might work, but the data is compelling enough that I can't ignore it. It doesn't matter what the underlying theory is about why it works. That's something for us to investigate once we demonstrate that it works.''
Background of the Gonzalez therapy
Gonzalez is quick to point out that his nontoxic, nutritionally based enzyme treatment was pioneered by others, including Scottish embryologist John Beard. In an article in the British Medical Journal in 1906, Beard wrote that pancreatic proteolytic enzymes are the body's main defense against cancer and would be useful as a cancer treatment. Beard's thesis, expanded in his 1911 book The Enzyme Treatment of Cancer, was discussed to a limited extent in the scientific literature of the time but never widely applied, until it was picked up and expanded a half century later by William Donald Kelley, a Texas dentist.
Kelley was active in the field of underground alternative cancer therapies for two decades, starting in the mid-1960s. He said that his inspiration for developing nutrition-based treatments was his own case of pancreatic cancer, which he claimed to have cured without resorting to conventional treatments. Tailoring his treatments to what he described as each patient's unique "metabolic type," Kelley added coffee enemas (based on the work of Max Gerson, M.D., and others), special diets and nutritional supplements to Beard's high doses of enzymes. During the 1970s and early 1980s, Kelley developed a wide following and treated thousands of cancer patients.
In 1970, Gonzalez graduated Phi Beta Kappa from Brown University; he entered medical school at Cornell in 1979. There he studied the work of Kelley; a student project evolved into a formal, multi-year research effort. Gonzalez reviewed nearly 10,000 of Kelley's patient records, interviewing and intensively evaluating more than 500 of Kelley's patients. He summarized his results in a 1986 monograph entitled "One Man Alone." The monograph discusses at length 50 of Kelley's patients initially diagnosed with a variety of poor-prognosis cancers, each of whom enjoyed long-term survival or apparent regression of disease while following Kelley's regimen.
Gonzalez was unable to get "One Man Alone" published. In 1987, he opened a private practice in New York and began to treat cancer patients with the enzyme-based nutritional therapies he learned from Kelley. Gonzalez's goal, he has written, was "to try and salvage the enzyme approach, and observe for myself the results with poor-prognosis cancer patients. My goal throughout has been to generate research support, so that this method, if it indeed proved to have value, could be integrated into general medical treatment."
Since 1987, Gonzalez has treated more than 1,000 cancer patients. He points out that a number of his original patients, some of whom were stage IV when they began treatment, are still alive. Gonzalez's protocol involves three basic components: enzymes, diet (including supplements) and detoxification. Following Beard's thesis, the most important anticancer element of the program is large doses of pancreatic enzymes (derived from pig pancreas after the animals are slaughtered for meat).
In contrast to many alternative doctors, who have one diet they use for all cancers, Gonzalez and Isaacs utilize ten different diets as part of their clinical practice--ranging from pure vegetarian to red meat three times a day, depending on the type of cancer the patient has. Pancreatic cancer treatment, for example, calls for a nearly all-vegetarian diet. The average cancer patient takes more than 100 capsules throughout the day--vitamins, minerals, antioxidants and trace elements. These also vary according to each individual's needs.
The last component of the program is the detoxification routines, which include coffee enemas. "We use simple techniques, which ironically come out of the orthodox literature, that seem to help the liver get better--the liver is where all of the tumor waste and the metabolic wastes are processed in the body," says Gonzalez. "As the cancer dies, you get all of this waste material, and it has to be processed and eliminated. Most of that is done through the liver. The coffee enemas and the other detoxification procedures we use seem to help the liver work better.
"The interesting thing about our program, although we use it to treat advanced cancer and 80% of our patients have cancer, is that it's very good preventatively. In terms of preventative approaches, I think it's the single best approach you can have, because it's so individualized."
To the question of why there is so much cancer in modern society and what we could be doing to prevent more of it from occurring, Gonzalez says, "The only thing that surprises me is that there isn't more cancer, the way people live. It's just an extraordinary testament to how well-designed the human body is. When you basically destroy the environment, live on food that is not suitable for anybody to eat, do abusive things like smoke, use drugs and drink alcohol, then the only thing that amazes me is that there isn't more cancer."
The NCI study
Columbia University is responsible for recruiting between 80 and 90 newly diagnosed pancreatic cancer patients for the study, half of whom are to be given state-of-the-art conventional chemotherapy, and half of whom will be in the nutrition-only patient group treated by Gonzalez and Isaacs. The patients in Gonzalez's group must be between 18 and 65 and cannot have had any radiation or chemotherapy.
Patients that are assigned to the chemotherapy arm will receive gemcitabine and any other currently accepted chemotherapy regimens for pancreatic cancer. Chemotherapy and drugs will be administered on an outpatient basis by a medical oncologist. In a letter from Chabot's office to prospective patients, the specific requirements of the Gonzalez protocol are described as such: "The diet is not strictly vegetarian and does allow some limited animal products. Specifically, you would be expected to eat one to two eggs daily, yogurt daily and fish twice weekly. Red meat and poultry, however, are strictly forbidden. Fried foods, white sugar products such as candy, cakes and carbonated beverages, artificial sweeteners, alcoholic beverages and all refined, white flour products are also completely forbidden.
"In terms of supplements, patients will be required to ingest in the range of 140 capsules a day, spread throughout the day. In addition, each patient takes large numbers of specifically formulated pancreatic proteolytic enzymes. The third component of the treatment, the detoxification routines, involves procedures such as coffee enemas.ÉCoffee enemas must be done twice each day and are a critically important part of the treatment."
Gonzalez knows that the requirements of his nutritional therapy can be a challenge for some people, and he says that a few participants dropped out because they were not prepared. "For a patient," he says, "this isn't like orthodox medicine, where you watch TV while the doctor gives you the medication. Our patients have to do it themselves. And we have to have patients who are willing to do it."
The future
Two and a half years into his study, Gonzalez says, "The NCI has really been great to work with. Their attitude is that they want this [study] to work." Now he just needs research subjects willing to try his enzyme and nutrition therapy instead of chemotherapy. "We're up to a total of 16 patients now. And considering there are 30,000 cases of pancreatic cancer diagnosed a year in the United States, it's unbelievable that we don't have the 40 or 45 that we need in our nutritional group." The patients that he does have, he adds, are mostly stage IV, and are clearly responding.
To help attract more patients to the study, the NCI sent out a letter in January to 20,000 doctors, including every oncologist in the United States, calling the study a "top priority" and urging doctors to cooperate and send patients to Gonzalez and Isaacs.
"The problem has been the oncologists out in the field. And I think some of it is financial," says Gonzalez. "They can make $20,000 with a course of chemotherapy for pancreatic cancer even though it doesn't work. It's 'standard of care' and it's covered by insurance. And if they refer a patient into our study, the patient has to be previously untreated. The doctors would have to give up control of the patient and lose income. [Some] oncologists have their own competing studies with chemo regimens, and they're not about to give up patients to us."
Just about all of the patients in the study, according to Gonzalez, heard about it through word of mouth, the Internet or articles. To the doctors who are in a position to refer research patients to him, Gonzalez has a simple plea: "Even if they thought I was a dangerous fraud, what a wonderful opportunity this is to get the issue resolved. Just refer 45 patients and let me make a public, national fool of myself, and that's the end of it."
Another reason Gonzalez may be having trouble getting referrals--his reports of clinical success and the large government grant notwithstanding--is the bad publicity he received during the 1990s when the mainstream media seized on his medical board censure to depict Gonzalez as, at best, a questionable clinician.
Since 1999, however, media coverage of his work has generally been better. Gonzalez's published study, the federal grant and growing interest in his work in academic circles have all helped. Recent reporting has included an article in the Boston Globe, a feature report on CNN in November of 1999, a page-one story in the Washington Post in January of 2000, two reports on ABC-TV news within one week during June 2000 and a lengthy article in a February 2001 issue of the New Yorker. With the notable exception of one of the ABC-TV reports and the Post article, the coverage has been fairly positive.
Still, support among doctors is lagging. Says Gonzalez: "It's been rather perplexing that with 30,000 pancreatic cancer cases a year--the oncologists certainly at this point know about our study, because it's been in the oncology journals--they aren't referring more patients to us. If there's something of value in what we're doing, which I personally believe there is, then it's a tragedy. And if they don't believe there's something valuable, they should be anxious to get that proven, too. So there's no reason, whether they believe in it or don't believe in it, that they're not referring more patients."
People with pancreatic cancer who have not previously undergone chemotherapy can inquire about enrolling in the NCI study by contacting the office of John Chabot, M.D., at 212-305-9468.