June 15, 2000 (Arlington, Va.) -- After months of delays and years of debate, researchers are finally enrolling patients for a study designed to see if an unorthodox treatment regimen, including vitamins and coffee enemas, can shrink the tumors of patients with cancer of the pancreas.
The controversial method already has kept nine of 11 patients who took part in a preliminary study alive for a year, while another person survived for five years, says Nicholas Gonzalez, MD. Gonzalez has received $1.4 million from the National Center for Complementary and Alternative Medicine, in partnership with the National Cancer Institute, to do a three-year study of the treatment. Gonzalez is director of the Nutritional Research and Educational Foundation in New York.
If the FDA were to approve the method for treating pancreatic cancer, it would be "a major revolution," Gonzalez tells WebMD. "This would be the first time that an alternative therapy went through the testing process by the best and most stringent of academic criteria, and got approved as a treatment."
The study's original goal was to compare patients on chemotherapy with those using the coffee-enema method. But Gonzalez says it was impossible to recruit patients willing to settle for standard chemotherapy. So the study has been reorganized to allow participants to choose the type of treatment they wish.
"Patients know in this day and age chemotherapy is a death sentence" for pancreatic cancer, Gonzalez said here at the recent Comprehensive Cancer Care 2000 conference, which was aimed at exploring alternative approaches to treatment. For the study to show success, participants on the coffee-enema regimen will have to live about 15 months, or three times the typical survival time for pancreatic cancer patients -- results Gonzalez already has achieved in the small initial study.
While Gonzalez will supervise the project, the research actually will be conducted at Columbia Presbyterian Medical Center in New York.
Here's how the program works: Gonzalez puts his patients on a restrictive, mostly vegetarian diet and gives them up to 160 capsules a day, including vitamins as well as natural pancreatic substances that he believes slow tumor growth. Coffee enemas are added twice daily to help "detoxify" the system.
Gonzalez says he's hopeful the FDA ultimately will approve his method, and that, even though the treatments are natural, they can be patented. "The drug companies aren't dumb," Gonzalez says. "They'll use moon dust if you can prove it works."
Over the years, Gonzalez' treatments have come under attack from the medical mainstream. He has persevered through two lawsuits, as well as criticism from the New York state medical board. Gonzalez attributes his problems to "hostility" from the establishment.
Part of that hostility, counters Charles Staley, MD, is that alternative therapies are seldom studied in a scientific way. And this is a problem here. "If alternative medicine wants to show its benefits, it needs to do so using the same standards everything else is assessed by," says Staley, who is an assistant professor of surgery and a specialist in pancreatic cancer at Emory University School of Medicine in Atlanta.
Staley says for doctors to be able to compare this treatment with standard care, the study needs to be designed so patients are randomly assigned to each group. "I've never seen a trial that says the study will allow the patients to choose their treatment," he says. Without a scientific set up, he says, the study lets bias creep in and the results come into question.
The findings may seem interesting, but researchers can't make strong enough conclusions in order to advise how patients should be treated. At some point, he says, the researcher will have to have enough confidence in this treatment to compare it with standard therapy in a scientific study. Until then, the findings can't be helpful.
Earlier, Sen. Tom Harkin, (D-Iowa), a strong congressional booster of alternative treatments, told those attending the three-day meeting that federal support for the National Center for Complementary and Alternative Medicine has grown dramatically, from $2 million in the early '90s to the current budget request of $100 million. Still, he says, that's just a fraction of total budget for the center's parent agency, the National Institutes of Health.
"To me, it's just the height of stupidity for our conventional [physicians] to say, 'Well, they shouldn't do this', when we know how many Americans are involved in taking herbal remedies," Harkin tells WebMD. Harkin also says a White House commission to study policy issues related to dietary supplements will be launched next month, with a $1 million budget.
Staley adds that he doesn't discourage his patients from trying herbal treatments along with their traditional therapy. "I just tell them not to spend their life savings on them."
- Although the mainstream medical community is often skeptical of alternative medical treatments, the government is funding research to determine whether they actually work.
- One new study will examine a treatment regimen that includes vitamins and coffee enemas in hopes it will shrink tumors in the pancreas.
- According to one researcher, nine of 11 pancreatic cancer patients have been kept alive for one year, and one patient has lived for five years, using only this unorthodox treatment.